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Pay attention, looks like we have a change in the last immune escape variants. They may have also become more heat tolerant, or more stupid monkeys are hanging out with eachother. Uptick in Delta.
Don't forget to order your Ivermectin while everyone is distracted by idiot Joe.
Vaxneuvance is already FDA-approved for adults (#msg-164961310), but I don’t think Vaxneuvance will compete effectively with PFE’s Prevnar-20, which has broader coverage of pneumococcal serotypes and a simpler (one-shot) treatment course (#msg-166441188).
p.s. MRK pays PFE a royalty of 7.25% on worldwide Vaxneuvance sales during 2022-2026 and a 2.5% royalty during 2027-2035 (#msg-166075692).
Thanks DewDiligence. The reason I ask, is that after no trial updates since January 2013, on October 27, 2021, ANIP or an undisclosed partner filed a Clinical Trial Certification/Extension request for their 3,656 patient long-term safety/efficacy Libigel trial. A request to delay submitting results for up to 2 years or 30 days after approval. Though it does not specify if it was a Certification or Extension request, a Certification is usually submitted in relation to filing an NDA.
In looking at the study design, the trial was completed on December 2012 (pre-commercialization part of the study). However even the if full trial was completed in August 2016, as listed in the clinical trial history (full safety/efficacy study including post approval observations), there is no obligation to submit results, let alone make request for a delay in submitting results, unless they have or were about to file an NDA.
Then Ms. Elizabeth Powell joined the Rare Disease Business Unit at ANI as Chief Compliance Officer and Head of Legal, Rare Disease in February 2022, assuming responsibility for the Legal and Compliance functions. For the past 24 years, Ms. Powell worked at Merck & Co., Inc., where she was responsible for strategic counsel related to commercial, compliance and FDA regulatory issues, and most recently served as Managing Counsel and Executive Director, U.S. Commercial & Compliance Legal.
Ironically, ANIP advanced their Annual Stockholder meeting from June 2, 2021 to April 27, 2022, which is exactly 6 months after they submitted their Certification/Extension request. It makes me wonder if ANIP or more likely a partner filed an NDA and got a 6-month Priority Review for Libigel.
To date ANIP has never publicly released that Libigel reduced Cardiovascular events in post menopausal women at risk of cardiovascular events by at least 70% (discovered in 2011 or earlier) and they never announced the that it reduced Breast Cancer events by an undisclosed amount (discovered in December 2015 or sooner). Both discoveries are only publicly available in patent applications and related prosecutions.
I realize Merck is facing an LOE for Januvia and Janumet in 2022 (China and EU) and January 2023 (US) and wondered if they are looking to Libigel to offset some of the losses. It would be the first FDA approved female testosterone drug with an instant market in replacing existing off label and compounded testosterone, currently being prescribed.
It appears to fit Merck's criteria for acquisition and partnership - Fills an unmet need. - Looking at their R&D and Products page, it appears to fit into at least two of their Areas of Focus, Cardio-metabolic disorders and Oncology.
The following are some indications that the Position Statement identified as needing more information before making recommendations: - Cognitive performance, or to delay cognitive decline, in postmenopausal women. - Impact of testosterone treatment on musculoskeletal tissues - Prevention of breast cancer (Libigel trial appears to answer this) - Cardiovascular safety in women at risk (Libigel trial appears to answer this and indicates prevention capbilities). It creates an R&D roadmap, with the potential of female testosterone eventually becoming a franchise drug with multiple indications.
FYI the patient population from the of the Libigel safety/efficacy trial included postmenopausal women suffering from the following. - Hypertension - Dyslipidemia - Diabetes mellitus It also included smokers.
It may all be coincidences, but evidence supporting an NDA filing, Ms. Powell coming over ANIP after 24 years with Merck, the Areas of Focus for Merck that Libigel addresses and the Pipeline Page's Key Therapeutic Ares having an empty Women's Health box, left me wondering if as you stated was a clerical error. Or, if Merck and ANIP have entered into a yet to be disclosed partnership.
Curiously, in the pre-specified subgroup with PD-L1>=50%, Keytruda’s DFS compared to placebo had a non-statsig HR=0.82—a worse result than in the overall trial.
The HR for OS, a secondary endpoint that is not yet mature, was 0.87.
