Healthcare Sector Ideas

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>>> IDEXX Laboratories (NASDAQ:IDXX) is a global leader in veterinary diagnostics, software and water microbiology testing. The company’s innovative products and services help veterinarians deliver high-quality care and enable early detection and treatment of pet diseases. IDEXX’s strong competitive position, global presence and innovation focus position it well for continued growth. The increasing humanization of pets, the growing demand for veterinary care and the rising awareness of early disease detection’s importance are key megatrends supporting IDEXX’s long-term prospects.

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https://finance.yahoo.com/news/ai-bot-predicts-7-stocks-175326496.html


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>>> Simulations Plus (NASDAQ:SLP) is a leading modeling and simulation software provider for drug discovery and development. The company’s innovative software platform helps pharmaceutical and biotechnology companies accelerate the drug development process, reduce costs and improve success rates. Simulations Plus’ strong market position, expanding customer base and focus on innovation position are good for continued growth. The increasing complexity of drug discovery, the growing demand for efficient drug development processes and the rising adoption of computer-aided drug design are key megatrends that support Simulations Plus’ long-term prospects.

This is another stock in the healthcare industry sort of in the same boat as TCMD. Do not expect massive returns, but the possible gains are significant enough to include in a high-risk, high-reward basket of stocks. The company beat top-line estimates by nearly 6% in the recent quarter and has some of the best margin and cash positions, with negligible debt and $108 million in cash. Revenue growth is expected to be around 15% annually and 20-30% EPS growth going forward. However, you are paying a hefty premium for this stock, so I do not think life-changing returns are possible. However, it is still one of the AI stock picks worth buying for potential double-digit returns.

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https://finance.yahoo.com/news/ai-bot-predicts-7-stocks-175326496.html


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>>> Why big Medicare Advantage insurers may root for Biden to lose in 2024

The Biden administration has delivered consecutive blows to the industry that offers private-sector Medicare alternatives


Yahoo Finance

by Janna Herron

Apr 11, 2024


https://finance.yahoo.com/news/why-big-medicare-advantage-insurers-may-root-for-biden-to-lose-in-2024-080028510.html


Insurance giants have a bigger stake in this year’s presidential election after recent moves by the Biden administration cut into the profitability of Medicare Advantage plans.

In the last week, the Centers for Medicare and Medicaid Services (CMS) delivered consecutive blows to the industry that offers these private-sector Medicare alternatives, denting insurance stocks and pulling down estimates of future earnings.

Insurers will get paid less than expected next year for providing these plans, while, at the same time, they must abide by new, and probably costlier, regulations. Other key changes rolling out over the next three years could also nick their bottom lines.

The industry expects a second term for President Joe Biden would bring more of the same at a time when the youngest baby boomers become Medicare-eligible and more of the older ones seek healthcare services.

"Do I want to say it's a historic level of regulations? If it's not, it's got to be close to it," Whit Mayo, an analyst with Leerink Partners, told Yahoo Finance. "Biden is no friend to the industry right now."

'A major change'

The new regulations have come hard and fast recently.

Last week, the government said it would increase its payments to Medicare Advantage (MA) insurers by 3.7% in 2025. That’s "marginally worse" than the earlier proposed rate, Mayo said, and “inconsistent with almost any historic precedent.”

It also caught the industry by surprise because many expected CMS to incorporate the uptick in healthcare service volumes in the fourth quarter.

A few days later, CMS finalized other rules around health equity, behavioral healthcare services, and supplemental benefits that would require more action from insurers.

The agency also established new rules on how much insurers can compensate a broker selling Medicare Advantage plans to ensure seniors are steered into plans that best meet their needs — not into ones that are most profitable.

“CMS does not want an agent to have preference over any plan based on commissions…so this is a major change,” Mayo said.

These efforts are weighing down insurer stocks.

Year to date, shares of Humana (HUM) — which has the largest exposure with MA accounts making up 77% of its total revenue — are down 30%.

The stock of UnitedHealthcare (UNH) has declined nearly 13% since the beginning of the year. MA accounts make up 31% of UnitedHealthcare's total revenue, according to Ann Hynes, managing director at Mizuho Americas.

In a note last week to investors, Hynes estimated the 3.7% increase in the MA payment rate could be a 2% and 4% "headwind" for UnitedHealthcare’s 2025 earnings, a 2% to 6% drag on both CVS Healthcare Corp.’s (CVS) and Centene Corp.’s (CNC) profits, and an 8% anchor on Humana’s bottom line.

One of the three "key upcoming catalysts" for Humana’s stock, Hynes wrote, is “the 2024 Presidential election.”

On the horizon

More change is on its way under the Biden administration’s CMS that could also upend insurance profits.

The agency recently put out a new patient risk coding model. Each patient receives a risk score based on the number and severity of their health conditions. The unhealthier the patient, the higher the risk score and the more money CMS pays to insurers.

Under the new model, risk scores will overall likely decline, meaning fewer dollars will flow to insurers. How much exactly? The model, which will be fully phased in 2025, is expected to save Medicare $11 billion this year, per CMS estimates. Next year, it will likely be more.

How Medicare Advantage plans are rated by CMS is also changing.

CMS ranks each plan annually using a one-to-five-star scale, with five being the best, based on a variety of metrics. The idea is to reward plans that provide quality care with reimbursement and bonuses while cracking down on mediocre plans by reducing CMS payments and restricting their marketing.

Over the next three years, CMS plans to increase or decrease the weighting of some measures, eliminate others, and add a health equity index to the ranking. Insurers work hard to maintain at least a four-star rating on their plans to get a 5% quality bonus, which, by law, must be invested into plan benefits.

"That's what gives you a competitive advantage in the market," Mayo said.

Insurers also remain under pressure from increasingly vocal healthcare providers, which are dropping some Medicare Advantage plans due to too many denials, delays, and refusals to pay for care that Original Medicare would usually cover.

October surprise, anyone?

Under Donald Trump, those changes may not be carried out.

"I think the perception among the investment community is that, under a Trump administration, the environment would be more favorable,” Mayo said. “Just not as much regulation, maybe even roll back."

It may be seniors — historically one of the most reliable voting blocs — who may get the last word.

Mayo expects insurers will readjust some of the MA benefits so they can grow — or at least hold — their margins in light of the recent changes, a reversal of the years-long cycle of "massive" investment in these perks.

Extras like a supplemental grocery benefit could be eliminated for next year, while the share that patients pay out of pocket for services such as dental or vision care could increase.

Seniors will see those reductions in benefits or increases in co-insurance during Medicare’s annual open enrollment period, when they choose their health insurance for next year. Open enrollment kicks off Oct. 15, less than a month before the presidential election on Nov. 5.

That means the 33 million Americans now enrolled in Medicare Advantage plans, making up over half of Medicare-eligible adults, may get mad after their plan drops benefits that enticed them to sign up in the first place.

They may carry that anger into the voting booth. That may be what insurers are hoping for.

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>>> Cal-Maine Foods, largest producer of eggs in US, finds bird flu in chickens at Texas plant


USA Today

by Natalie Neysa Alund

April 3, 2024


https://www.yahoo.com/news/cal-maine-foods-largest-producer-132035566.html


The largest supplier of eggs in the United States halted production after chickens at a Texas plant tested positive for the highly contagious bird flu - the latest in a spike of cases across the nation.

Cal-Maine Foods on Tuesday announced chickens at its facility in Parmer County, in the state's southwestern panhandle, tested positive for pathogenic avian influenza (HPAI) resulting in slaughter of nearly 2 million chickens - 1.6 million hens and 337,000 pullets (young hens).

The announcement less than 24 hours after the Centers for Disease Control reported a person in Texas had been infected with the virus after coming into close contact with dairy cattle and just over a week after sick dairy cattle in Texas and Kansas tested positive for the virus.

The culled Texas chickens represent about 3.6% of the company’s total flock as of Tuesday, the supplier wrote in a news release.

Production at the Texas facility temporarily ceased while the company follows the protocols prescribed by the U.S. Department of Agriculture, the company said.

Bird flu is spreading in a few states: Keeping your bird feeders clean can help

Cal-Maine Foods is largest producer of eggs in the nation

Headquartered in Ridgeland, Mississippi, Cal-Maine Foods is the largest producer and distributor of fresh shell eggs in the nation and said it sells most of its eggs in states across the Southwest, Southeast, Midwest and MidAtlantic.

The company said it "remains dedicated to robust biosecurity programs across its locations; however, no farm is immune from HPAI. HPAI is still present in the wild bird population and the extent of possible future outbreaks, with heightened risk during the migration seasons, cannot be predicted."

Cal-Maine Foods said it was working "to secure production from other facilities" to minimize disruption to its customers.

Human case of bird flu found in Texas: Case comes on heels of outbreak of virus among cattle

Person infected with bird flu in Texas

In a separate news alert this week, the Texas Department of State Health Services reported the patient became "ill following contact with cows presumed to be infected with avian influenza" and that their primary symptom was conjunctivitis, also known as pink eye.

The person who tested positive for bird flu in Texas is only the second known human case in the United States, state and federal officials said this week.

Bird flu in dairy cattle in Kansas, Texas

Last week the USDA announced last week HPAI had been found in unpasteurized clinical samples of milk from ill cows at two dairy farms in Kansas and one in Texas, plus a swab from a dairy cow in Texas.

Wild migratory birds are believed to be the source of the infection, the USDA said, and viral testing and epidemiologic efforts remained underway.

What is bird flu?

Bird flu is a disease caused by a family of flu viruses primarily transmitted among birds.

Avian influenza viruses, according to the CDC and USDA, are classified into two groups: low pathogenic avian influenza (LPAI) (often seen in wild birds) and HPAI, found mostly in domestic poultry. According to the CDC, LPAI viruses cause mild or no disease, and HPAI cause severe disease and high mortality rates in infected birds.

Bird flu has cost the government roughly $660 million and in recent times raised the price of eggs and poultry. At least 58 million birds were slaughtered last year to limit the spread of the virus.

Bird flu spread to humans is low risk, USDA says

The first case of avian influenza in a person in the United States was reported in Colorado in April 2022.

Federal and state health authorities are investigating the outbreaks, and the USDA said the risk to the general public contracting is low as the viruses have only rarely been transmitted from person to person.

"However, people with close contact with affected animals suspected of having avian influenza A have a higher risk of infection," Texas health officials wrote in a news alert earlier this week.

Bird flu symptoms in humans

Human infection with the bird flu can happen during close contact with infected birds or when people touch sick birds or their saliva, mucus and feces, the CDC said. People contract the virus when it gets into a their eyes, nose or mouth, or when it is inhaled.

Those who contract the virus often experience mild illnesses including an eye infection and upper respiratory symptoms or no symptoms at all, while others can develop a severe sometimes fatal disease like pneumonia.

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HUM, UNH - >>> US health insurers slide as final Medicare payment rates fall below expectations


Reuters

4-2-24


https://www.msn.com/en-us/money/markets/us-health-insurers-slide-as-final-medicare-payment-rates-fall-below-expectations/ar-BB1kWIXt?OCID=ansmsnnews11#;


(Reuters) - Shares of U.S. health insurers tumbled between 6% and 12% on Tuesday after the final 2025 rates for Medicare Advantage (MA) payments by the government implied a cut and triggered worries about a margin squeeze.

The rates, which indicated a 0.2% fall in average payments, are unchanged from what was proposed in January, despite pressure from companies and industry groups to incorporate a late-year surge in medical care demand.

The U.S. Centers for Medicare & Medicaid Services typically raises the final reimbursement from the advanced notice.

The rates could pile more pressure on margins at insurers already struggling with high medical costs, and uncertainty around insurance claims processing due to the fallout of a hack at UnitedHealth's tech unit.

Shares of Medicare-focused insurer Humana fell the most, plunging more than 12% to a near four-year low of $308.22. UnitedHealth slumped 6.6%, while CVS Health sunk 7.7% in early trading.

The steep losses also dragged down the blue-chip Dow index and the benchmark S&P 500 in morning trading. [.N]

The "less-than-favorable rate updates, which coupled with the potentially clouded claims development in light of the Change Health cyberattack ... may put the once-golden Medicare Advantage market in somewhat less favorable standing," said Citi analyst Jason Cassorla.

The CMS, in a final notice published on Monday, said it had not observed higher demand for medical care during the fourth quarter of 2023, in sharp contrast to recent comments from insurers such as Humana and UnitedHealth.

The closely watched proposal determines how much insurers can charge for monthly premiums, plan benefits they offer and, ultimately, their profits.

The high costs, coupled with low rates, put pressure on insurers to cut the number of benefits they cover, said BoFA Securities analyst Kevin Fischbeck in a note.

"The amount of benefit cuts needed could begin to weigh on the perceived value of Medicare Advantage," he said.

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>>> Pfizer Inc. (NYSE:PFE) -- Number of Hedge Fund Holders: 79

https://finance.yahoo.com/news/20-best-stocks-buy-now-183621401.html

Number of Times Stock Appeared in Top Picks of Financial Media: 3

Pfizer Inc. (NYSE:PFE) discovers, develops, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. On March 4, investment advisory Cantor Fitzgerald maintained an Overweight rating on Pfizer Inc. (NYSE:PFE) stock with a price target of $45.

Among the hedge funds being tracked by Insider Monkey, Florida-based investment firm Citadel Investment Group is a leading shareholder in Pfizer Inc. (NYSE:PFE) with 11.6 million shares worth more than $334 million.

In its Q4 2023 investor letter, Diamond Hill Capital, an asset management firm, highlighted a few stocks and Pfizer Inc. (NYSE:PFE) was one of them. Here is what the fund said:

“Among our bottom contributors in Q4 were BorgWarner and Pfizer Inc. (NYSE:PFE). Biopharmaceutical company Pfizer was pressured as COVID sales were slower than expected in Q4. However, outside COVID-related sales, the base business is performing as expected, and the company is starting a cost-cutting program that should restore margins to pre-pandemic levels. We continue to like Pfizer for its diversified business, strong cash flow generation capabilities and balance sheet, and solid leadership under a quality CEO.”

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>>> Zoetis Inc. (NYSE:ZTS) -- 14-day RSI: 32.16

https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html

Number of Hedge Fund Holders: 50

Parsippany, New Jersey-based Zoetis Inc. (NYSE:ZTS) is a leading animal health company with a portfolio and pipeline of medicines, vaccines, diagnostics, and technologies offered in over 100 countries. Formerly a subsidiary of Pfizer Inc. (NYSE:PFE), the company became independent through a spinoff in 2013.

Zoetis Inc. (NYSE:ZTS) has been continuously making efforts to increase its product franchises in major markets. During the fourth quarter, the company received approvals for Simparica Trio, the company’s triple combination oral parasiticide for dogs, in China. While the company’s injectable monoclonal antibody for the alleviation of pain associated with osteoarthritis in cats, Solensia, received approval in Brazil.

Zoetis Inc. (NYSE:ZTS) has paid regular dividends since its spinoff from Pfizer Inc. (NYSE:PFE) with consecutive dividend increases for several years. The board of directors of the company declared a dividend of $0.432 per share for Q2 2024, on February 6.

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>>> Novartis AG (NYSE:NVS) - 14-day RSI: 37.75

https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html

Number of Hedge Fund Holders: 28

Basel, Florida-based Novartis AG (NYSE:NVS) focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products.

On February 6, Novartis AG (NYSE:NVS) announced that it has entered into an agreement to acquire MorphoSys AG (NASDAQ:MOR) in a transaction implying a total value of €2.7 billion. The transaction expands and complements the company’s pipeline in oncology and enhances its global footprint in hematology.

On February 23, BMO Capital analyst Etzer Darout initiated coverage of Novartis AG (NYSE:NVS) shares with a price target of $114 with a ‘Market Perform’ rating for the shares. The target price represents a potential upside of 15.15% based on the latest share price.

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>>> Amgen, Inc. (NASDAQ:AMGN) - 14-day RSI: 37.92

https://finance.yahoo.com/news/11-oversold-blue-chip-stocks-195219274.html

Number of Hedge Fund Holders: 69

Thousand Oaks, California-based Amgen, Inc. (NASDAQ:AMGN) is a leading biotechnology company discovering, developing, manufacturing, and delivering innovative human therapeutics with a focus on areas of high unmet medical need.

On February 6, Amgen, Inc. (NASDAQ:AMGN) released its financial results for the Q4 2023. Its revenues increased by 20% y-o-y to $8.2 billion, while it generated a net income of $767 million. The normalized EPS for the quarter was recorded at $4.71, which surpassed the consensus by $0.12.

Earlier on October 6, 2023, Amgen, Inc. (NASDAQ:AMGN) completed the acquisition of Horizon Therapeutics plc in an all-cash transaction implying an equity value of nearly $27.8 billion. The acquisition strengthened the company’s inflammation portfolio by adding first-in-class, early-in-lifecycle medicines which treat rare inflammatory diseases.

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>>> UnitedHealth unit will start processing $14 billion medical claims backlog after hack


Reuters

by Leroy Leo


https://www.msn.com/en-us/money/companies/unitedhealth-unit-will-start-processing-14-billion-medical-claims-backlog-after-hack/ar-BB1kntGE?OCID=ansmsnnews11


(Reuters) - UnitedHealth Group said on Friday its Change Healthcare unit will start to process the medical claims backlog of more than $14 billion as it resumes some software services disrupted by a cyberattack last month.