All told, this is not a great dataset, IMO, but it may be enough for FDA approval. These data may put Keytruda at a competitive disadvantage to Tecentriq and Opdivo in early-stage NSCLC.
Upon looking at Merck's Pipeline webpage I see that Women's Health is included in their Therapeutic Key Areas, yet when you look at Phase two, Phase 3 and Under Review Sections there are no products in this category.
BIG PHARMA INCLUDING MERCK IN TROUBLE WITH NEW PATENT FREE ***TRADITIONAL*** COVID VACCINE!!!!!
New Patent-Free COVID-19 Vaccine Developed in Texas
A new patent-free COVID-19 vaccine is being offered to vaccine manufacturers across the world thanks to researchers from the Texas Children’s Hospital and Baylor College of Medicine.
The vaccine, called Corbevax, is based on traditional protein-based technology that has been used safely for decades, according to New Atlas. Similar to the other available COVID-19 vaccines, this one focuses on coronavirus spike protein, but instead of using mRNA to direct our cells to produce those spike proteins, it delivers lab-grown spike proteins to the body.
Researchers took the gene that codes for the spike protein and engineered yeast to produce it. The proteins are collected, purified and combined with an adjuvant to enhance immune responses.
“Protein-based vaccines have been widely used to prevent many other diseases, have proven safety records, and use economies of scale to achieve low-cost scalability across the world,” Maria Elena Bottazzi, one of the project’s lead researchers, said.
In late 2020, the team developing the vaccine teamed up with India-based Biological E to begin clinical trials and establish manufacturing capacity. Those trials, in 2021, included thousands of participants and found the vaccine to be safe and effective.
Antibody responses to Corbevax indicate the vaccine should be at least 80 percent effective at preventing symptomatic COVID-19 from the delta variant. Data corresponding to the omicron variant is expected soon.
The vaccine has been developed as a patent-free product that can easily be manufactured around the world. One of the researchers leading the project, Peter Hotez, described it as a “gift to the world.”
“This announcement is an important first step in vaccinating the world and halting the pandemic,” Hotez said. “Our vaccine technology offers a path to address an unfolding humanitarian crisis, namely the vulnerability the low – and middle-income countries face against the delta variant.”
India Won't Add Merck's COVID-19 Pill To National Treatment Protocol, Citing Safety Concerns
India’s top health research body announced on Wednesday that it won’t be adding Merck’s COVID-19 antiviral pill molnupiravir to its national treatment protocol, citing concerns over its safety.
The state-run Indian Council of Medical Research (ICMR) said it had become aware of “major safety concerns” that prompted the decision, despite India’s drug regulator in December approving the drug for emergency use.
It comes after France in December also canceled its order for the drug, developed by Merck and Ridgeback Biotherapeutics, following disappointing trial data suggesting its drug was markedly less effective than previously thought.
“Molnupiravir has major safety concerns including teratogenicity, mutagenicity, muscle and bone damage. If this drug is given, contraception must be done for three months as the child may have problems,” ICMR Director-General Balram Bhargava told local media on Wednesday.
Bhargava noted that the United States Food and Drug Administration (FDA) issued an emergency use authorization for Merck’s COVID-19 pill based on 1,433 patients with a 3 percent reduction in moderate disease when given in mild cases.
Members of the FDA’s Antimicrobial Drugs Advisory Committee in November voted 13 for and 10 against the emergency use authorization for molnupiravir, agreeing with the idea that the drug’s benefits outweigh its potential risks, including concerns about potential birth defects.
However, “we must remember that this drug has major safety concerns,” Bhargava said, adding that the drug causes teratogenicity, or the ability to cause defects in a developing fetus, mutagenicity, or permanent transmissible changes in the structure of genetic material of cells, cartilage damage, and can also be damaging to muscles.
Moreover, Bhargava said contraception would also have to be given to individuals who take the drug—regardless of whether they are male or female— because “the child born could be problematic with teratogenic influences.”
“The WHO has not included it, the UK has not included it as of now. As of now, the current recommendation stands that it is not part of the national taskforce treatment,” Bhargava said.
However, Bhargava said that experts will continue to discuss the potential use of the treatment in the country, where virus case numbers are currently surging.