The company has been scrambling to resume services at the technology unit that was hit by a cyberattack on Feb. 21, disrupting payments to U.S. doctors and healthcare facilities and forcing the U.S. government to launch a probe.

Community health centers that serve more than 30 million poor and uninsured patients have been especially hit.

The company has advanced payments of more than $2.5 billion so far to provide assistance to healthcare providers financially affected by the disruption, an increase from the over $2 billion it had disclosed on Monday. UnitedHealth also extended the repayment period for providers, who will now have 45 business days to return the relief funds.

Change Healthcare is a key player in the U.S. healthcare system that depends heavily on insurance, processing about 50% of medical claims for around 900,000 physicians, 33,000 pharmacies, 5,500 hospitals and 600 laboratories.

The unit was breached by a hacking group called ALPHV, also known as "BlackCat", creating a knock-on effect that the largest U.S. health insurer is expected to take several months from which to fully recover.

The health insurer said its software for preparing medical claims Assurance went online on Monday, while its largest clearinghouse Relay Exchange will resume on the weekend of March 23.

A clearinghouse acts as a middleman between a healthcare provider and a health plan that checks claims to ensure they do not contain errors before forwarding them for payment.

The insurer said it will work with payers to ensure there are a maximum number of available locations for claims and is actively coordinating with other clearinghouses to make sure there are no capacity issues.

UnitedHealth had suspended paperwork required to get approval for insurance coverage for most outpatient services, as well as review of inpatient admissions for government-backed Medicare Advantage plans to help those impacted.

UnitedHealth also expects to engage all those who submitted claims during the week of March 25.

The company's other products that handle eligibility of claims such as Clearance and Coverage Insight as well as pharmacy claims submission software MedRx and Reimbursement Manager are expected to go online next week.

Several more products are likely to go online over the weeks of April 1 and April 8, the company said.

Some products, however, were not listed in Friday's update as it does not yet have clarity of when they will be restored, the company said, adding it will provide updated information as those timelines become clear.

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Resmed - >>> Introducing the AirFit F40: Experience Unprecedented Freedom with the Comfort and Optimized Seal Performance of ResMed’s Smallest Full-Face CPAP Mask


GlobeNewswire

ResMed Inc.

March 6, 2024


https://finance.yahoo.com/news/introducing-airfit-f40-experience-unprecedented-140500242.html


Enhances sleep apnea therapy by combining the ease and comfort of an ultra-compact, under-the-nose full-face design with the effectiveness of a traditional over-the-nose full-face mask.

Featuring the AdaptiSeal™ cushion made of 100% soft silicone to adapt to various facial contours, allowing for a secure and comfortable seal throughout the night.

96% of patients using the AirFit F40 said they have the freedom to sleep in their preferred position and change positions through the night.1


SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- ResMed (NYSE: RMD, ASX: RMD), a global leader in digital health and cloud-connected medical devices that transform care for people with sleep apnea and other chronic respiratory diseases, today announced the U.S. launch of the AirFit F40, an ultra-compact, full-face mask offering the comfort of smaller masks without sacrificing performance in order to help improve sleep apnea therapy compliance.2

Finding the right mask with the right fit and comfort can be daunting, especially for individuals requiring high-pressure CPAP treatment. The AirFit F40 addresses this problem by providing the necessary pressure support in a more comfortable, lower-profile full-face mask. The mask is ideal for people who sleep on their side, are claustrophobic, and want the stability and seal of a universal fit mask in a minimalist design. In a ResMed clinical study, 88% of patients rated AirFit F40's mask cushion as soft and comfortable and 100% found AirFit F40 easy to use.3

"Most users prefer smaller and more streamlined masks, but traditional under-the-nose full-face masks can be challenging to fit properly, maintain a seal, and handle higher pressures. Our new AirFit F40 addresses this problem by offering the best of both worlds: an ultra-compact full-face mask with the high seal performance of an over-the-nose mask – bridging the gap between compactness and effectiveness in full-face masks,” said Justin Leong, ResMed chief product officer.

A key feature of the AirFit F40 is the AdaptiSeal™ cushion, a 100% soft silicone cushion designed to maintain a facial seal, even when moving around during sleep. Additional features include:

A fully flexible frame that keeps the assembly away from patients’ eyes and ears.

A full-face mask with a quick-release short tube, reducing tube drag and offering a convenient way to detach and reattach the mask to the device during the night.

Headgear without top strap adjustment, which makes for an easier setup and adjustment process.

A new textile material and a dark grey color, offering a more modern look.

AirFit F40 is the latest in ResMed’s family of innovative CPAP masks, connected devices, and digital health technologies for helping millions with sleep apnea, COPD, and other chronic diseases sleep, breathe, and live better.

AirFit F40 masks are available in the U.S., with plans to launch in Canada, followed by EMEA, Latin America, and APAC. For more information, visit ResMed.com/AirFitF40.

About ResMed

At ResMed (NYSE: RMD, ASX: RMD) we pioneer innovative solutions that treat and keep people out of the hospital, empowering them to live healthier, higher-quality lives. Our digital health technologies and cloud-connected medical devices transform care for people with sleep apnea, COPD, and other chronic diseases. Our comprehensive out-of-hospital software platforms support the professionals and caregivers who help people stay healthy in the home or care setting of their choice. By enabling better care, we help improve quality of life, reduce the impact of chronic disease, and lower costs for consumers and healthcare systems in more than 140 countries.

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Orchard Therapeutics - >>> A lifesaving therapy for children with a rare disease is now the world’s most expensive drug, raising questions about access


CNN

by Brenda Goodman

March 20, 2024


https://www.yahoo.com/lifestyle/fda-approved-lifesaving-therapy-children-194412723.html


A new gene therapy for the fatal genetic disorder metachromatic leukodystrophy, or MLD, will carry a wholesale price of $4.25 million, its manufacturer announced Wednesday, making it the world’s most expensive medicine.

Lenmeldy was approved by the US Food and Drug Administration on Monday and is the first therapy for the rare and devastating disease, which typically kills affected children before they turn 7. About 40 children are born with MLD in the US each year.

The wholesale cost isn’t usually what patients pay, but it’s a cost that’s considered and shouldered by public and private health insurance plans, including state Medicaid plans, which cover roughly 4 out of every 10 children in the United States.

Manufacturers of gene therapies say the big prices reflect big benefits — the chance to be free of a disabling or even fatal disease — and they point out that they need to be able to recoup the steep costs of development, testing and manufacturing their products.

Health policy experts say that as the list of gene and cell therapies with eye-popping prices grows, it may strain the ability of states and other insurers to cover their costs, and ultimately limit patient access if plans begin to exclude these therapies as a class from coverage.

Dr. Bobby Gaspar, the co-founder and CEO of Orchard Therapeutics, the company that makes Lenmeldy, said the treatment is “paradigm-shifting medicine and has the potential to stop or slow the progression of this devastating childhood disease with a single treatment.”

“We are committed to enabling broad, expedient and sustainable access to this important therapy for eligible patients with early-onset MLD in the U.S.,” Gaspar said in a statement.

Price of hope

Lenmeldy takes stem cells from someone with MLD and uses a harmless virus to insert working copies of a faulty gene. The repaired cells are then infused back to the patient, where they begin to produce an enzyme that’s lacking in children who have the disease. Some of the cells eventually migrate to the bone marrow, where they continue to live and make new cells that also make the enzyme, providing a long-lasting benefit to patients.

The first patients treated with Lenmeldy have now been followed for more than 12 years, and researchers continue to find gene-modified cells making the missing enzyme, said Orchard Therapeutics’ Gaspar.

“We can’t say at the moment that this will last a lifetime, but what we can say is that there is a longterm durable effect,” Gaspar said.

MLD is an inherited disorder, and children born with it lack an enzyme needed break down fatty substances called sulfatides. The build-up of these fatty materials eventually becomes toxic to nerves, leading to the progressive loss of movement and thinking.

Babies with MLD develop normally for a time and but then typically begin to lose the ability to walk and talk around age 2. The disease advances rapidly, causing children to deteriorate into a vegetative state.

“We are over the moon regarding what this means for other families,” said Kendra Riley, 41, of Phoenix, who has two children with MLD.

For their family, the FDA’s action this week was bittersweet.

Riley’s 5-year-old daughter, Olivia, is in hospice after being diagnosed with MLD as a toddler.

Riley says the first clues that something was wrong came when Olivia was around the age of 2. She began to have trouble walking, and her head started to regularly tilt to the side when she would watch TV.

“We thought we just needed some physical therapy,” Riley said.

“Then the irises of her eyes started vibrating. That’s when we knew something else was going on.”

By the time doctors diagnosed Olivia with MLD, it was too late for the gene therapy to help. But knowing that the condition is inherited, they were able to get their younger daughter, Keira, tested and diagnosed.

Keira, now 4, was the 32nd child in the world to get the therapy, which is most effective before children show symptoms.

The treatment wasn’t yet available in the United States, so the family crowdsourced donations to temporarily relocate to Italy in 2020 to get the therapy. It cost them about $500,000 to live abroad and pay for Keira’s medical care, even though the company provided the gene therapy for free.

“Having this FDA-approved therapy means that if a child does get diagnosed before symptom onset, they have a chance at normal life,” Riley said.

“She is doing amazing. Zero symptoms,” she said of Keira. “You would never know.”

‘Exciting’ drug development

The Boston nonprofit Institute for Clinical and Economic Review, or ICER, which evaluates the cost effectiveness of new drugs, published a final report on Lenmeldy last fall and estimated that the cost of the therapy would match its expected benefits to patients if it was priced between $2.3 million and $3.9 million.

Experts agreed that even such hefty price tag would be worth its results. Children with the disease who aren’t treated usually die within five years of their diagnosis; the oldest patient to have the therapy has now been followed for more than 12 years and appears to be developing normally.

“It’s taking a child who would have had a miserable short life and likely giving them a normal life. And that’s worth a lot of money,” said Dr. David Rind, the chief medical officer for ICER. “This is one of the more exciting drugs that we’ve looked at.”

Still, the Lenmeldy’s price came in hundreds of thousands of dollars higher that even Rind expected.

“I think when you get into numbers this big that people don’t necessarily pay attention when it gets a little bigger, but I do think this price is too high,” Rind said.

ICER gave a range of $2.29 million to $3.94 million — that doesn’t mean that the top of the range is the right price, said Rind “despite the desire by manufacturers to think of it that way.”

“Going $310,000 above the very top of that range is actually a lot of money,” he said.

The last product to top the charts on a per-treatment basis was another gene therapy called Hemgenix, which was approved in 2022 to treat a blood clotting disorder called hemophilia B. Its list price was $3.5 million for a one-time treatment.

Close behind that one is Elvevidys, which was approved in 2023 for muscular dystrophy at $3.2 million, and Skysona, approved in 2022 for a disease related to MLD called adrenoleukodystrophy, which costs $3 million for a one-time dose.

Even with a top tier price, the MLD treatment will not be a blockbuster, Rind noted, because the disease is so rare. Some gene therapies approved for rare diseases have disappeared because the companies that made them couldn’t make enough money to stay in business. Orchard Therapeutics has already struggled to market a previous gene therapy it developed, leaving patients hanging.

Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, worries about the impact to states, which share the cost of covering patients on Medicaid with the federal government.

Medicaid requires a minimum rebate from drug manufacturers, but without any competition, there probably won’t be much negotiation about the price of the therapy, Park said.

More and more states are closely following drug pipelines after being surprised by the costs of the antiviral medications that cure hepatitis C, he said.

But even paying for one or two children to get Lenmeldy a year could be a sizeable cost for some states to absorb.

“Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes,” Park said.

New possibilities for patients

This latest approval comes as the FDA is working to clear a backlog of cell and gene therapies that have been waiting for its attention since the pandemic. The agency has hired more staff to review the new treatments and set up a new superoffice, the Office of Therapeutic Products, to oversee their regulation.

Lenmeldy has been available in Europe since 2020, but it took four more years to bring it to the US.

Dr. Nicole Verdun, who was hired to head the new FDA initiative last year, said Lenmeldy’s approval is a sign that things are moving in the right direction.

“MLD is a devastating disease that profoundly affects the quality of life of patients and their families,” Verdun said.

“This approval represents important progress in the advancement and availability of effective treatments, including gene therapies, for rare diseases.”

Dr. Barbara Burton, who is an attending physician, of genetics, genomics and metabolism at the Ann & Robert H. Lurie Children’s Hospital of Chicago, said it was a watershed moment for doctors, too.

“For too long, my colleagues and I have consoled families at their most vulnerable times — usually following an arduous diagnostic odyssey, coping with a dire prognosis and being told there were no treatments, and then having to watch their young child slip away.

“With this approval, we are now one significant step closer to ensuring future generations of children, families and healthcare professionals no longer need to experience first-hand the terrible manifestations this disease has on untreated patients,” she said.

The approval of a treatment is already leading to new ways to catch the disease earlier.

Gaspar, of Orchard Therapeutics, noted that the company was supporting studies of newborn screening tests in the hopes of catching and treating the condition earlier, and screening is happening in some US states.

“Over 250,000 babies have been screened them as a result of these initiatives,” Gaspar said, and five babies with MLD have been identified. At least three of those babies have now been treated.

Riley said she wishes screening had been available for Olivia. The 5-year-old is stable for now, but Riley said she lives in fear that Keira could bring germs home.

“The common cold could kill her,” Riley said. “So every time her sister has come home with a cold from school, that could be potentially something that takes her out.”

Olivia can’t walk or talk, and she’s fed through a tube. Riley says she requires round-the-clock care. Physical and occupational therapists come to the house each week “to keep her mind moving. She does understand what’s going on.”

She said that as they have watched Olivia slip away, they’ve come to understand that her life has had profound purpose. But they say they hope that the approval of Lenmeldy means that no other families with MLD will have to lose one child to save another.

“We’ve always called Livvy ‘Keira’s guardian angel on Earth,’ ” Riley said. “She’s here for a reason.”

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>>> Will Novo Nordisk Overtake Eli Lilly as the Most Valuable Healthcare Stock?


David Jagielski

Motley Fool

March 20, 2024


https://finance.yahoo.com/news/novo-nordisk-overtake-eli-lilly-123000972.html


Novo Nordisk (NYSE: NVO) and Eli Lilly (NYSE: LLY) are the top two healthcare stocks in the world based on market cap. Their diabetes and weight loss medications are a big reason these have been among the best healthcare investments to own over the past few years. Today, Eli Lilly is the larger of the two companies, with a market cap of more than $700 billion. Novo Nordisk, however, isn't too far behind, sporting a valuation about $600 billion. And there are some recent catalysts that suggest that gap could shrink in the future.

Why Novo Nordisk could soar higher this year

Novo Nordisk stock is up 28% so far in 2024, and there are a couple of reasons it may become an even hotter in the weeks and months ahead.

On March 8, the Food and Drug Administration approved Novo Nordisk's weight loss treatment, Wegovy, for a new indication: reducing cardiovascular risk in obese or overweight adults. Up until then, the drug was only approved as a treatment for weight loss. The label expansion gives patients another reason to use the drug, which could result in more prescriptions and insurance coverage -- and thus, more revenue.

Novo Nordisk has also been working on a weight loss pill (Wegovy is an injectable) that has been demonstrating encouraging results in clinical trials, showing that it can achieve faster weight loss than Wegovy: 13% after 12 weeks versus just 6% with the injectable treatment. It was an early-stage trial but the data is promising nonetheless.

In 2023, Novo Nordisk's sales increased by 36% (when excluding the impact of foreign exchange) to 232.3 billion Danish kroner ($34.8 billion). Wegovy's sales of 31.3 billion Danish kroner soared by a staggering 420%. And with much more potential on the horizon with a new indication for Wegovy and it entering new markets, Novo Nordisk is nowhere near done growing. Having a weight loss pill in development that could be even better than Wegovy gives investors even more reason to stay bullish on the stock for the long haul.

Could Eli Lilly's stock struggle?

Novo Nordisk is more of a pure-play weight loss and diabetes investment, whereas Eli Lilly's business is much more diversified. And that diversification is one of the reasons the healthcare stock may stumble a bit this year. Recently, regulators delayed making a decision on Eli Lilly's Alzheimer's treatment, donanemab. While it's likely to still obtain approval, the stock fell on the news.

In addition to diabetes treatments, Eli Lilly's top five treatments for the last three months of 2023 featured a breast cancer drug (Verzenio) and psoriasis medication (Taltz). While weight loss is a big growth opportunity for Eli Lilly, with recently approved Zepbound just starting to generate revenue for the business, its operations are certainly broader than Novo Nordisk's.

Another reason the healthcare stock could face pressure this year is that it trades at a lofty 60 times forward earnings, which is based on analyst expectations of where its profits will be in the next year. By comparison, Novo Nordisk trades at a multiple of 39. With a much higher premium, there's more pressure for Eli Lilly to deliver on not just its weight loss and diabetes treatments but on its other drugs as well.

Will Novo Nordisk become the more valuable healthcare stock?

Over the past month, shares of Eli Lilly have fallen by about 3% while Novo Nordisk stock has risen by close to 7%. The gap is shrinking between these two companies and there's a possibility it narrows even more narrow later this year, depending on how these businesses perform.

I don't, however, expect Novo Nordisk to become the more valuable company. Eli Lilly is simply too strong, and with Zepbound in its very early innings of generating revenue and the approval of donanemab still a strong possibility, the recent pullback in price may only prove to be temporary.