Molnupiravir is intended for use at home by adults with mild to moderate COVID-19 who are at high risk of developing severe disease. The drug is taken orally in pill form, twice a day for five days, within five days of symptoms onset.
Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy. Company studies in rats showed that the drug caused birth defects when given at very high doses. FDA staffers concluded the data “suggest that molnupiravir may cause fetal harm when administered to pregnant individuals.”
Merck says that there is “no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.”
Around 13 Indian companies, including Cipla, Sun Pharma, and BDR, are manufacturing molnupiravir.
Indian multinational pharmaceutical company Dr. Reddy’s Laboratories was set to roll out a generic version of the oral antiviral medication starting from next week at an extremely affordable treatment rate of 1,400 rupees ($18.84), 37 times cheaper than in the United States.
The Epoch Times has contacted Dr. Reddy’s Laboratories and Merck for comment.
MERCK IS LATE TO THE PARTY, WITHOUT 94% FALSE POSITIVE PCR TESTING THERE IS NO PANDEMIC, SO NOW THERE IS NO REASON FOR COVID-19 VACCINES OR PILLS. THE WHOLE SCAMDEMIC IS UNRAVELLING!!!!
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.
Emphasis added.
The limitation is warranted, IMO, in light of Molnupiravir’s weak efficacy and questionable safety.
- An advisory panel to the U.S. Food and Drug Administration voted to grant emergency authorization to Merck’s oral COVID-19 pill molnupiravir (Lagevrio) — by a narrow 13-to-10 margin - Among those who received the drug, the rate of all-cause hospitalization or death was 6.8%, compared to 9.7% in the placebo group — a relative risk reduction of just 30% - The full data showed more hospital admissions among patients taking molnupiravir (6.2%) than among those taking a placebo (4.7%) - Molnupiravir works by triggering mutations that ultimately kill the virus; a risk of cancer and birth defects is possible, and the drug shouldn’t be taken by pregnant or breastfeeding women or children - By driving mutations but not killing off all of the virus — such as if people don’t take the full course of the drug — new and deadlier variants could be unleashed across the globe - The U.S. government is already on the hook for about 3.1 million courses of molnupiravir, which it bought for approximately $2.2 billion
A study published this week by researchers at the University of Hong Kong’s Faculty of Medicine said that the omicron variant replicates 70 times faster in human airways than delta, but infection in the lungs appears to be less severe compared with the original virus strain.
I call BS! 70X is mass cell destruction! Should be worse a whole lot quicker! Well at least in the countries that don't use Ivermectin.
NY Times Casually Admits New FDA-Approved Merck COVID Drug Might Actually Mutate Healthy Human DNA by Accident and Impact Male Fertility.
In normal times, in a normal world, this news might make headlines. But in 2020 during the Big Pharma bonanza pandemic, it’s stuffed at the bottom of the New York Times article.
The new Merck drug molnupiravir was approved two weeks ago by the Food and Drug Administration. The “expert” committee narrowly voted to recommend authorizing the drug.
But hidden towards the bottom of the article you learn molnupiravir might actually mutate healthy DNC by accident.
How serious a problem is that?
A team of researchers at the University of North Carolina studied the use of molnupiravir in isolated hamster cells over 32 days and found that the drug did induce mutations in DNA.
Those mutations could “contribute to the development of cancer, or cause birth defects either in a developing fetus or through incorporation into sperm precursor cells,” the authors of that study wrote.
The drug targets only dividing cells, which are relatively sparse in an adult. That poses a narrower risk than other mutagens, like radiation, which can damage DNA in all types of cells.
Still, Ronald Swanstrom, an HIV researcher at the University of North Carolina at Chapel Hill who helped lead the hamster cell study, said that adults had enough dividing cells — in bones, for example, and in the lining of the gut — to cause concern. He also noted that men were constantly making dividing sperm cells that could carry potential mutations.
Oh, and it could affect men wanting to become fathers.
The FDA advisers also noted that the risks could extend to other patients, including men wanting to become fathers, though those risks remain poorly understood and Merck said its own studies had turned up no evidence that the drug causes DNA mutations.
The trial that led to MRK’s dropping MK-8507 was testing the combination of MK-8507 and Islatravir. Although MRK says Islatravir did not play a role in the observed safety problem, it sounds like GILD is not fully convinced.