Overall, these are two solid healthcare stocks and whichever you decide to invest in may ultimately depend on whether you prefer to focus on the broader and pricier business (Eli Lilly) or a slightly cheaper company whose priorities center around diabetes and weight loss (Novo Nordisk). But with stellar results and exciting futures ahead, both of these stocks can be great buys.

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>>> ResMed Inc. (RMD) develops, manufactures, distributes, and markets medical devices and cloud-based software applications for the healthcare markets. It operates in two segments, Sleep and Respiratory Care, and Software as a Service. It offers various products and solutions for a range of respiratory disorders, including technologies to be applied in medical and consumer products, ventilation devices, diagnostic products, mask systems for use in the hospital and home, headgear and other accessories, dental devices, and cloud-based software informatics solutions to manage patient outcomes, as well as provides customer and business processes. The company also provides AirView, a cloud-based system that enables remote monitoring and changing of patients' device settings; myAir, a personalized therapy management application for patients with sleep apnea that provides support, education, and troubleshooting tools for increased patient engagement and improved compliance; U-Sleep, a compliance monitoring solution that enables home medical equipment (HME) to streamline their sleep programs; connectivity module and propeller solutions; and Propeller portal. It offers out-of-hospital software solution, such as Brightree business management software and service solutions to providers of HME, pharmacy, home infusion, orthotics, and prosthetics services; MatrixCare care management and related ancillary solutions to senior living, skilled nursing, life plan communities, home health, home care, and hospice organizations, as well as related accountable care organizations; HEALTHCAREfirst that offers electronic health record, software, billing and coding services, and analytics for home health and hospice agencies; and MEDIFOX DAN's software solutions. The company markets its products to sleep clinics, home healthcare dealers, and hospitals through a network of distributors and direct sales force. The company was founded in 1989 and is headquartered in San Diego, California. <<<



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>>> GEHC / General Electric Co (NYSE:GE)

https://www.insidermonkey.com/blog/5-best-wind-power-and-solar-stocks-to-buy-3-1262185/5/

Number of Hedge Fund Investors: 92

With a gigantic green energy arm Vernova, General Electric Co (NYSE:GE) is among the top favorite wind power and solar stocks to buy according to hedge funds. General Electric Co (NYSE:GE) plans to spin off its Vernova unit by April 2024 after which Vernova would be a publicly traded company. Vernova has 55,000 wind turbines and 7,000 gas turbines. General Electric Co (NYSE:GE) says its technology helps generate a whopping 30% of the world’s electricity.

A total of 92 hedge funds tracked by Insider Monkey had stakes in General Electric Co (NYSE:GE) as of the end of the fourth quarter of 2023.

Longleaf Partners Fund stated the following regarding General Electric Company (NYSE:GE) in its fourth quarter 2023 investor letter:

“General Electric Company (NYSE:GE) – Industrial conglomerate General Electric (GE) was the top performer for the year. We exited this multi-year investment as its price went above our appraisal. In 1Q23, GE spun out GE Healthcare, which we sold as it traded at our value. The share price continued its strong performance throughout the spring and summer, and we ultimately sold the position in the third quarter when we no longer saw a margin of safety for the business. CEO Larry Culp was a great partner who created significant value for shareholders by reducing leverage, cutting costs, streamlining operations, improving company culture and simplifying the structure with plans to split the company into three businesses. We hope to have the opportunity to partner with him again in the future.”

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Pfizer - >>> 2 Dirt Cheap Dividend Stocks to Buy and Hold


by Prosper Junior Bakiny

Motley Fool

March 11, 2024


https://finance.yahoo.com/news/2-dirt-cheap-dividend-stocks-134500534.html


Dividend stocks are great for several reasons. Some use the regular payouts they offer to complement their income, whether in retirement or otherwise, while others reinvest the money to boost long-term returns. Dividend stocks have generally outperformed their non-dividend-paying peers over long periods.

Clearly, this mode of investing has advantages, but if there's one thing better than investing in dividend stocks, it's investing in cheap dividend stocks. Let's consider two companies that fit the bill: Pfizer (NYSE: PFE) and Viatris (NASDAQ: VTRS).

1. Pfizer

Last year, Pfizer's revenue dropped by 42% year over year to $58.5 billion. The decline was due to the receding pandemic. Demand for Pfizer's COVID-19 vaccine, Comirnaty, and its related medicine, Paxlovid, dropped off a cliff. Still, the drugmaker's current slump won't last forever.

Pfizer already has a plan to turn over a new leaf. Last year, it earned approval in the U.S. for seven brand-new products, more than double any of its competitors' total for 2023.These products will eventually help Pfizer's revenue start moving in the right direction.

It's also worth noting that Pfizer's underlying business, excluding its coronavirus portfolio, isn't performing that badly: Revenue increased by a solid 7% year over year in 2023. Pfizer's decision to join the COVID-19 market has been a net positive despite its current declining top-line. It became the company in the pharmaceutical industry to hit $100 billion in sales in 2023 thanks to it. The money it generated allowed it to invest in the future.

Pfizer made important acquisitions, including that of cancer specialist Seagen, for $43 billion. Seagen was already a successful oncology-focused biotech before having access to the kinds of funds Pfizer has. The newly formed entity under Pfizer should speed up innovation compared with what it would have been able to accomplish by itself. Pfizer plans on increasing the number of blockbuster cancer medicines in its portfolio to eight by 2030, up from five today.

Of course, Pfizer is also active in many other areas, from immunology to infectious diseases. It's developing an influenza vaccine to help address the low efficacy of currently available options. The drugmaker is also working on a combined COVID/flu vaccine. Both are in late-stage studies. Pfizer boasts 112 candidates in its pipeline. The company should significantly improve its lineup in the next few years, even more than it already has.

As for the dividend, the company has increased its payouts by just under 17% in the past five years. It offers a forward dividend yield of 6.18%. Lastly, Pfizer's forward price-to-earnings (P/E) ratio is just 12, compared with a forward P/E of 18.4 for the pharmaceutical industry. So Pfizer looks like an attractively valued dividend stock by this popular metric.

2. Viatris

Viatris hasn't been a standalone, publicly traded corporation for very long. The company was created when Pfizer's former subsidiary, off-patent drug specialist Upjohn, merged with the corporation then known as Mylan N.V., which focused on developing and marketing generic drugs, back in late 2020.

The company's position in the market for generic and branded pharmaceutical products is enviable. It owns several popular brands that should continue attracting customers for a long time. These include Viagra, Xanax, Lipitor, and more. This business creates a somewhat stable source of revenue for the company.

Viatris has also significantly changed its operations recently by shedding lower-growth opportunity segments. For instance, it got rid of its biosimilar and women's healthcare units. Besides cutting off low-growth opportunities, Viatris planned to pay off debt while investing in more potentially lucrative avenues.

The company created a new eye care division through acquisitions and announced a research and development partnership with Switzerland-based pharmaceutical company Idorsia. Viatris added two potential blockbuster candidates to its late-stage pipeline through the Idorsia deal, while it expects its new eye care unit to add more than $1 billion in annual sales by 2028.

Viatris has struggled with top-line growth. Last year, its net sales of $15.4 billion remained flat on an adjusted basis (that is, taking into account acquisitions and divestitures). However, thanks to recent business changes, the company could make significant progress on that front in the years ahead. Meanwhile, Viatris offers a forward yield of 3.89%, though it has increased its dividend just once since it became a standalone company.

Viatris' forward P/E ratio of 4.4 looks more than reasonable. For income seekers willing to stay the course for a while, Viatris looks like a good option.

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>>> Stryker Corporation (NYSE:SYK) - Number of Hedge Fund Holders: 47

https://finance.yahoo.com/news/14-best-robotics-stocks-buy-194148400.html

Stryker Corporation (NYSE:SYK) is a medical technology company operating in two segments – MedSurg and Neurotechnology, and Orthopaedics and Spine. The Orthopaedics and Spine segment specializes in implants for hip and knee joint replacements, trauma, and extremities surgeries, as well as spinal implant products. The MedSurg and Neurotechnology segment provides a range of medical devices and products for various medical specialties, including surgical equipment, navigation systems, emergency medical equipment, and neurotechnology products for minimally invasive endovascular techniques and brain surgeries. Stryker Corporation (NYSE:SYK) is one of the best robotics stocks to invest in.

On January 30, Stryker Corporation (NYSE:SYK) reported a Q4 non-GAAP EPS of $3.46 and a revenue of $5.8 billion, outperforming $0.19 and $200 million, respectively. Terry Smith’s Fundsmith LLP is the leading stakeholder of the company, with 5.5 million shares worth $1.5 billion.

Baron Health Care Fund stated the following regarding Stryker Corporation (NYSE:SYK) in its fourth quarter 2023 investor letter:

“We initiated a position in Stryker Corporation (NYSE:SYK) during the quarter. Stryker is a large diversified medical device company with two business segments: (1) MedSurg and Neurotechnology, and (2) Orthopedics and Spine. The stock sold off during the quarter along with many other medical device stocks because of concerns about the impact of GLP-1 weight loss medicines on their business (lol). Specific to Stryker, the concern was that weight loss would reduce demand for hip and knee implant procedures because obesity is one factor that drives osteoarthritis. We think this concern was overstated and saw the sell-off as an opportunity to buy a high-quality growth company at a reasonable valuation. We think Stryker is well positioned with its broad product portfolio to benefit from the trend of more orthopedic and other medical procedures moving from the hospital to ambulatory surgery centers. The company also has several new product launches coming up that should drive growth. At its recent Investor Day, management provided long-term financial goals including organic sales growth at the high end of the medical technology industry and double-digit EPS growth.”

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>>> Why Shares in GE HealthCare Technologies Soared in December


Motley Fool

By Lee Samaha

Jan 5, 2024


https://www.fool.com/investing/2024/01/05/why-shares-in-ge-healthcare-technologies-soared-in/


KEY POINTS

Management's plans to expand profit margins were boosted by its ongoing success at launching new products.

The stock remains an excellent option for investors looking for healthcare exposure in their portfolio.

New product introductions encourage investors to believe this healthcare stock is headed for greatness.

Shares in healthcare technology company GE Healthcare (GEHC) rose by an impressive 12.9% in December, according to data provided by S&P Global Market Intelligence.

While cyclical companies did very well in December due to lower market interest rates, GE Healthcare's outperformance comes down to stock-specific news relating to its key earnings driver. In other words, management aims to improve its profit margins while growing revenue at a mid-single-digit rate.

How GE Healthcare plans to expand profit margins

Following the spin-off from General Electric in early 2023, management has taken many routes to expand profitability. They include taking a more focused approach to pricing and "product platforming" (developing products that work off a common platform), investing in products powered by artificial intelligence (AI), and enhancing its software mix.

In addition, GE Healthcare has a significant opportunity in the growing field of theranostics (using agents to deliver drugs to precise areas), not least because it manufactures the agents used to diagnose, monitor, and guide drug delivery and the high-ticket imaging equipment.

New product introductions

However, I digress. The key to the move in December is probably the biggest driver of GE Healthcare's long-term margin expansion and growth plans, namely new product introductions (NPI). NPIs not only drive demand growth but also tend to come with higher margins. GE Healthcare released 40 NPI at the Radiological Society of North America (RSNA) annual meeting in 2022, and it was a similar story recently, with more than 40 products released at RNSA in late November 2023.

These included theranostics tools, AI, and deep learning solutions, including AI-enabled ultrasound solutions, imaging technology, and scanners.

By keeping up the constant pace of NPI launches, GE Healthcare can take full advantage of its new-found independence from GE and improve profitability and cash-flow generation from earnings.

A stock to buy for 2024?

NPI growth is essential because GE Healthcare suffered margin erosion in making investments to generate them in 2023. Still, the company is on track to expand its comparable earnings before interest and taxes (EBIT) margin from 14.5% in 2022 to 15%-15.5% in 2023. Management believes it can hit a high-teens to 20% EBIT margin over the medium term.

As such, GE Healthcare remains an excellent option for investors looking for a high-quality healthcare stock with solid top-line growth prospects married with margin expansion and profit growth.

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>>> GE HealthCare Technologies Inc. (GEHC) engages in the development, manufacture, and marketing of products, services, and complementary digital solutions used in the diagnosis, treatment, and monitoring of patients in the United States, Canada, and internationally. The company operates through four segments: Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics.

The Imaging segment offers molecular imaging, computed tomography (CT) scanning, magnetic resonance (MR) imaging, image-guided therapy, X-ray systems, and women's health products.

The Ultrasound segment provides medical devices and solutions for screening, diagnosis, treatment, and monitoring of certain diseases in clinical areas, such as radiology and primary care, women's health, cardiovascular, and point of care and handheld ultrasound solutions, as well as surgical visualization and guidance products.

The Patient Care Solutions segment provides medical devices, consumables, services, and digital solutions. Its portfolio includes patient monitoring solutions, anesthesia delivery and respiratory care products, electrocardiogram solutions, maternal infant care products, and consumables and services.

The Pharmaceutical Diagnostics supplies diagnostic agents, including CT, angiography and X-ray, MR, single-photon emission computed tomography, positron emission tomography, and ultrasound to the radiology and nuclear medicine industry. The segment also provides contrast media pharmaceuticals that are administered to a patient prior to certain diagnostic scans to increase the visibility of tissues or structures during imaging exams; and molecular imaging agents or radiopharmaceuticals, which are molecular tracers labeled with radioisotopes.

The company was formerly known as GE Healthcare Holding LLC and changed its name to GE HealthCare Technologies Inc. in December 2022. The company was incorporated in 2022 and is headquartered in Chicago, Illinois.

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https://finance.yahoo.com/quote/GEHC/profile


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>>> A brain pacemaker helped a woman with crippling depression. It may soon be available to more people


Associated Press

By LAURA UNGAR


https://www.msn.com/en-us/health/other/a-pacemaker-for-the-brain-helped-a-woman-with-crippling-depression-it-may-soon-be-available-to-more/ar-BB1iCRSi?OCID=ansmsnnews11


NEW YORK (AP) — Emily Hollenbeck lived with a deep, recurring depression she likened to a black hole, where gravity felt so strong and her limbs so heavy she could barely move. She knew the illness could kill her. Both of her parents had taken their lives.

She was willing to try something extreme: Having electrodes implanted in her brain as part of an experimental therapy.

Researchers say the treatment —- called deep brain stimulation, or DBS — could eventually help many of the nearly 3 million Americans like her with depression that resists other treatments. It's approved for conditions such as Parkinson's disease and epilepsy, and many doctors and patients hope it will become more widely available for depression soon.

The treatment gives patients targeted electrical impulses, much like a pacemaker for the brain. A growing body of recent research is promising, with more underway — although two large studies that showed no advantage to using DBS for depression temporarily halted progress, and some scientists continue to raise concerns.

Meanwhile, the Food and Drug Administration has agreed to speed up its review of Abbott Laboratories' request to use its DBS devices for treatment-resistant depression.

“At first I was blown away because the concept of it seems so intense. Like, it’s brain surgery. You have wires embedded in your brain,” said Hollenbeck, who is part of ongoing research at Mount Sinai West. “But I also felt like at that point I tried everything, and I was desperate for an answer.”

“NOTHING ELSE WAS WORKING”

Hollenbeck suffered from depression symptoms as a child growing up in poverty and occasional homelessness. But her first major bout happened in college, after her father’s suicide in 2009. Another hit during a Teach for America stint, leaving her almost immobilized and worried she’d lose her classroom job and sink into poverty again. She landed in the hospital.

“I ended up having sort of an on-and-off pattern,” she said. After responding to medication for a while, she'd relapse.

She managed to earn a doctorate in psychology, even after losing her mom in her last year of grad school. But the black hole always returned to pull her in. At times, she said, she thought about ending her life.

She said she'd exhausted all options, including electroconvulsive therapy, when a doctor told her about DBS three years ago.

“Nothing else was working,” she said.

She became one of only a few hundred treated with DBS for depression.

Hollenbeck had the brain surgery while sedated but awake. Dr. Brian Kopell, who directs Mount Sinai's Center for Neuromodulation, placed thin metal electrodes in a region of her brain called the subcallosal cingulate cortex, which regulates emotional behavior and is involved in feelings of sadness.

The electrodes are connected by an internal wire to a device placed under the skin in her chest, which controls the amount of electrical stimulation and delivers constant low-voltage pulses. Hollenbeck calls it “continuous Prozac.”

Doctors say the stimulation helps because electricity speaks the brain’s language. Neurons communicate using electrical and chemical signals.

In normal brains, Kopell said, electrical activity reverberates unimpeded in all areas, in a sort of dance. In depression, the dancers get stuck within the brain’s emotional circuitry. DBS seems to “unstick the circuit,” he said, allowing the brain to do what it normally would.

Hollenbeck said the effect was almost immediate.

“The first day after surgery, she started feeling a lifting of that negative mood, of the heaviness,” said her psychiatrist, Dr. Martijn Figee. “I remember her telling me that she was able to enjoy Vietnamese takeout for the first time in years and really taste the food. She started to decorate her home, which had been completely empty since she moved to New York.”

For Hollenbeck, the most profound change was finding pleasure in music again.

“When I was depressed, I couldn’t listen to music. It sounded and felt like I was listening to radio static,” she said. “Then on a sunny day in the summer, I was walking down the street listening to a song. I just felt this buoyancy, this, ‘Oh, I want to walk more, I want to go and do things!’ And I realized I’m getting better.”

She only wishes the therapy had been there for her parents.

THE TREATMENT'S HISTORY

The road to this treatment stretches back two decades, when neurologist Dr. Helen Mayberg led promising early research.

But setbacks followed. Large studies launched more than a dozen years ago showed no significant difference in response rates for treated and untreated groups. Dr. Katherine Scangos, a psychiatrist at the University of California, San Francisco, also researching DBS and depression, cited a couple of reasons: The treatment wasn’t personalized, and researchers looked at outcomes over a matter of weeks.

Some later research showed depression patients had stable, long-term relief from DBS when observed over years. Overall, across different brain targets, DBS for depression is associated with average response rates of 60%, one 2022 study said.

Treatments being tested by various teams are much more tailored to individuals today. Mount Sinai's team is one of the most prominent researching DBS for depression in the U.S. There, a neuroimaging expert uses brain images to locate the exact spot for Kopell to place electrodes.

“We have a template, a blueprint of exactly where we’re going to go,” said Mayberg, a pioneer in DBS research and founding director of The Nash Family Center for Advanced Circuit Therapeutics at Mount Sinai. “Everybody’s brain is a little different, just like people’s eyes are a little further apart or a nose is a little bigger or smaller.”

Other research teams also tailor treatment to patients, although their methods are slightly different. Scangos and her colleagues are studying various targets in the brain and delivering stimulation only when needed for severe symptoms. She said the best therapy may end up being a combination of approaches.

As teams keep working, Abbott is launching a big clinical trial this year, ahead of a potential FDA decision.

“The field is advancing quite quickly,” Scangos said. “I’m hoping we will have approval within a short time.”

But some doctors are skeptical, pointing to potential complications such as bleeding, stroke or infection after surgery.

Dr. Stanley Caroff, an emeritus professor of psychiatry at the University of Pennsylvania, said scientists still don't know the exact pathways or mechanisms in the brain that produce depression, which is why it's hard to pick a site to stimulate. It's also tough to select the right patients for DBS, he said, and approved, successful treatments for depression are available.

“I believe from a psychiatric point of view, the science is not there,” he said of DBS for depression.

MOVING FORWARD

Hollenbeck acknowledges DBS hasn't been a cure-all; she still takes medicines for depression and needs ongoing care.

She recently visited Mayberg in her office and discussed recovery. “It’s not about being happy all the time,” the doctor told her. “It’s about making progress.”

That’s what researchers are studying now — how to track progress.

Recent research by Mayberg and others in the journal Nature showed it’s possible to provide a “readout” of how someone is doing at any given time. Analyzing the brain activity of DBS patients, researchers found a unique pattern that reflects the recovery process. This gives them an objective way to observe how people get better and distinguish between impending depression and typical mood fluctuations.

Scientists are confirming those findings using newer DBS devices in a group of patients that includes Hollenbeck.

She and other participants do their part largely at home. She gives researchers regular brain recordings by logging onto a tablet, putting a remote above the pacemaker-like device in her chest and sending the data. She answers questions that pop up about how she feels. Then she records a video that will be analyzed for things such as facial expression and speech.

Occasionally, she goes into Mount Sinai’s “Q-Lab,” an immersive environment where scientists do quantitative research collecting all sorts of data, including how she moves in a virtual forest or makes circles in the air with her arms. Like many other patients, she moves her arms faster now that she’s doing better.

Data from recordings and visits are combined with other information, such as life events, to chart how she's doing. This helps guide doctors’ decisions, such as whether to increase her dose of electricity – which they did once.

On a recent morning, Hollenbeck moved her collar and brushed her hair aside to reveal scars on her chest and head from her DBS surgery. To her, they're signs of how far she’s come.

She makes her way around the city, taking walks in the park and going to libraries, which were a refuge in childhood. She no longer worries that normal life challenges will trigger a crushing depression.

“The stress is pretty extreme at times, but I’m able to see and remember, even on a bodily level, that I’m going to be OK,” she said.

“If I hadn’t had DBS, I’m pretty sure I would not be alive today.”

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>>> Zombie deer disease is spreading and scientists are concerned that it could jump to humans


Phys.org

by Samuel J. White, Philippe B. Wilson

2-19-24


https://www.msn.com/en-us/health/other/zombie-deer-disease-is-spreading-and-scientists-are-concerned-that-it-could-jump-to-humans/ar-BB1ix3R3?OCID=ansmsnnews11


In the tranquil expanses of North America's woodlands and grasslands, a silent but concerning phenomenon is unfolding: chronic wasting disease (CWD). The condition, often dubbed "zombie deer disease", is stealthily spreading among deer populations, sparking concerns among scientists, conservationists and the public alike.

This neurological affliction, characterized by myriad symptoms, such as drooling, lethargy, stumbling and a vacant gaze, has now been detected in over 800 samples of deer, elk and moose in Wyoming alone, highlighting the scale and urgency of the issue.

At the heart of the CWD puzzle lies a peculiar culprit: prions.

Prions are misfolded proteins that can cause normal proteins in the brain to misfold as well, leading to neurological degeneration. This unique feature makes prion diseases particularly concerning as they are notoriously resilient and can persist in the environment for years, resisting traditional disinfection methods such as formaldehyde, radiation and incineration at extreme temperatures.

The spread of CWD poses significant ecological and potentially human health risks. While there is no conclusive evidence that CWD can directly infect humans, the possibility remains a point of concern.

Prion diseases, such as Creutzfeldt-Jakob disease (CJD) in humans and "mad cow disease" in cattle, have shown that they can cross the species barrier—with devastating consequences. The outbreak of mad cow disease in Britain, for instance, resulted in the slaughter of millions of cattle and led to 178 human deaths attributed to the human variant of the disease since 1995.

Despite the lack of confirmed cases of CWD in humans, concerns persist due to several factors. First, studies have shown that prions responsible for CWD can infect and propagate within human cells under laboratory conditions, raising the specter of potential transmission.

Second, humans are already inadvertently exposed to potentially infected animals by hunting and eating them. Reports suggest that between 7,000 to 15,000 CWD-infected animals were consumed annually by humans in 2017, with projections indicating a 20% annual increase.

In regions where CWD prevalence is high, such as Wisconsin, thousands of people may have unwittingly consumed meat from infected deer, underscoring the urgency for measures to mitigate risks.

Also, the inherent difficulties associated with detecting and diagnosing prion diseases in humans further complicate the situation. Unlike conventional infectious agents, prions do not trigger an immune response, making them difficult to detect through conventional means. This poses a significant obstacle to early intervention and containment efforts.

The potential for CWD to affect human health is not limited to direct transmission. The environmental persistence of prions means that humans may also be exposed through indirect routes, such as contaminated soil, water and other environmental sources. Given the resilience of prions and their ability to persist in the environment for extended periods, the long-term consequences of CWD on human health remain uncertain but warrant serious consideration.

Beyond the immediate health concerns, the spread of CWD also poses significant ecological and economic risks. Deer hunting is not only a popular recreational activity but also a vital source of sustenance and livelihood for many communities. The proliferation of CWD threatens to disrupt this delicate balance, potentially decimating deer populations and compromising food security in affected regions.

Furthermore, the ecological effects of CWD extend beyond deer populations, affecting entire ecosystems. Deer play a crucial role in shaping vegetation dynamics (how plant communities change and evolve over time) through browsing and grazing. And their decline could have cascading effects on plant communities, soil health and other wildlife species that depend on deer as a food source or habitat modifier.

In Europe too

It is noteworthy that while there have been no outbreaks of CWD in the UK, in 2016 it was diagnosed in wild deer in Norway, marking the first cases of CWD in Europe. This development underscores the potential for CWD to spread beyond its current range and highlights the need for international cooperation in monitoring and controlling the disease.

Addressing the many challenges posed by CWD requires a comprehensive and coordinated approach. This includes bolstering surveillance and monitoring to track the spread of the disease, and implementing stringent biosecurity measures to prevent further transmission—such as controlling the movement of deer and elk populations, conducting regular testing to monitor disease prevalence, and promoting responsible hunting practices to minimize the risk of transmission.

More research is also needed to better understand the disease's transmission dynamics, its ecological effects and potential human health implications.

Ultimately, the specter of CWD underscores the interconnectedness of ecosystems and human health. By heeding the warnings of scientists and taking decisive action to mitigate risks, we can strive to protect both wildlife and human populations from the insidious grip of CWD and other emerging zoonotic diseases. In doing so, we honor our commitment to safeguarding the health and well-being of our planet and its inhabitants for generations to come.

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Iovance - >>> FDA approves groundbreaking treatment for advanced melanoma


NBC News

by Erika Edwards and Anne Thompson and Marina Kopf

2-16-24


https://www.msn.com/en-us/health/other/fda-approves-groundbreaking-treatment-for-advanced-melanoma/ar-BB1ioIYQ?OCID=ansmsnnews11


The Food and Drug Administration on Friday approved a new cancer therapy that could one day transform the way a majority of aggressive and advanced tumors are treated.

The treatment, called Amtagvi, from Iovance Biotherapeutics, is for metastatic melanoma patients who have already tried and failed other drugs. It’s known as TIL therapy and involves boosting the number of immune cells inside tumors, harnessing their power to fight the cancer.

It’s the first time a cellular therapy has been approved to treat solid tumors. The drug was given a fast-track approval based on the results of a phase 2 clinical trial. The company is conducting a larger phase 3 trial to confirm the treatment’s benefits.

“This is going to be huge,” said Dr. Elizabeth Buchbinder, a senior physician at Dana-Farber Cancer Institute in Boston. Melanoma is “not one of those cancers where there’s like 20 different” possible treatments, she said. “You start running out of options fast.”

Friday’s approval is only for melanoma, the deadliest form of skin cancer, but experts say it holds promise for treating other solid tumors, which account for 90% of all cancers.

“It is our hope that future iterations of TIL therapy will be important for lung cancer, colon cancer, head and neck cancer, bladder cancer and many other cancer types,” said Dr. Patrick Hwu, chief executive of the Moffitt Cancer Center in Tampa, Florida. Moffitt has been involved with Iovance’s clinical trials of TIL therapy.

TIL stands for tumor-infiltrating lymphocytes, which are immune cells that exist within tumors. But there are nowhere nearly enough of those cells to effectively fight off cancer cells. TIL therapy involves, in part, extracting some of those immune cells from the patient’s tumor and replicating them billions of times in a lab, then reinfusing them back into the patient.

It’s similar to CAR-T cell therapy, where healthy cells are taken out of a person’s body and then modified in a lab to fight cancers. That’s usually used for hard-to-treat blood cancers such as leukemia and lymphoma. With TIL therapy, the cells used are already programmed to recognize cancer — no lab modifications needed — they just need a boost in numbers to fight it.

Like CAR-T, TIL therapy is a one-time treatment, though the entire process can take up to eight weeks. The TIL cells are first harvested from the tumor through a minimally invasive procedure and then grown and multiplied in the lab, a process that takes 22 days, according to Iovance.

While that’s happening, patients are given chemotherapy to clear out their immune cells to make room for the billions of new melanoma-fighting TIL cells. Once the TIL cells are reinfused back into the body, patients get a drug called interleukin-2 to further stimulate those cells.

Hwu said that most side effects in patients undergoing TIL therapy are not from the reinfusion of cells, but from the chemotherapy and the interleukin-2. These can include nausea and extreme fatigue, and patients are also vulnerable to other illnesses because the body is depleted of disease-fighting white blood cells.

Putting billions of cells back into the body is not entirely risk-free, however, said Dr. William Dahut, chief scientific officer of the American Cancer Society. It’s possible that the body’s immune system could overreact in what’s known as a cytokine storm, which can cause flu-like symptoms, low blood pressure and organ damage. “There are risks for immune-related side effects, which could be serious,” he said.

Common side effects associated with Amtagvi can include abnormally fast heart rate, fluid buildup, rash, hair loss and feeling short of breath, the FDA said.

Those side effects can be managed, said Dr. Steven Rosenberg, chief of the surgery branch at the National Cancer Institute. “They’re a small price to pay for a growing cancer that would otherwise be be lethal.”

Overall, Dahut said the approval of TIL therapy is “meaningful.”

“What’s nice about this is that patients will receive a wide variety of tumor fighting lymphocytes that will be able to have the capacity to overcome resistance and actually be a living therapy over time, too, to target additional cancer cells should they develop,” Dahut said.

In addition to melanoma, Dahut said that TIL therapy is most likely to be useful in cancers that respond to drugs that “take the brakes off the immune system,” called checkpoint inhibitors.

“Those would be things like non-small cell lung cancer, kidney cancer, maybe bladder cancer, that we know are responsive to immune-based therapies to begin with,” he said. “Many of those patients relapse, so another immune-based therapy that works in a different way, seems to me, the most likely way for this to be effective.”

Much more research is needed, and it may be years before TIL therapy is approved for other types of cancer.

One of Iovance’s clinical trials investigating TIL therapy for non-small cell lung cancer was forced to pause when a participant died. While the death is under investigation, the company said it may have been the result of either chemotherapy or interleukin 2 — therapies meant to knock down each patients’ immune system before they can get the reinfusion of their TIL cells.

The therapy is not expected to work for every metastatic melanoma patient. Clinical trial data that Iovance submitted to the FDA showed that tumors shrank in about a third of patients who received TIL therapy.

Of those patients, about half saw their tumors shrink for at least one year, Dr. Friedrich Graf Finckenstein, chief medical officer of Iovance Biotherapeutics. “Some of these patients even had their tumor completely disappear,” he said.

Another study, conducted in the Netherlands, did a head-to-head analysis of TIL therapy and another form of immunotherapy, called ipilimumab. Twenty percent of the patients who received TIL had complete remissions, compared with 7% of patients who got ipilimumab. Iovance was not involved with the Dutch trial.

The goal of the therapy, Hwu said, “is to get rid of the cancer and have it stay away. These immune cells stay in the body and live in the body for decades.”

The technology has been in development and studied for nearly 40 years. It was Rosenberg who pioneered TIL therapy — first describing how it could shrink melanoma tumors in the New England Journal of Medicine in 1988.

“I’ve been waiting for a very long time to see this given to patients, because I know that it can cure some patients that have metastatic melanoma that cannot be affected by any other treatment,” Rosenberg said.

It’s worked so far for Dan Bennett, 59, of Clermont, Florida. Bennett was diagnosed with melanoma in 2011 after his daughter noticed a suspicious mole on his neck that had changed color.

Despite surgery, chemotherapy and radiation, his cancer kept returning. In 2014, his doctors at Moffitt recommended he try TIL therapy.

“At first, we were pretty leery about it because it was unproven,” Bennett said. Ten years later, Bennett is convinced the TIL therapy is the reason he has survived so long with stage 4 melanoma, which usually has a five-year survival rate of 22.5%.

“I would recommend any experimental drug if it’s your last opportunity,” he said. “You owe it to yourself and your family to do whatever you can to stay alive and to be a productive member of society.”

Buchbinder, the Dana-Faber doctor, was not involved with Iovance’s TIL therapy trial for melanoma, but she is scheduled to begin similar trials with other drugmakers.

“We literally have patients right now waiting for approval because they are hoping they’ll be able to go on it,” Buchbinder said. “It is definitely a practice-changing therapy.”

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>>> Medpace Holdings Inc (MEDP) Reports Robust Revenue Growth and Solid Earnings in Q4 and Full ...


GuruFocus Research

Feb 12, 2024


https://finance.yahoo.com/news/medpace-holdings-inc-medp-reports-213433201.html


Revenue Growth: Q4 revenue increased by 26.5% to $498.4 million, and full-year revenue jumped by 29.2% to $1.885.8 million.

Net Income: Q4 GAAP net income rose to $78.3 million, with a net income margin of 15.7%. Full-year net income reached $282.8 million.

Earnings Per Share: Diluted EPS for Q4 was $2.46, up from $2.12 in the prior-year period. Full-year diluted EPS increased to $8.88.

EBITDA: Q4 EBITDA grew by 19.2% to $95.8 million, representing an EBITDA margin of 19.2%. Full-year EBITDA was $362.5 million.

Backlog and Book-to-Bill Ratio: Backlog as of December 31, 2023, increased by 20.2% to $2.813.0 million, with a net book-to-bill ratio of 1.23x for Q4.

2024 Financial Guidance: Medpace forecasts 2024 revenue in the range of $2.150 billion to $2.200 billion, with GAAP net income expected between $326.0 million and $348.0 million.

Liquidity and Share Repurchase: Cash and cash equivalents stood at $245.4 million, and the company repurchased 781,068 shares for $144.0 million in 2023.

On February 12, 2024, Medpace Holdings Inc (NASDAQ:MEDP) released its 8-K filing, announcing its financial results for the fourth quarter and full year ended December 31, 2023. The late-stage contract research organization, known for its full-service drug development and clinical trial services, reported significant revenue growth and an increase in net income, reflecting a strong performance in a competitive industry.

Financial Performance Highlights

Medpace's revenue for Q4 2023 reached $498.4 million, a 26.5% increase from the $394.1 million reported in the same period last year. This growth was attributed to a backlog conversion rate of 18.5%. The full-year revenue also saw a substantial rise, with a 29.2% increase to $1.885.8 million compared to the previous year. The company's net new business awards for Q4 were $614.7 million, marking a 26.7% increase from the prior-year period and resulting in a net book-to-bill ratio of 1.23x.