It’s baffling that Molnupiravir efficacy dropped precipitously from the interim analysis to the final analysis; during the post-interim portion of the trial, patients in the Molnupiravir arm actually did worse than those in the placebo arm.
Moreover, in a trial such as this one with a very short treatment period (5 days), it’s unlikely that crossover from the placebo arm to the Molnupiravir arm after unblinding could have had a material impact on efficacy.
The FDA advisory panel for MRK’s EUA request is next Tuesday. Perhaps we’ll have a better understanding of what happened after the meeting.
MRK’s presenter at the FDA adcomm just said that he has no valid explanation for the observed fall-off in Molnupiravir’s efficacy relative to placebo in the portion of the trial following the interim analysis other than that the placebo arm overperformed (LOL).
Merck's COVID-19 pill significantly less effective in new analysis
Nov 26 (Reuters) - Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck's drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc's trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.
Merck's shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency's staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.
EASIER TREATMENT
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck's is designed to introduce errors into the genetic code of the virus. Pfizer's drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.
Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.
The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also had to use birth control.
Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
Merck’s new COVID drug, Molnupiravir, is dangerous and unproven
OP-ED DANIEL HOROWITZNovember 22, 2021
First it was lockdowns, then masks, then a series of failed shots and boosters, with a side-dish of remdesivir killing people in hospitals while blocking lifesaving treatments. Now, the same forces within big pharma are about to unleash their first outpatient drug on us. Are we really to believe that this will suddenly be the first pristine COVID product from big pharma that actually helps rather than harms us? Color me skeptical, especially based on what we know about Merck's supposed wonder drug, Molnupiravir.
First, it's important to note that the medical establishment has made it clear they will not touch a repurposed drug so long as it's off-patent. However, they have no problem using repurposed drugs that are expensive and unsafe as they did with remdesivir (which was repurposed from the Ebola virus) after it killed so many people and had to be pulled from trial. Well, Molnupiravir is also a repurposed drug. Wait for it … Molnupiravir is actually repurposed from a horse drug!
Merck's Molnupiravir, also known as (EIDD-2801), was originally co-developed by Ridgeback Biotherapeutics LP and a biotech company owned by Emory University in 2003 to treat equine encephalitis and was later purchased by Merck to be used for coronavirus. There is nothing novel about the drug. It is a nucleotide analogue that introduces errors in the viral RNA at the time of replication after to cause mutations. The problem with mutagenic drugs is that they are known both to cause side effects, such as cancer and birth defects, in the individual, as well as spawn mutations in the virus — not coincidently similar to the leaky vaccines currently being used.
The reason drugs like ivermectin that work "accidentally" against viruses are so much safer is precisely because they don't attempt to go after the virus in an offensive way, running the risk of damaging good cells and causing mutations. It's actually a good thing that they are not traditional anti-virals and work in a defensive way. The reason we have so few anti-virals in the first place is because they are dangerous to the patient, sort of like chemotherapy.
Merck is asking for federal emergency use authorization at the same time the federal government has signed a $1.2 billion contract with them based on a single safety study conducted by ... you guessed it ... the very entity itself. Interestingly enough, the study participants were bizarrely told to abstain from "heterosexual intercourse" during the trial, a rare and interesting distinction for a trial protocol in an anti-viral therapeutic. But, in fact, they understood that this technology, which works similar to chemotherapy, is not safe for women of childbearing age who want to have children in the future. As Dr. Simon Clarke, associate professor in cellular microbiology at the University of Reading, said, the specific instructions on heterosexual sex "suggests that the drug has the potential to cause birth defects should someone become pregnant."
Much like vaccines, anti-viral agents have to be formulated perfectly. If they fail to fully kill the virus, they run the risk of having the virus mutate and becoming more virulent, akin to shooting at the king and missing.
Also, in the same way anti-virals attack the genetic makeup of the viruses, they have the potential to damage the hosts as well, just like we see with anti-cancer drugs. "Proceed with caution and at your own peril," wrote Raymond Schinazi, a professor of pediatrics and the director of the division of biochemical pharmacology at the Emory University School of Medicine, who has studied NHC for decades, in an email to "Barron's" last month.