GAAP net income for Q4 was $78.3 million, or $2.46 per diluted share, compared to $68.7 million, or $2.12 per diluted share, for the same quarter in the previous year. The net income margin slightly decreased to 15.7% from 17.4% in Q4 2022. For the full year, GAAP net income was $282.8 million, or $8.88 per diluted share, up from $245.4 million, or $7.28 per diluted share, in 2022.

EBITDA for Q4 2023 increased by 19.2% to $95.8 million, representing an EBITDA margin of 19.2%. The full-year EBITDA also grew by 17.7% to $362.5 million. These financial achievements underscore Medpace's ability to efficiently manage its operations and maintain profitability in the Medical Diagnostics & Research industry.

Operational and Strategic Developments

Medpace's operational efficiency is reflected in its direct costs and SG&A expenses. For Q4 2023, total direct costs were $361.6 million, and SG&A expenses were $42.5 million. The company's balance sheet remains strong, with cash and cash equivalents of $245.4 million as of December 31, 2023. Medpace generated $156.4 million in cash flow from operating activities during Q4 2023 and repurchased 781,068 shares for $144.0 million throughout the year.

Looking ahead, Medpace provided its 2024 financial guidance, forecasting revenue in the range of $2.150 billion to $2.200 billion, which would represent a growth of 14.0% to 16.7% over 2023 revenue. The company also anticipates GAAP net income for the full year 2024 to be between $326.0 million and $348.0 million, with EBITDA expected in the range of $400.0 million to $430.0 million.

Medpace's continued investment in its global infrastructure and its disciplined approach to clinical development have positioned the company for sustained growth. With a strong financial foundation and a clear strategic direction, Medpace is well-equipped to navigate the dynamic landscape of the biotechnology, pharmaceutical, and medical device industries.

For more detailed information on Medpace Holdings Inc's financial results, investors and interested parties are encouraged to review the full 8-K filing.

Explore the complete 8-K earnings release (here) from Medpace Holdings Inc for further details.

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>>> FDA says 561 deaths tied to recalled Philips sleep apnea machines


CBS News

by Kate Gibson

February 1, 2024


https://finance.yahoo.com/news/fda-says-561-deaths-tied-144358824.html


The Food and Drug Administration says 561 deaths have been reported in connection to recalled Philips devices to treat obstructive sleep apnea and other breathing disorders.

The FDA said that since April 2021 it has received more than 116,000 medical device reports of foam breaking down in Philips CPAP (continuous positive airway pressure) machines and BiPAP sleep therapy devices. That includes 561 reports of death, the agency said Wednesday.

The Dutch medical device maker has recalled millions of the breathing machines amid reports they were blowing gas and pieces of foam into the airways of those using the devices.

Polyester-based polyurethane foam used in the devices to reduce sound and vibration can break down, with black pieces of foam or invisible chemicals that can be breathed in or swallowed by the person using the device. "These issues could potentially result in serious injury and require medical intervention to prevent permanent injury," the FDA stated.

The grim tally comes days after Philips said it would stop selling the machines in the U.S. in a settlement with the FDA and the Justice Department expected to cost roughly $400 million, the company disclosed in a regulatory filing.

The tentative agreement, which must be approved by a U.S. court, calls for the company to keep servicing apnea machines already being used while stopping to sell new ones until specific conditions are met.

After an initial recall announced in June of 2021 to repair or replace about 5.5 million globally, Philips then had to recall a limited number of ventilators after they'd been repaired, according to the company.

Philips in late 2023 agreed to pay at least $479 million to compensate users of 20 different breathing devices and ventilators sold in the U.S. between 2008 and 2021. Claims for financial losses related to the purchase, lease or rent of the recalled machines can be now be lodged in the wake of a proposed class-action settlement reached in September.

Claims for financial losses related to the purchase, lease or rent of the recalled devices can be made, with eligible users entitled to:

a Device Payment Award for each recalled device purchased, leased or rented;a Device Return Award of $100 for each recalled device returned by Aug. 9, 2024; and/ora Device Replacement Award for money spent to buy a comparable machine on or after June 14, 2021 and before Sept. 7, 2023 to replace a recalled device.How to file a claim

To determine whether one is eligible and for instructions on what steps, if any, are needed to receive a payment, the settlement administrator has set up in interactive website here.

Users can look up their recalled device's serial number to see what device payment award they may be entitled to by clicking here.

Those who return a recalled Philips machine by the August deadline are entitled to both the return and payment awards without having to submit a claim form and can use prepaid shipping labels by clicking here at no cost.

Those who spent their own money buying a comparable replacement CPAP or ventilator to replace a recalled device will need to complete a device replacement claim form, which can be found here. A paper device replacement form can also be found here or by calling 1-855-912-3432.

The deadline for claim submissions is Aug. 9, 2024.

The settlement does not impact or release any claims for personal injuries or medical monitoring relief, according to the administrator with the U.S. District Court for the Western District of Pennsylvania.

Roughly 30 million people have sleep apnea, a disorder in which one's airways become blocked during rest, interrupting breathing, according to 2022 data from the American Medical Association.

The company investigated all complaints and allegations of malfunction and serious injury of death, and "has found no conclusive data linking these devices and the deaths reported, Philips told CBS MoneyWatch on Thursday.

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>>> Maker of recalled sleep apnea machines agrees to halt sales in US


AP

by MATTHEW PERRONE

January 29, 2024


https://finance.yahoo.com/news/maker-millions-recalled-sleep-apnea-190454561.html


WASHINGTON (AP) — The company behind a global recall of sleep apnea machines said Monday it will stop selling the devices in the U.S., under a tentative agreement with regulators that could cost the manufacturer nearly $400 million.

Device maker Philips has recalled more than 5 million pressurized breathing machines due to risks that their internal foam can break down over time, leading users to inhale tiny particles and fumes while they sleep.

The company first announced the problem in mid-2021, but efforts to repair or replace the machines have dragged on for years, frustrating patients in the U.S. and other countries.

The Dutch manufacturing giant said it has agreed to a consent decree with the Food and Drug Administration and the Department of Justice. The deal has not yet been finalized and will have to be approved by a U.S. judge. Philips executives disclosed the tentative agreement during a quarterly earnings update.

Under the agreement's terms, Philips would continue servicing previously sold machines in the U.S., but couldn't sell new ones until it meets corrective actions laid out by the FDA. Company executives said they have set aside $393 million for operational changes and upgrades needed to comply.

The company promised it would put "safety and quality at the center of everything we do with a greater level of accountability,” Philips CEO Roy Jakobs told analysts and investors.

The FDA's website warns patients that the risks of ingesting the sound-dampening foam could include headache, asthma, allergic reactions and more serious problems. In November, the agency issued a new warning that the machines can overheat, in rare cases causing fires.

The agency said it cannot comment on Philips' announcement until a final agreement is “signed and filed with the court.”

In 2022, the FDA took the rare step of ordering Philips to step up its outreach to customers about the recall including “clearer information about the health risks of its products.” At the time, the agency estimated only about half the people in the U.S. with affected machines knew they had been recalled.

Customers trying to obtain refunds or new or refurbished devices from the company have reported months of delays.

Most of the recalled devices are continuous positive airway pressure, or CPAP, machines. They force air through a mask to keep passageways open during sleep. The company has also recalled certain lines of ventilators and other breathing devices.

Untreated sleep apnea can cause people to stop breathing hundreds of times per night, leading to dangerous drowsiness and increased heart attack risk. The problem is more common in men than women, with estimates ranging from 10% to 30% of adults affected.

On Monday, Philips again pointed to company-commissioned studies suggesting that inhaling foam from its machines is “unlikely to result in appreciable harm” to patients. The company has discontinued several of the recalled models.

The latest announcement does not resolve 675 personal injury lawsuits filed against the company over the devices. Those cases have been consolidated in a federal court in Pennsylvania.

Philips faces similar legal challenges in Canada, Australia, Israel and Chile, according to the company's update.

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>>> Eli Lilly and Company (LLY) discovers, develops, and markets human pharmaceuticals worldwide. It offers Basaglar, Humalog, Humalog Mix 75/25, Humalog U-100, Humalog U-200, Humalog Mix 50/50, insulin lispro, insulin lispro protamine, insulin lispro mix 75/25, Humulin, Humulin 70/30, Humulin N, Humulin R, and Humulin U-500 for diabetes; and Jardiance, Trajenta, and Trulicity for type 2 diabetes. The company provides Alimta for non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma; Cyramza for metastatic gastric cancer, gastro-esophageal junction adenocarcinoma, metastatic NSCLC, metastatic colorectal cancer, and hepatocellular carcinoma; Erbitux for colorectal cancers, and various head and neck cancers; Retevmo for metastatic NSCLC, medullary thyroid cancer, and thyroid cancer; Tyvyt for relapsed or refractory classic Hodgkin's lymph and non-squamous NSCLC; and Verzenio for HR+, HER2- metastatic breast cancer, node positive, and early breast cancer. It offers Olumiant for rheumatoid arthritis; and Taltz for plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondylarthritis. The company offers Cymbalta for depressive disorder, diabetic peripheral neuropathic pain, generalized anxiety disorder, fibromyalgia, and chronic musculoskeletal pain; Emgality for migraine prevention and episodic cluster headache; and Zyprexa for schizophrenia, bipolar I disorder, and bipolar maintenance. Its Bamlanivimab and etesevimab, and Bebtelovimab for COVID-19; Cialis for erectile dysfunction and benign prostatic hyperplasia; and Forteo for osteoporosis.

The company has collaborations with Incyte Corporation; Boehringer Ingelheim Pharmaceuticals, Inc.; AbCellera Biologics Inc.; Junshi Biosciences; Regor Therapeutics Group; Lycia Therapeutics, Inc.; Kumquat Biosciences Inc.; Entos Pharmaceuticals Inc.; Foghorn Therapeutics Inc., and PRISM BioLab Co.,Ltd. Eli Lilly and Company was founded in 1876 and is headquartered in Indianapolis, Indiana.

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https://finance.yahoo.com/quote/LLY/profile?p=LLY


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>>> Stryker Corporation (SYK) operates as a medical technology company. The company operates through two segments, MedSurg and Neurotechnology, and Orthopaedics and Spine.

The Orthopaedics and Spine segment provides implants for use in hip and knee joint replacements, and trauma and extremities surgeries. This segment also offers spinal implant products comprising cervical, thoracolumbar, and interbody systems that are used in spinal injury, deformity, and degenerative therapies.

The MedSurg and Neurotechnology segment offers surgical equipment and surgical navigation systems, endoscopic and communications systems, patient handling, emergency medical equipment and intensive care disposable products, reprocessed and remanufactured medical devices, and other medical device products that are used in various medical specialties. This segment also provides neurotechnology products, which include products used for minimally invasive endovascular techniques; products for brain and open skull based surgical procedures; orthobiologic and biosurgery products, such as synthetic bone grafts and vertebral augmentation products; minimally invasive products for the treatment of acute ischemic and hemorrhagic stroke; and craniomaxillofacial implant products, including cranial, maxillofacial, and chest wall devices, as well as dural substitutes and sealants.

The company sells its products to doctors, hospitals, and other healthcare facilities through company-owned subsidiaries and branches, as well as third-party dealers and distributors in approximately 75 countries. Stryker Corporation was founded in 1941 and is headquartered in Kalamazoo, Michigan.

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https://finance.yahoo.com/quote/SYK/profile?p=SYK


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>>> Cencora, Inc. (COR) sources and distributes pharmaceutical products. The company's U.S. Healthcare Solutions segment distributes pharmaceuticals, over-the-counter healthcare products, home healthcare supplies and equipment, and related services to acute care hospitals and health systems, independent and chain retail pharmacies, mail order pharmacies, medical clinics, long-term care and alternate site pharmacies, and other customers; provides pharmacy management, staffing, and other consulting services; supply management software to retail and institutional healthcare providers; packaging solutions to various institutional and retail healthcare providers; clinical trial support, product post-approval, and commercialization support services; data analytics, outcomes research, and additional services for biotechnology and pharmaceutical manufacturers; pharmaceuticals, vaccines, parasiticides, diagnostics, micro feed ingredients, and other products to the companion animal and production animal markets; and sales force services to manufacturers. This segment also distributes plasma and other blood products, injectable pharmaceuticals, vaccines, and other specialty products; and provides other services to physicians who specialize in various disease states, such as oncology, as well as to other healthcare providers, including hospitals and dialysis clinics.

Its International Healthcare Solutions segment offers international pharmaceutical wholesale and related service, and global commercialization services; distributes pharmaceuticals, other healthcare products, and related services to pharmacies, doctors, health centers, and hospitals primarily in Europe; and provides specialty transportation and logistics services for the biopharmaceutical industry.

The company was formerly known as AmerisourceBergen Corporation and changed its name to Cencora, Inc. in August 2023. Cencora, Inc. was incorporated in 2001 and is headquartered in Conshohocken, Pennsylvania.

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https://finance.yahoo.com/quote/COR/profile?p=COR


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>>> Novo Nordisk A/S (NVO), a healthcare company, engages in the research, development, manufacture, and marketing of pharmaceutical products worldwide. It operates in two segments, Diabetes and Obesity care, and Rare Disease.

The Diabetes and Obesity care segment provides products in the areas of insulins, GLP-1 and related delivery systems, oral antidiabetic products, obesity, glucagon, needles, and other chronic diseases.

The Rare Disease segment offers products in the areas of haemophilia, blood disorders, endocrine disorders, growth disorders, and hormone replacement therapy.

The company has a collaboration agreement with Gilead Sciences, Inc.; and research collaboration with Novo Nordisk to discover cell-specific carriers of nucleic acid therapeutics. The company was founded in 1923 and is headquartered in Bagsvaerd, Denmark.

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https://finance.yahoo.com/quote/NVO/profile?p=NVO


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>>> Danaher completes $5.7 billion acquisition of Abcam


Reuters

Dec 6, 2023


https://finance.yahoo.com/news/1-danaher-completes-5-7-130903787.html


Dec 6 (Reuters) - Medical tools supplier Danaher said on Wednesday it has completed the $5.7 billion acquisition of Abcam, overcoming the initial opposition from the founder of the protein consumables maker.

Danaher agreed to buy Abcam in September for $24 per share to expand its portfolio of products and services, but founder Jonathan Milner opposed it saying the offer undervalued the company.

Milner, who owns a 6.14% stake, had said he would vote against the acquisition. But he later suspended his campaign after talks with shareholders, who said the company was fairly valued.

Abcam's shareholder voted in favour of the deal in November. Milner served as Abcam's CEO from 1999 to 2014 and later as deputy chairman from 2015 to 2020.

Cambridge, England-based Abcam manufactures and supplies so-called protein consumables such as antibodies and reagents used for medical research.

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>>> Danaher Corporation (DHR) Completed the Acquisition of Abcam


Insider Monkey

by Soumya Eswaran

Jan 19, 2024


https://finance.yahoo.com/news/danaher-corporation-dhr-completed-acquisition-092752759.html


Headwaters Capital Management, an investment management company, released its fourth-quarter 2023 investor letter. A copy of the same can be downloaded here. The fund increased by +18.1% (+17.1% net) in the fourth quarter compared to a +12.8% return for the Russell Mid Cap Index. For the full year, the fund returned +34.8% (+33.0% net) compared to a +17.2% return for the index. The extraordinary strength of the fourth quarter 2023 market returns was fueled by investor optimism that inflation is moderating and the Fed’s clear signal that rate cuts are expected to start in 2024. In addition, you can check the top 5 holdings of the fund to know its best picks in 2023.

Headwaters Capital Management featured stocks such as Danaher Corporation (NYSE:DHR) in the fourth quarter 2023 investor letter. Headquartered in Washington, the District of Columbia, Danaher Corporation (NYSE:DHR) designs, manufactures, and markets professional, medical, industrial, and commercial products and services. On January 18, 2024, Danaher Corporation (NYSE:DHR) stock closed at $226.31 per share. One-month return of Danaher Corporation (NYSE:DHR) was -1.76%, and its shares lost 6.95% of their value over the last 52 weeks. Danaher Corporation (NYSE:DHR) has a market capitalization of $167.227 billion.

Headwaters Capital Management stated the following regarding Danaher Corporation (NYSE:DHR) in its fourth quarter 2023 investor letter:

"Danaher Corporation's (NYSE:DHR) acquisition offer for ABCM was approved by shareholders on 11/6/23. Shareholders approved the deal based on trough fundamentals (potential China weakness) and trough valuation (the broader market bottomed on 10/27). DHR took advantage of broader market fears and mis-aligned management incentives to acquire Abcam at a cheap price. While disappointing, ABCM was still a very successful investment for Headwaters as it outperformed the market by +27% during our ownership. The cash received from the acquisition was immediately re-deployed into the newest addition to the portfolio, IPAR (discussed below)."

Danaher Corporation (NYSE:DHR) is in 21st position on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 103 hedge fund portfolios held Danaher Corporation (NYSE:DHR) at the end of third quarter which was 89 in the previous quarter.

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>>> Humana’s dire forecast shows private Medicare boom is ending


Bloomberg

by John Tozzi

January 26, 2024


https://finance.yahoo.com/news/humana-plunges-2024-forecast-misses-120703264.html


(Bloomberg) — Private Medicare plans that drove years of growth for US health insurers are getting less profitable and may cost seniors more money, Humana Inc.’s results showed, sending shares down across the sector.

The second-largest Medicare Advantage company, Humana struck a dire tone as it pulled its earnings guidance for 2025 and forecast 2024 profits short of analysts’ most pessimistic outlooks. The shares fell as much as 15% in New York, the most intraday since June.

As medical costs rise, Humana will have to raise prices and pull back on benefits to shore up profit margins, executives said Thursday on a conference call, and they expect competitors to do the same. If that happens, it may be the end of health insurers’ Medicare Advantage boom.

“The whole industry will possibly reprice” plans for next year, outgoing Chief Executive Officer Bruce Broussard said on a conference call. “I don’t know how the industry will take this kind of increase in utilization along with regulatory changes that will continue to persist in 2025 and 2026.”

Humana now sees adjusted earnings of approximately $16 a share in 2024, according to a statement Thursday. That would set its per-share profit back to a level not seen since 2018, shocking some analysts.

“We did not think $16 was possible,” Jefferies analyst David Windley wrote in a research note. From that level, Humana plans for growth of $6 to $10 a share in 2025.

Rivals have given different explanations for the jump in medical costs, adding uncertainty to the buffeted sector. UnitedHealth Group Inc., the largest seller of Medicare Advantage plans, told investors Jan. 12 that higher costs seen late last year were seasonal and wouldn’t persist through 2024. Elevance Health Inc., a smaller player in Medicare, indicated this week it had priced to cover rising costs.

Still, Humana’s forecast dragged on the sector. UnitedHealth fell as much as 6.6%, Cigna Group as much as 4.3%, CVS Health Corp. as much as 5.4% and Centene Corp. as much as 4.9%.

Worse than feared

More than half of US seniors on Medicare now get their benefits through private plans. Humana is more exposed to changes in the Medicare Advantage market than major competitors. Last week, a preview of fourth-quarter results showed accelerating medical expenses.

The US last year proposed new rates and other changes to restrict how insurers get paid. The government also finalized plans to claw back past overpayments, a policy Humana is challenging in court. Those changes are colliding with an uptick in costs as some patients resume seeking care they had deferred during the pandemic.

The changes to government billing are being phased in over three years starting in 2024, which means more pressure on the business is coming. The US is expected to announce its initial 2025 rate update for Medicare Advantage plans in the coming weeks.

Humana’s 2024 outlook assumes the higher medical costs that materialized in the fourth quarter will persist for the year. It’s a “wholesale rebasing of expectations” for the Medicare Advantage segment, RBC Capital Markets analyst Ben Hendrix wrote in a research note.

Humana executives said Thursday that they expect to remain focused on Medicare. The company was reported to be in talks with Cigna late last year to assemble a bigger, more diversified business, but discussions quickly fell apart.

“We do believe today being a specialty player in the fastest-growing part of the industry is the best value for the shareholders,” Broussard said.

Long-term questions

As recently as Nov. 1, Humana affirmed its 2025 profit target of $37 a share. Yet those expectations unraveled swiftly, even as risks to Medicare Advantage became clearer through 2023.

Rising cost trends took hold as insurers set prices for 2024 plans, and Humana told investors it considered their “initial emergence” in its pricing. Medical expenses jumped beyond what the company prepared for in late 2023, as Humana cited higher inpatient stays, doctor visits and outpatient surgeries.

The company is looking at years of adjustments to get back to the earnings trajectory investors were betting on. Humana executives including Chief Operating Officer Jim Rechtin, who is set to take the CEO seat later this year, projected optimism about the company’s long-term prospects.

JPMorgan Securities analyst Lisa Gill wrote that it’s difficult to see Humana returning to its long-term multiple, the level the stock trades relative to earnings. By the time Humana overcomes the rough spot ahead “we think investors could be focusing more on slowing demographic trends, as growth in the 65+ market is expected to moderate” in the second-half of the 2020s, she wrote.

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>>> Medpace Holdings, Inc. (MEDP) provides clinical research-based drug and medical device development services in North America, Europe, and Asia. It offers a suite of services supporting the clinical development process from Phase I to Phase IV in various therapeutic areas. The company also provides clinical development services to the pharmaceutical, biotechnology, and medical device industries; and development plan design, coordinated central laboratory, project management, regulatory affairs, clinical monitoring, data management and analysis, pharmacovigilance new drug application submissions, and post-marketing clinical support services. In addition, it offers bio-analytical laboratory services, clinical human pharmacology, imaging services, and electrocardiography reading support for clinical trials. Medpace Holdings, Inc. was founded in 1992 and is based in Cincinnati, Ohio.

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https://finance.yahoo.com/quote/MEDP/profile?p=MEDP



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AbbVie, Axsome - >>> 2 Biotech Stocks You Can Buy and Hold for the Next Decade


Motley Fool

January 2, 2024


https://finance.yahoo.com/news/2-biotech-stocks-buy-hold-134500692.html


There are many ways to grow one's wealth over a decade, but few are as accessible as investing in stocks. Even with a relatively modest sum, picking the right investments and letting time and compounding work their magic will generate the kinds of returns most people would be proud to achieve. However, with scores of options to choose from on equity markets, it can sometimes be challenging to know which stocks are worth investing in.

Let's consider two biotech stocks that could generate steady returns in the next 10 years: AbbVie (NYSE: ABBV) and Axsome Therapeutics (NASDAQ: AXSM).

1. AbbVie

AbbVie has been a terrific investment over the past decade. Revenue and earnings have generally grown at a good clip, and it has raised its dividend by 288%. Now that its blockbuster medicine Humira has seen its patent expire in the U.S., things are more complicated -- but that's no reason to give up on the company.

As Humira's sales drop, those of Skyrizi and Rinvoq, a pair of immunology medicines whose indications substantially overlap with those of Humira, are rising. Management expects this pair of drugs to exceed Humira's annual sales by 2027.

AbbVie is looking for growth elsewhere, too. It recently announced the acquisition of Cerevel Therapeutics, a neuroscience-focused biotech, for $8.7 billion in cash. The transaction will improve AbbVie's pipeline in that particular therapeutic area.

Back in 2020, AbbVie closed its acquisition of Allergan, which gave it access to key products, including its Botox franchise. There is nothing wrong with drugmakers relying on acquiring smaller companies to improve their lineups or pipelines, and that's what AbbVie is doing again.

The company does have an extensive pipeline of its own, with several dozen ongoing programs, many of which should result in brand-new approvals or label expansions. For instance, it launched a brand-new cancer medicine this year called Epkinly. So, despite its poor performance in the market this year, AbbVie isn't dead in the water -- far from it.

Patient investors can still expect the company to deliver solid returns and consistent dividend increases. AbbVie is part of the elite group of Dividend Kings: It has raised its payouts for 52 consecutive years, an impressive feat. The company's current yield is 4% -- much higher than the S&P 500's average of 1.62%.

With an underlying business that can still support dividend growth and a reasonable cash payout ratio of 42%, AbbVie can afford many more dividend hikes. That's another great reason to stick with this stock in the next decade.

2. Axsome Therapeutics

Axsome Therapeutics is a mid-cap biotech with just two products on the market. The company's recent financial results aren't great. In the third quarter, it posted revenue of just about $58 million, which soared by 243% year over year. Its net loss per share of $1.32 was worse than the net loss per share of $1.07 recorded in the prior-year period.

However, things could soon change for Axsome Therapeutics given its pipeline. The company has a string of potential approvals, regulatory submissions, and late-stage clinical trials due to start or release top-line data in the next 12 months. For instance, one of its products, depression treatment Auvelity, is seeking a label expansion in treating Alzheimer's disease agitation (aggressive and restless symptoms). The biotech is running a phase 3 clinical trial whose data should be revealed next year.

Auvelity is also being developed to help with smoking cessation, with a phase 2/3 study planned for next year. Axsome Therapeutics' other approved product, narcolepsy treatment Sunosi, is undergoing a phase 3 study targeting ADHD, with top-line results due in the second half of 2024. There is much more to the biotech's pipeline.

Axsome's lineup should look very different in the next three years. Considering that even its oldest approved product, Sunosi, has been on the market only since 2019, the company should be able to deliver solid top-line growth through the next decade.

That could translate into superior stock market returns, too -- especially since, with the company's market capitalization of just $3.5 billion, investors don't appear to fully appreciate the potential of Axsome's late-stage pipeline. That makes it an attractive biotech stock to buy now and hold.

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>>> Medpace Holdings, Inc. (MEDP) provides clinical research-based drug and medical device development services in North America, Europe, and Asia. It offers a suite of services supporting the clinical development process from Phase I to Phase IV in various therapeutic areas. The company also provides clinical development services to the pharmaceutical, biotechnology, and medical device industries; and development plan design, coordinated central laboratory, project management, regulatory affairs, clinical monitoring, data management and analysis, pharmacovigilance new drug application submissions, and post-marketing clinical support services. In addition, it offers bio-analytical laboratory services, clinical human pharmacology, imaging services, and electrocardiography reading support for clinical trials. Medpace Holdings, Inc. was founded in 1992 and is based in Cincinnati, Ohio. <<<



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>>> Medpace Holdings, Inc. (MEDP)

https://finance.yahoo.com/news/next-wave-biotech-3-stocks-170425474.html

Last on our list of biostocks to buy is Medpace Holdings, Inc. (NASDAQ:MEDP), a medical device services & drug research company that offers scientifically-driven clinical development services in the pharmaceutical, medical device, and biotechnology industries. It partners with several companies in the industry and provides them with product development services and execution of clinical trials. MEDP also offers full-service Phase I-IV clinical development services up to post-marketing clinical support. Its clinical trial services include bio-analytical laboratory services, imaging services, clinical human pharmacology, and electrocardiography reading support for clinical trials.

MEDP’s strong third quarter has showcased impressive results, with revenue growing 28.3% YoY. It also beat earnings estimates by 8.82% and is highly recommended by analysts. Even though the company experienced a slight dip in its net income margin to YoY (from 17.2% to 14.3%), its GAAP net income rose to $70.6 million and a strong EBITDA margin of 18.3%. Its consistent momentum and growth make it one of our top choices for biotech stocks right now.

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(!) >>> One in four who had Pfizer Covid jabs experienced unintended immune response


The Telegraph

by Joe Pinkstone

December 6, 2023


https://www.yahoo.com/news/more-one-four-had-mrna-171724613.html


More than a quarter of people injected with mRNA Covid jabs suffered an unintended immune response created by a glitch in the way the vaccine was read by the body, a study has found.

No adverse effects were created by the error, data show, but Cambridge scientists found such vaccines were not perfect and sometimes led to nonsense proteins being made instead of the desired Covid “spike”, which mimics infection and leads to antibody production.

mRNA jabs, such as the ones created by Moderna and Pfizer, use a string of genetic material to tell the body to create a specific protein that safely imitates an infection.

Research in the field, spanning decades, had been slow work. It often stalled because RNA itself is often attacked by the body as a foreign invader.

But in 2023, the Nobel Prize for Medicine went to the pair of scientists who had spent years working to fix the problem. It was done by taking one of the RNA bases, uridine, and swapping in a very similar synthetic alternative.

This breakthrough allowed scientists to create proteins in the body without the immune system attacking the jab.

It allows for quick and precise vaccines that are highly effective and was the backbone of the Covid vaccine response.

Not a perfect fit

It was thought the minor tweak to uridine caused no problems in cells, but a team of researchers at the University of Cambridge’s Medical Research Council (MRC) Toxicology Unit have now found when this partially synthetic code is read, the protein-making machine in the body sometimes struggles with the uridine analogues.

Because it is not a perfect fit for what is expected, there can be a momentary pause which causes the process to stutter and a letter in the code can get skipped, much like a bike slipping a gear.

This process, called frameshifting, throws out the way the code is interpreted as it relies on groups of three bases, known as codons, being read in the right order.

This issue, caused by the jab’s code, throws the process completely out of sync and the entire subsequent code becomes garbled.

In the case of the Covid jabs, the end result is a nonsensical and harmless protein, the team found, which the body attacks and leads to an immune system flare-up. The new study, published in Nature, found this occurred in around 25-30 per cent of people.

Rogue protein fear

The vaccine is read well enough to create the strong protection against the coronavirus, the scientists say, but the frameshifting issue creates what was, until now, an unknown off-target effect.

The code relating to the Covid vaccines was harmless and no issues were created. However the team say that subsequent mRNA vaccines used for other diseases or infections could, in theory, lead to viable proteins being created that are active in the body.

In this scenario not only is the vaccine not making the right protein, it could lead to a rogue protein being produced.

There is no evidence of this occurring in the Covid jabs, the authors stress, and they say any trials on other mRNA therapeutics would detect any such problems in early stages.

Dr James Thaventhiran, senior author of the report, said: “Research has shown beyond doubt that mRNA vaccination against COVID-19 is safe (lol). Billions of doses of the Moderna and Pfizer mRNA vaccines have been safely delivered, saving lives worldwide.”

The authors also found that there is an easy way to eradicate the frameshifting events which relies on changing the code of the mRNA drug to minimise the use of the problematic pseudo-uridine.

Replacing it with a natural base that when read as a trio still makes the correct amino acid is enough to stop the unwanted skips and therefore improve safety without sacrificing efficacy.

These findings were shared with medicines regulator MHRA around a year ago, the scientists say, and updated vaccines that use the improved form of mRNA are in the works for cancer jabs, and other therapeutics.

‘Revolutionary technology’

“This technology is amazing and it’s going to be revolutionary as a new medicine platform for all sorts of things, but we’ve just made it a whole lot safer going forward,” Professor Anne Willis, co-senior study author and director of the MRC Toxicology Unit told reporters.

“Ribosomes are somehow sensing the modified RNAs, but the Covid vaccines are very, very safe and very, very efficacious. (lol)

“But there are decoding issues with this technology that can cause stalling and frameshifting and we can get cellular immunity to these peptides after vaccination.”

However, she adds it is very exciting that there is a way to fix the issue, which “massively de-risks this platform going forward”. (great, now that most of the world has already been jabbed)

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>>> The Ensign Group Acquires Skilled Nursing Facility in Kansas

The Ensign Group, Inc.

October 6, 2023


https://finance.yahoo.com/news/ensign-group-acquires-skilled-nursing-100000326.html


SAN JUAN CAPISTRANO, Calif., Oct. 06, 2023 (GLOBE NEWSWIRE) -- The Ensign Group, Inc. (Nasdaq: ENSG), the parent company of the EnsignTM group of companies, which invest in and provide skilled nursing and senior living services, physical, occupational and speech therapies, other rehabilitative and healthcare services, and real estate, announced today that it acquired the operations of Providence Place, a 45-bed skilled nursing facility located in Kansas City, Kansas. Providence Place is located on the campus of Providence Medical Center. The acquisition was effective October 1, 2023 and will be subject to a long-term, triple net lease.

“This acquisition created a perfect opportunity for growth in Kansas, where we have been carefully reviewing opportunities for some time,” said Barry Port, Ensign's Chief Executive Officer. “We are thrilled to strengthen our relationship with Providence Medical Center and Prime Healthcare,” he added.

Spencer Burton, President of Gateway Healthcare LLC, Ensign’s Kansas-based subsidiary, added “This operation is well situated to become the operation-of-choice in its market. We are excited to work together with our healthcare partners as we strive to provide top-notch care for our patients and families we are honored to serve.”

This acquisition brings Ensign's growing portfolio to 296 healthcare operations, 26 of which also include senior living operations, across thirteen states. Ensign subsidiaries, including Standard Bearer, own 112 real estate assets. Mr. Port reaffirmed that Ensign is actively seeking opportunities to acquire real estate and to lease both well-performing and struggling skilled nursing, senior living and other healthcare related businesses throughout the United States.

About EnsignTM

The Ensign Group, Inc.'s independent operating subsidiaries provide a broad spectrum of skilled nursing and senior living services, physical, occupational and speech therapies and other rehabilitative and healthcare services at 296 healthcare facilities in Arizona, California, Colorado, Idaho, Iowa, Kansas, Nebraska, Nevada, South Carolina, Texas, Utah, Washington and Wisconsin.

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>>> Quipt Announces Multi-State Acquisition Adding Approximately $9 Million in Annualized Revenues, and Anticipated $2 Million in Adjusted EBITDA Post Integration


Businesswire

Quipt Home Medical Corp.

September 11, 2023


https://finance.yahoo.com/news/quipt-announces-multi-state-acquisition-113000568.html


Acquisition Expands Operations in Mississippi, Texas and Louisiana

CINCINNATI, Sept. 11, 2023 (GLOBE NEWSWIRE) -- Quipt Home Medical Corp. (“Quipt” or the “Company”) (NASDAQ:QIPT; TSX:QIPT), a U.S. based home medical equipment provider, focused on end-to-end respiratory care, is very pleased to announce that it has acquired a business with operations in Mississippi, Texas and Louisiana reporting unaudited annual revenues (12 months ending June 30, 2023) of approximately $9 million ?with anticipated Adjusted EBITDA (defined below) of $2 million post integration. As a reminder all financial figures stated are in USD.

Acquisition Details

The acquisition adds scale with ten locations across three states, 17,500 active patients, 1,900 unique referring physicians, important insurance contracts, and decades of operating experience in the markets served. This acquisition allows the Company to further penetrate key sales touch points in major target markets across Mississippi, Texas and Louisiana and is expected to assist with organic growth initiatives in those markets post-integration. Moreover, the business has a diverse payor mix and a heavily weighted respiratory product mix.