After the body ingests Molnupiravir, it produces a compound called NHC (N-hydroxycytidine). Schinazi, who works at the university that originally developed the drug, co-authored a paper in the Journal of Infectious Diseases a few months ago warning that NHC caused mutations in animal cell cultures. Schinazi used to own a biotech company that once attempted to pursue this drug, but abandoned it in 2003 once it was discovered it's mutagenic tendencies.
Barron's also interviewed Dr. Shuntai Zhou, another author of the study and a scientist at the Swanstrom Lab at UNC, who claims he warned Merck last year about their initial findings.
"There is a concern that this will cause long-term mutation effects, even cancer," Zhou says.
Zhou says that he is certain that the drug will integrate itself into the DNA of mammalian hosts. "Biochemistry won't lie," he says. "This drug will be incorporated in the DNA."
What impact it will have when it's there is unknown, given the various systems human cells use to limit the impact of mutations. Well, that sounds like a drug we want to dive into headfirst while we have safe, cheap, and effective alternatives.
Merck disputes these claims and suggest their studies show otherwise. But are we really to once again place our blind trust in a company that stands to make billions when known molecular biological principles should caution us against proceeding forward with this technology? Why would we spend billions on an untested drug with a dangerous mechanism of action when safe, off-patent, repurposed drugs already work better without the risk?
In another violation of informed consent, Merck was given $356 million in taxpayer funding at the beginning of the pandemic to develop this already-developed drug, despite opposition at the time from former director of the Biomedical Advanced Research and Development Authority (BARDA) Rick Bright. He warned that "similar experimental drugs in this class had been shown to cause reproductive toxicity in animals, and offspring from treated animals had been born without teeth and without parts of their skulls."
It is simply indefensible to pursue a drug like this when we already have established, effective, less expensive drugs that are actually safe. Even on side of efficacy, it's becoming harder to take Merck's press released "study" at face value. Two Indian companies that contracted with Merck have already pulled out of the deal because they believe it has no efficacy against moderate COVID-19 infections. Merck had already suspended its trials on Molnupiravir for hospitalized COVID patients, but in October, Aurobindo Pharma Ltd and MSN Laboratories pulled their studies after the drug failed to yield positive results with those who already had a moderate version of the virus.
The fact that Merck is seeking approval to make this drug a standard of care after their trial only followed up on safety data for 29 days in the human trials is unprecedented. The results of their human "trial" were never published in a peer-reviewed journal, the same as a press release released only on their website. "Merck says" their drug is safe and effective is in line not just for approval in the free market, but for government purchases of over a billion dollars' worth of doses.
In the preprinted results of the study by Ridgeback employees last December, they made mention of toxicity in the bone marrow found in the dogs that were part of the animal trial. Interestingly enough, when the study was published in an actual journal several months later, the reference to toxicity in the bone marrow disappeared. However, in the approval paper from the U.K.'s Medicines and Healthcare Products Regulator Agency, they mention, "Reversible, dose-related bone marrow toxicity affecting all haematopoietic cell lines was observed in dogs at ≥17 mg/kg/day (0.4 times the human NHC exposure at the recommended human dose (RHD))." That is not a large enough dose to achieve toxicity.
Shockingly, the U.K. regulator also concedes that "Carcinogenicity studies with molnupiravir have not been conducted," even though long term cancer risks are always a concern with nucleotide analogues. The agency also revealed that "No clinical interaction studies have been performed with molnupiravir."
Sadly, from everything we have seen with the shots and with remdesivir, the less safety data that is available, the more likely the FDA is to approve the drug — in violation of 100 years of standard protocols for drug approval.
FDA to meet with MRK for its COVID antiviral pill, on 11-30-21 --
The committee will discuss Emergency Use Authorization (EUA) 000108, submitted by Merck & Co. Inc., for emergency use of molnupiravir oral capsules for treatment of mild to moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
AS I SAID BEFORE "Cancer causing Molnupiravir is a FLOP, Merck should pull this toxic poison from the market immediately before too much damage is done. Massive class action lawsuits are coming Merck's way if they don't."
SHAME ON MERCK FOR PUSHING THIS DANGEROUS DRUG ON THE UNSUSPECTING PUBLIC!!!!
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