The operating footprint aligns closely with regions that have a high prevalence of Chronic Obstructive Pulmonary Disease (“COPD”), a key target patient group. According to National Institutes of Health (NIH) about 1.5 million people across the three states have COPD1. As a growing leader in clinical respiratory care, the favorable demographics, additional insurance contracts and infrastructure, afford Quipt the ideal conditions to accelerate its national expansion efforts.

The Company is pleased to share the following updated metrics on a consolidated basis taking into consideration the acquisition disclosed herein:

287,500 current active patients

34,400 referring physicians

125 locations across 26 U.S. States

Additionally, the acquisition adds significant opportunity to increase resupply revenue once sleep patients are onboarded to Quipt’s robust resupply program and the acquisition footprint is expected to create additional opportunities to expand Quipt’s access for accretive tuck-in acquisitions.

The acquisition increases Quipt’s current annual revenues by approximately $9 million and is expected to increase Quipt’s Adjusted EBITDA, post integration, by $2 million. The acquisition purchase price is at historical multiples paid by the Company.

Management Commentary

“The completion of this transaction demonstrates our ongoing patience and discipline as it relates to our capital allocation approach. At favorable terms, we were able to significantly expand in three attractive existing states. Given that there are more than 1.5 million COPD patients residing in Mississippi, Texas and Louisiana, we increase our footprint in those three states,” said Greg Crawford, Chairman and CEO of Quipt. “Our team of operators will once again utilize our tried-and-true integration approach to efficiently integrate this business onto our existing platform, continuing to build scale across the organization. Moreover, we believe there is an opportunity to leverage our resupply program immediately, creating actionable revenue synergies for us. Additionally, the substantial patient base and excellent referral network we have built up in these three states allow us to take a “land and expand” approach to future growth, which will support our organic growth goals.”

Chief Financial Officer, Hardik Mehta added, “This accretive transaction checks all the boxes for us, as we were able to acquire respiratory focused business in attractive markets at favorable terms. The acquisition adds $9 million in annual revenue and $2 million of Adjusted EBITDA post integration, which represents a very strong margin profile. We are very excited about the growth opportunities that will open as a result of this acquisition. Post-closing, we continue to possess a very strong balance sheet with significant flexibility to go after accretive acquisition targets that fit our stringent criteria. We anticipate a smooth integration process, which has served as the cornerstone of our consistently strong financial and operational results. As we look ahead, we will continue to expand our ability to serve critical geographic areas with our full range of respiratory care products and services.”

ABOUT QUIPT HOME MEDICAL CORP.

The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility, and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services, and making life easier for the patient.

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>>> Palantir secures contract with UK's National Health Service


Yahoo Finance

by Angel Smith and Seana Smith

October 4, 2023


https://finance.yahoo.com/video/palantir-secures-contract-uks-national-144918392.html


Palantir (PLTR) Co-Founder Peter Thiel has negotiated a service contract with the United Kingdom's National Health Service. The 5-year contract aims to strengthen the NHS's data analysis capabilities with Palantir providing access to its artificial intelligence tools. Yahoo Finance's Brad Smith and Seana Smith break down the details of this contract and the analysts chatter around it.

SEANA SMITH: The Palantir's co-founder Peter Thiel is set to secure a contract with the UK's National Health Service. Now, the controversial five-year contract is valued at more than 480 million, and it's meant to enhance the NHS's data analysis capabilities. Many, though, criticized the NHS's association with the analytics company, citing patient data privacy concerns, something that we know has been top of mind and an issue now for some time.

But when it comes to Palantir, whether or not that's going to materially move the business, we're seeing some excitement around this with shares up just about 2%. But, Brad, Palantir is a company and is a stock that initially at the start of the year was riding a lot of that enthusiasm for AI.

Palantir really saying that they are one of the critical players within AI. Over the last month or two, we've seen some on the street come out question just that and how quickly their business could potentially benefit from AI. Morgan Stanley was one of those on the sell side.

Analyst Keith Weiss coming out saying that stock's valuation fully reflects the AI euphoria, and any tailwind from this trend is going to take some time to materialize. So a deal like this may be offsetting some of those concerns. Year-to-date, we're still up nearly 140%, but we'll see what this deal does to its business.

BRAD SMITH: Yeah. Summer sputtered did not diminish some of those major returns that investors had seen. As you were mentioning, 140% roughly year to date returns for Palantir. And a company that hinges a lot on some of those major government contracts.

Of course, governments trying to figure out where they can deploy some of their own AI research and then additionally, kind of making sure that goes into their own defense mechanisms, so many different instances where Palantir already plays as well. So we'll see how they continue to be a near-term beneficiary, perhaps even further, long term as well.

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>>> Zoetis Inc. (NYSE:ZTS)

https://finance.yahoo.com/news/15-best-p-500-stocks-211112359.html

5-Year Average Dividend Growth: 24.5%

Number of Hedge Fund Holders: 65

Zoetis Inc. (NYSE:ZTS) is a global animal health company that specializes in the discovery, development, manufacturing, and marketing of a wide range of veterinary medicines and vaccines. The company currently pays a quarterly dividend of $0.375 per share and has a dividend yield of 0.81%, as recorded on September 11. In the past five years, it raised its dividends at an annual average rate of 24.5%, which makes it one of the best dividend stocks on our list.

The Procter & Gamble Company (NYSE:PG), Colgate-Palmolive Company (NYSE:CL), and PepsiCo, Inc. (NASDAQ:PEP) are some other dividend stocks to consider for growth.

Zoetis Inc. (NYSE:ZTS) was a popular buy among elite funds with 65 hedge fund positions at the end of Q2 2023, up from 55 in the previous quarter, as per Insider Monkey's database. The consolidated value of stakes owned by these hedge funds is over $1.1 billion.

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[Canna_Business]

Medical Cannabis -> $ITHUF
https://healthforlifedispensaries.com/maryland/

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>>> Mysterious 'brain disease' affecting the young leaves many questions unanswered


Indy 100

by Harriet Brewis

July 4, 2023


https://www.msn.com/en-us/health/medical/mysterious-brain-disease-affecting-the-young-leaves-many-questions-unanswered/ar-AA1doVX3?OCID=ansmsnnews11


A mysterious and, at times, fatal brain condition has been creeping its way insidiously across a Canadian province, claiming an unusually high number of young victims, according to local health experts.

Hallucinations, muscle spasms, memory problems and unexplained weight loss are among the symptoms reported by sufferers of the unidentified illness, which first came to the public’s attention in 2021 when 48 cases were recorded in New Brunswick.

Since then, the number has continued to grow, with some doctors and local residents suggesting it may exceed 200, with nine deaths already attributed to the enigmatic disease, the New York Post reports.

But it is the affliction of young people which is perhaps most baffling, given that this age group doesn’t normally present dementia-like symptoms or similar neurological problems.

“I am particularly concerned about the increase in numbers of young-onset and early-onset neurological syndrome,” neurologist Dr Alier Marrero wrote in a letter to New Brunswick’s chief medical officer and the chief federal public health officer earlier this year.

“Over the past year, I have been following 147 cases, between the ages of 17 and 80 years old. Out of those, 57 are early-onset cases and 41 are young-onset cases,” Marrero wrote, according to the Guardian, which obtained a copy of the letter.

And yet, despite all the unanswered questions surrounding the disease a government investigation into the causes of the condition was drawn to an abrupt close. (ie - a cover up)

Wrapping up its report in February 2022, the Public Health New Brunswick agency announced that there was no mystery illness, and an oversight committee concluded that people in the “cluster” of reported cases had probably just been misdiagnosed. (!)

It suggested they were simply suffering from known illnesses such as cancer or dementia (!)

However, Marrero is among the experts calling for further investigations, insisting that patients have been neglected by authorities in the Canadian province.

In his January letter to health chiefs, Marrero said that some of his patients were in “advanced stages of clinical deterioration and near end of life” as he pleaded for action.

Warning of “troubling” new developments, he said recent lab tests on a number of patients showed “clear signs of exposure” to the herbicide glyphosate, which is widely used by forestry companies in the region, according to The Guardian.

Marrero expressed concern that the presence of glyphosate and other compounds could be linked to toxins in the province, which are known for their harmful effects on the brain.

“Moreover, I underline again that many of our patients are young. This is concerning as it is quite rare for young patients to present with such symptomatology,” he pointed out in his letter.

A number of Marrero’s patients provided The Guardian with their test results, which showed detectable levels of glyphosate.

As the paper notes, it’s not clear whether the elevated levels of glyphosate do, indeed, have any link to the neurodegenerative symptoms suffered by the patients, and more testing would be needed to determine how high these levels are compared with the rest of the community.

However, in his letter, Marrero said he was worried that the presence of glyphosate could be connected to a number of blue-green algae blooms found in bodies of water throughout the region.

Glyphosate contains phosphorous that can stimulate blooms of blue-green algae, a type of cyanobacteria that can cause sickness in people and kill animals, the New York Post notes.

Patient advocates have joined Marrero in putting pressure on the local government to reopen its investigation into the mystery illness and its causes, with many speculating that pressure from industry or other groups might have fuelled the decision to close the case.

“For almost a year, we were led to believe that a thorough and unbiased public health investigation was in progress. We are here to tell you that that did not happen,” Stacie Cormier, one of the advocates, whose stepdaughter is suffering from neurological decline, told the Toronto Star.

“Provincial and federal health officials are misrepresenting our patient files and information. And they’re using this false information as a reason to abandon a public health inquiry.”

Cormier’s stepdaughter, Gabrielle Cormier, had to drop out of university and give up her passion for figure skating at 20 when she became ill with memory loss, vision problems, and an inability to stand for more than a few minutes.

She is now unable to walk unassisted.

Gabrielle Cormier went from being a passionate figure skater to requiring a cane or wheelchair to get around

She told local news outlet CTV News that she made her final visit to an ice rink back in 2021, because: “I was afraid that I was going to die and I wanted to be on the ice one last time.”

New Brunswick health authorities have so far declined to reopen their investigation into the illness or conduct any new environmental tests.

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>>> UnitedHealth Buys Amedisys for $3.3 Billion


Investopedia

by Vaidik Trivedi

June 26, 2023


https://www.msn.com/en-us/money/other/unitedhealth-buys-amedisys-for-3-3-billion/ar-AA1d4kiM


Health insurance behemoth UnitedHealth Group (UNH) agreed to buy home health and hospice caregiver Amedisys (AMED) for $3.3 billion in an all-cash deal that will expand UnitedHealth's home healthcare business.

KEY TAKEAWAYS

UnitedHealth Group has agreed to buy Amedisys, a home healthcare provider, for $101 per share.

Amedisys will pay a $106 million fee to terminate its merger with Option Care, which offered to buy
Amedisys for $97.38 per share in an all-stock agreement in May.

Amedisys will merge with UnitedHealth's subsidiary Optum after the deal gains shareholder and regulatory approval.

UnitedHealth will pay $101 per outstanding share of Amedisys in an all-cash transaction subject to shareholder and regulatory approval. Amedisys will merge with UnitedHealth subsidiary Optum.

The two companies had been negotiating the terms of the sale for weeks. UnitedHealth originally offered to buy Amedisys for $100 per share on June 5.

Amedisys had previously entered a merger deal with Option Care Health Inc. (OPCH), which offered in May to buy Amedisys for $97.38 per share in an all-stock transaction that valued the company at $3.6 billion. Amedysis will pay Option Care a $106 million termination fee to forfeit the agreement.

Amedisys is UnitedHealth's second home healthcare acquisition this year, as the company seeks to bolster its presence in the industry. It acquired LHC Group, a rival of Amedisys, for $5.4 billion in February.

Amedisys' stock was down 0.7% midday Monday, trading at around $90. UnitedHealth’s stock was up about 0.7%.

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>>> Align Tech (ALGN) -- We started with a stalwart of the online dating realm – but it’s always easier to find a date when you have a great smile, and the next stock, Align Tech, can help with that. Align works with both high tech and orthodontics; the company’s chief product is a clear orthodontic aligner used to straighten teeth. The company uses a line of high-end 3D scanners to manufacture its proprietary Invisalign product.


https://finance.yahoo.com/news/insiders-pour-millions-2-stocks-000640934.html


Align got its start back in the 1990s, and Invisalign was first approved for use in 1998. The company has grown to become a $23 billion giant in the last 25 years, and employs over 24,000 people globally. Align saw $3.8 billion in total revenue last year, and boasts some 15.1 million Invisalign patients since the product first hit the markets.

The current year started with both the top and bottom lines better than the analysts had expected. The 1Q23 revenue of $943.1 million beat expectations by $39.9 million, while the non-GAAP diluted EPS of $2.25 exceeded the consensus by 13 cents. However, the company’s case volume in 1Q23 of 575.4K slipped by 1% compared to 4Q22.

On a positive note, Align’s Clear Aligner revenue, its chief revenue driver, grew 8% quarter-over-quarter, despite the 1% slip in case volume. The company believes that increasing customer confidence, and the post-COVID easing of restrictions in China, will bring stability to the target market. Align is guiding toward 2Q23 revenue in the range of $980 million to $1 billion.

Notably, Kevin Dallas, a member of the firm’s Board of Directors, made a significant insider purchase last week. Dallas demonstrated his confidence in the company by investing nearly $2 million to acquire 7,000 shares of the stock. As a result, his total holdings of ALGN now amount to approximately $3.7 million.

Morgan Stanley’s 5-star analyst Erin Wright is also taking a bullish stance on Align. She writes of the company: “Our longer term thesis for ALGN remains, where its leadership positioning in an attractive, highly underpenetrated market, along with rising adoption of digital workflows should support +DD earnings growth LT. All in, with its shares now trading at 35.8x our 2024e EPS, at parity with its closest competitor Straumann, we do not believe its current valuation fully reflects its longer term growth prospects.”

Wright’s comments back up her Overweight (i.e. Buy) rating on the stock, and her price target of $383 implies a solid upside of 26% out to the one-year horizon. (To watch Wright’s track record, click here)

Once again, we’re looking at a stock with a Moderate Buy consensus rating from the Street. Align’s 7 recent analyst reviews break down to 5 Buys and 1 Hold and Sell each; the stock’s $349.33 average price target and $304.68 trading price suggests ~15% one-year upside potential.

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Healthcare REITS - >>> 'Commercial Real Estate Is Melting Down Fast': Elon Musk Warns Home Prices Will Be The Next To Crash — Yet One Property Type Could Prove Resilient


Benzinga

by Jing Pan

June 5, 2023

As a serial entrepreneur who co-founded Tesla Inc., revolutionized the electric car industry and is sending rockets into space, Elon Musk isn’t known for being a real estate guru. But lately, the billionaire has been sounding the alarm for the sector.

“Commercial real estate is melting down fast,” Musk said in a recent tweet. “Home values next.”

He elaborated on the dire forecast during an interview with former Fox News personality Tucker Carlson in April.

“We really haven’t seen the commercial real estate shoe drop. That’s more like an anvil, not a shoe,” Musk said. “So the stuff we’ve seen thus far actually hasn’t even — it’s only slightly real estate portfolio degradation. But that will become a very serious thing later this year, in my view.”

The Tesla CEO pointed out that the work-from-home trend has substantially reduced the use of office buildings around the world. And that does not bode well for commercial real estate.

“Almost all cities at this point have record vacancies of commercial real estate,” Musk said.

But not all commercial real estate is created equal. Here’s one type of property that could be more shockproof than others.

Medical Office Buildings

According to the latest Office National Report from commercial real estate brokerage Marcus & Millichap, medical offices face “fewer headwinds” because of the nature of their practice.

“While most medical office tenants have incorporated some degree of virtual work, hybrid interactions supplement in-person visits rather than replace,” the report said.

In other words, while the remote work trend has transformed the office property landscape, medical office buildings continue to serve a vital purpose because of the need for in-person visits.

Another compelling factor contributing to the resilience of medical offices is America’s aging population. Approximately 10,000 baby boomers reach age 65 in the U.S. every day, and the demand for medical services tends to increase as people grow older.

The report said that this demographic trend could be a backstop for long-term space demand.

To see how resilient medical office buildings are, look at Riverside-San Bernardino. The report highlighted that this region is expected to “maintain the lowest traditional office vacancy rate among major U.S. markets in 2023,” attributed in part to the presence of “strong medical office fundamentals.”

“Medical office vacancy here was at 6.8% in March,” the report said.

Getting A Piece Of The Action

Medical office buildings can be a significant investment, often requiring substantial capital to acquire. The good news? You don’t necessarily have to purchase an entire building. Nowadays, there are multiple avenues for investors to participate.

For instance, some publicly traded real estate investment trusts (REITs) own medical office properties. Investors can gain exposure to the segment by purchasing shares of these REITs.

Here’s a look at two that Wall Street finds particularly attractive.

Healthcare Realty Trust Inc. (NYSE: HR): Healthcare Realty Trust is a REIT that specializes in medical office buildings and outpatient facilities. The company’s portfolio consists of 715 properties in 35 states totaling approximately 41.8 million square feet.

Notably, 72% of the properties are on or adjacent to hospital campuses. The REIT pays quarterly dividends of 31 cents per share, translating to an annual yield of 6.7%. Barclays analyst Steve Valiquette has an Overweight rating on Healthcare Realty Trust and a price target of $25, implying a potential upside of 34%.

Ventas Inc. (NYSE: VTR): Ventas is a healthcare REIT with a broader focus. With more than 1,200 properties in the U.S., Canada and the U.K., the company’s portfolio spans senior living communities, medical offices and outpatient facilities and hospitals as well as life science, research and innovation properties. The stock offers an annual dividend yield of 4.1%. Mizuho analyst Vikram Malhotra has a Buy rating on Ventas and a price target of $53. Since shares trade at $43.70 today, the price target implies a potential upside of 21%.

Income investors are drawn to REITs because they are some of the higher-yielding names in the stock market. But remember, publicly traded REITs — including those that focus on medical properties — are still subject to the stock market’s ups and downs. If you don’t like the volatility associated with publicly traded REITs, note that there are also private market options that allow retail investors to add medical office buildings to their portfolios.

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>>> Wuhan lab leak ‘happened about the same time as Covid emerged’


The Telegragh

by Sarah Knapton

May 17, 2023


https://www.yahoo.com/news/wuhan-lab-leak-happened-same-183310737.html


The Wuhan Institute of Virology (WIV) suffered a viral laboratory leak or accident around the same time that Covid emerged in China, a new report has claimed.

On Wednesday, Florida senator Marco Rubio’s office released the findings of a 17-month investigation into the origins of coronavirus, which included previously undisclosed documents.

The new 329-page analysis reconstructs incidents that occurred in China in the years and months leading up to the pandemic.

Covid-19 first emerged in Wuhan in December 2019 close to where scientists at the WIV were collecting and studying bat viruses.

In a summary of the report, the team said documents suggested that “a serious biocontainment failure or accident, likely involving a viral pathogen, occurred at the state-run Wuhan Institute of Virology during the second half of 2019 - approximately during the same period of time in which the available epidemiological evidence indicates that Sars-CoV-2 was introduced to the human population in Wuhan”.

The team admitted there was no “smoking gun” within the documents, but said there was a “mountain of circumstantial evidence” that the Covid-19 pandemic likely came from a laboratory accident in Wuhan.

“After years of censorship, there is growing evidence that some type of lab accident is responsible for the Covid-19 pandemic,” said Mr Rubio.

The team said that from 2018, they had uncovered a series of inspection reports from WIV showing “hidden dangers”, “shortcomings” and various biosafety “problems” that were described as “critical” and “urgent”.

“A careful reading of reports from the WIV spanning more than a three-year period yielded a picture of a struggling institution: underfunded, under-regulated, and understaffed,” stated the report.

“The WIV was almost an accident waiting to happen, and it appears that an accident, or perhaps accidents, did happen, and roughly concurrent with the initial outbreak of Sars-CoV-2.”

Experts are still divided over how the virus first reached the human population, with many believing it is more likely to have jumped directly from bats or via an intermediary species.

Some scientists criticised the report’s conclusion, saying it showed no new data.

Commenting on the report, Peter Daszak, the president of EcoHealth Alliance, which worked with WIV, said it was focussed on a political chronology that “completely ignores the science”.

In the new report, the authors said they had found evidence that WIV staff were overworked and inadequately trained.

As early as January 2018, US diplomats reported safety concerns at WIV to Washington. By December 2019, a number of “rectification plans” were in place to deal with issues at the laboratory.

The following March, documents show that a number of repairs and renovations to laboratories had begun, but by July 2019 more work was required to renovate the hazardous waste system, disinfect the air and manage virus samples

By September 2019 - three months before China told the world about Covid - WIV advised Wuhan Airport to carry out a drill responding to a “novel coronavirus” and began stockpiling PCR tests, said the report.

The report also showed that around September-October 2019, there was a spike in hospital traffic in Wuhan while US diplomats in the city warned that an “unusually vicious flu season” was under way.

Athletes visiting Wuhan for the Military World Games also reported illness and in November 2019, several WIV researchers were hospitalised with Covid symptoms, according to US intelligence.

WIV staff were also asked to undergo training in biosecurity in November 2019, when they were visited by an important official from the Chinese Academy of Sciences.

During his visit, Ji Changzheng conveyed “important oral and written instructions” from Xi Jinping, the Chinese president, regarding the “complex and grave situation currently facing safety work”.

The report concluded: “Needless to say, we do not yet know with complete certainty that a biocontainment failure was responsible for the first human infection of Sars-CoV-2, but what we present is a substantial body of circumstantial evidence that supports the plausibility of such a scenario.”

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>>> Researchers discover a potential cause of Parkinson’s disease


University of Helsinki

https://www.helsinki.fi/en/news/brain/researchers-discover-potential-cause-parkinsons-disease


Researchers at the University of Helsinki have demonstrated that certain strains of Desulfovibrio bacteria are the likely cause of Parkinson’s disease in most cases. The study enables the screening of the carriers of Desulfovibrio strains and the removal of the bacteria from the gut.

Alfasynukleiini kertymä.

“Our findings are significant, as the cause of Parkinson’s disease has gone unknown despite attempts to identify it throughout the last two centuries. The findings indicate that specific strains of Desulfovibrio bacteria are likely to cause Parkinson’s disease. The disease is primarily caused by environmental factors, that is, environmental exposure to the Desulfovibrio bacterial strains that cause Parkinson’s disease. Only a small share, or roughly 10%, of Parkinson’s disease is caused by individual genes,” says Professor Per Saris from the University of Helsinki.

The goal of Professor Saris’s research group was to experimentally investigate whether the Desulfovibrio strains found in patients can result in progress towards Parkinson’s disease.

The principal finding of the group’s recently published study was that these strains in patients with Parkinson’s disease cause aggregation of the a-synuclein protein on a statistically significant level in a model organism for Parkinson’s disease. The worm Caenorhabditis elegans was used as the model organism.

The study also found that Desulfovibrio strains isolated from healthy individuals do not cause a-synuclein aggregation to the same degree. In contrast, the aggregates caused by the Desulfovibrio strains in patients with Parkinson’s diseases were also larger.

“Our findings make it possible to screen for the carriers of these harmful Desulfovibrio bacteria. Consequently, they can be targeted by measures to remove these strains from the gut, potentially alleviating and slowing the symptoms of patients with Parkinson’s disease. Once the Desulfovibrio bacteria are eliminated from the gut, a-synuclein aggregates are no longer formed in intestinal cells, from which they travel towards the brain via the vagus nerve like prion proteins,” Saris sums up.

Original article:

Vy A. Huynh, Timo M. Takala, Kari E. Murros, Bidhi Diwedi and Per E. J. Saris
Desulfovibrio bacteria enhance alpha-synuclein aggregation in a Caenorhabditis elegans model of Parkinson’s disease

Front. Cell. Infect. Microbiol., 01 May 2023Sec. Molecular Bacterial Pathogenesis
Volume 13 - 2023 | https://doi.org/10.3389/fcimb.2023.1181315

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>>> Parkinson's May Be Caused by a Common Aquatic Bacterium


ScienceAlert

by Mike McRae

5-8-23


https://www.msn.com/en-us/health/medical/parkinson-s-may-be-caused-by-a-common-aquatic-bacterium/ar-AA1aSIJZ?OCID=ansmsnnews11


Acommon genus of microbe found in wet, boggy environments could play a key role in the development of Parkinson's disease, by excreting compounds that trigger proteins inside brain cells to form toxic clumps.

The findings, made by a small team of researchers at the University of Helsinki and the University of Eastern Finland, build on the results of an earlier investigation showing that the severity of the neurodegenerative disorder in volunteers increased with concentrations of Desulfovibrio bacterial strains in their feces.

By now demonstrating a potential path from the presence of the bacteria in genetically edited worms to physical changes in the brain that coincide with Parkinson's disease, the researchers hope to one day improve early diagnosis of the disease in humans, or even slow its progress.

"Our findings make it possible to screen for the carriers of these harmful Desulfovibrio bacteria," says senior author Per Saris, a microbiologist at the University of Helsinki in Finland.

"Consequently, they can be targeted by measures to remove these strains from the gut, potentially alleviating and slowing the symptoms of patients with Parkinson's disease."

Ever since the English physician James Parkinson first described the disease as a neurological condition some two centuries ago, researchers have sought an explanation for why some people develop a drastic loss of fine motor control as they age.

Physiologically speaking, small inclusions known as Lewy bodies accumulate in the cells of specific regions of the brain of individuals diagnosed with Parkinson's disease.

More recently, investigations of these microscopic clumps of material have revealed them to largely consist of a type of protein called a-synuclein, which is typically involved in the release of neurotransmitters.

Just how this clumping contributes to the pathology of Parkinson's still isn't entirely clear, though it's suspected the very presence of these concentrations, called protofibrils, can't be great for the healthy functioning of nerve cells.

New test could lead to early Parkinson's detection

What is also something of a mystery is the initial cause of a-synuclein's aggregation. Though Parkinson's can run in families, genetics only seems to explain around 10 to 15 percent of all cases.

That leaves environmental conditions as a probable suspect, with studies finding the kinds of bacteria we harbor in our guts predicting the likelihood of an individual having, or at least developing, Parkinson's symptoms.

With Saris's 2021 study, there was finally evidence of a single prime suspect researchers could focus on.

"The disease is primarily caused by environmental factors, that is, environmental exposure to the Desulfovibrio bacterial strains that cause Parkinson's disease," says Saris.

In the new study, Saris and his team took fecal samples from 10 patients with Parkinson's disease and their healthy spouses, and isolated any strains of Desulfovibrio present.

Along with two different control groups of bacteria belonging to a completely different genus, the extracted test microbes were then fed to transgenic specimens of Caenorhabditis elegans nematode, which had been modified to express human a-synuclein.

A statistical analysis based on microscopic observations of the nematodes' heads revealed those fed Desulfovibrio were indeed far more likely to produce a-synuclein clumps, and those clumps were more likely to be much larger.

Tellingly, Desulfovibrio strains collected from Parkinson's patients were also better at aggregating the proteins in C. elegans than those collected from their partners.

What's more, those worms typically died in larger numbers than those in control groups.

Of course, there's a world of difference between worms and humans. While the same experiment could never be replicated in a sample of healthy people, studies will continue to look closely at ways Desulfovibrio in our own guts might spark the formation of a-synuclein aggregates that could migrate through the body.

In time, we may even be able to manage the progress of Parkinson's disease using therapies that target the digestive system and its surrounding nerves, instead of the brain. (Hippocrates --> 'All disease begins in the gut')

"Once the Desulfovibrio bacteria are eliminated from the gut, a-synuclein aggregates are no longer formed in intestinal cells, from which they travel towards the brain via the vagus nerve like prion proteins," Saris suggests.

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>>> Gut bacteria may hold the key to preventing Parkinson's disease, say Finnish scientists


Euronews

by Camille Bello

5-9-23


https://www.msn.com/en-za/news/other/gut-bacteria-may-hold-the-key-to-preventing-parkinson-s-disease-say-finnish-scientists/ar-AA1aXbci


Finish scientists say they have found that certain strains of gut bacteria are also the probable cause of Parkinson's disease.

Alzheimer’s, depression and obesity are all diseases that could potentially be prevented, if not treated, by the right balance of bacteria, fungi and virus that live naturally in our guts – known as the “gut microbiome”.

Now, Finish scientists say they have found that certain strains of gut bacteria are also the probable cause of Parkinson's disease.

A common age-related neurodegenerative disorder, Parkinson’s causes unintended or uncontrollable movements and affects some eight million people worldwide. But despite more than 200 years of research, its underlying causes are not fully understood.

Thanks to microbiome research, however, the enigma has finally been enlightened.

“Parkinson’s is primarily caused by environmental factors, that is, environmental exposure to the Desulfovibrio bacterial strains, and only a small share, roughly 10 per cent, is caused by individual genes,” said Professor Per Saris, lead researcher, from the University of Helsinki, in a statement.

Previous research by Saris’ team had already determined that the Desulfovibrio (DSV) bacteria - a type of bacteria that absorbs toxic sulfate - was more prevalent and abundant in quantity in Parkison’s disease patients, especially those experiencing more severe symptoms, when compared with healthy individuals.

However, it had not been investigated how the bacteria played a role in the disease’s development.

But the team’s most recent experiments published in the scientific journal Frontier - which compared faecal samples from 10 Parkinson’s patients and their healthy spouses - have confirmed the hypothesis.

Saris’ team found that DSV bacteria enhance the aggregation of a neuronal protein called alpha-synuclein - a protein that is found primarily in neurons in the brain - which is a hallmark of the disease.

Last year, a 72-year-old Scottish woman named Joy Milne accidentally provided a significant breakthrough in the detection of Parkinson’s.

She had noticed that her husband's smell changed 12 years before his diagnosis with Parkinson's, noting he had developed a musky scent, different from his usual scent.

A team at the University of Manchester then harnessed her power and discovered that Parkinson’s disease does indeed have a particular odour.

And with Milne’s help, they developed a test that could determine in just three minutes whether someone has the disease.

Saris says Milne’s discovery is aligned with his own team’s discoveries.

“There were a few studies about what compounds were causing the smell and I checked if the Desulfovibrio bacteria had the capacity to produce these compounds, and guess what was the result? Yes, they can, no surprise,” he told Euronews Next.

Woman who can ‘smell’ Parkinson’s disease helps scientists develop 3-minute skin swab test

For years, patients and doctors have signalled intestinal problems as a possible indicator of Parkison’s disease.

“People have reported experiencing constipation months before the symptoms first come in, and for a long time, this has had people thinking there might be a toxin or bacteria that was initiating the development towards Parkinson's disease,” Saris said.

His team’s findings appear to confirm that theory, while also providing an opportunity “to identify those with high numbers of bacteria in their intestine, and then determine who would be at risk of developing Parkison’s in ten or 20 years”.

Saris also hopes doctors could conduct screenings to detect the Parkinson-associated bacteria - and subsequently remove it from the gut, “potentially alleviating and slowing the symptoms of patients with Parkinson’s disease”.

“We already developed a method to kind of easily detect if you have a lot of Desulfovibrio in your faeces,” he notes.

The first poo transplant treatment has been approved in the US. How does faecal therapy work?

Where does the Desulfovibrio come from?

“Many people have this strain in their intestines,” said Saris.

“It is in the environment, in the soil, in the water, and also in foods. We basically eat them every day, but in a normal situation, they don't grow to very high numbers. Also, in a normal situation, you have this nitrogen sulfide detoxification enzyme that will keep you healthy”.

Saris says they are still running tests to determine which are the best foods to inhibit the development of the Desulfovibrio strains. However, he recommends “a more vegetarian-based diet, with a good amount of fibre”. (avoid lectins)

“It's known that there is a correlation between meat consumption and Parkinson's disease,” he noted.

The Finnish scientist also recommends avoiding any behaviour that causes a risk of inflammation in the intestines, (avoid lectins) “and that means, if possible, no stress,” he says.

“Be loved and love somebody, go into nature, be in contact with microbes in the forest and in contact with animals,” he advises, assuring that in conjunction with a good diet, it “will help the intestine avoid a state of inflammation”. (avoid lectins)

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>>> Quipt Home Medical Receives Conditional Approval to Graduate to the Toronto Stock Exchange


Quipt Home Medical Corp.

May 2, 2023


https://finance.yahoo.com/news/quipt-home-medical-receives-conditional-113000444.html


CINCINNATI, May 02, 2023 (GLOBE NEWSWIRE) -- Quipt Home Medical Corp. (“Quipt” or the “Company”) (NASDAQ:QIPT; TSXV:QIPT), a U.S. based home medical equipment provider, focused on end-to-end respiratory care, is very pleased to announce that it has received conditional approval from the Toronto Stock Exchange ("TSX") to graduate its listing from the TSX Venture Exchange (the "TSXV") to the TSX.

“Graduating to the Toronto Stock Exchange is a significant accomplishment, and I want to thank all our team members and shareholders for their ongoing support. Our ability to up-list demonstrates the evolution of our organization through the years and the ongoing momentum across the business in real time as we strive to become a national leader in respiratory care throughout the United States,” said Greg Crawford, Chairman and CEO of Quipt. “This up-listing is an important step towards improving liquidity and increasing our investor audience in North America and abroad. Given the continued financial and operational success, this up-listing, and our effort to inform investors of our robust growth, have us extremely optimistic about the future.”

Final approval of the listing is subject to the Company meeting certain customary conditions required by the TSX. The Company is working diligently to satisfy such listing conditions. Further details and a timeline for graduation will be announced in due course. Upon satisfaction of the TSX listing conditions, Quipt’s common shares will be delisted from the TSXV.

Shareholders are not required to exchange their share certificates or take any other action in connection with the TSX listing, as there will be no change in the trading symbol or CUSIP for the common shares. The Company will continue to trade its common shares on the NASDAQ in the United States under the symbol "QIPT".

ABOUT QUIPT HOME MEDICAL CORP.

The Company provides in-home monitoring and disease management services including end-to-end respiratory solutions for patients in the United States healthcare market. It seeks to continue to expand its offerings to include the management of several chronic disease states focusing on patients with heart or pulmonary disease, sleep disorders, reduced mobility, and other chronic health conditions. The primary business objective of the Company is to create shareholder value by offering a broader range of services to patients in need of in-home monitoring and chronic disease management. The Company’s organic growth strategy is to increase annual revenue per patient by offering multiple services to the same patient, consolidating the patient’s services, and making life easier for the patient.

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