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‘ paper has been submitted and will be published before long ‘
‘ … published before long ‘
Bloomberg professional $2k per month plus live data costs , 2 years minimum ..
`...Submitted and will be published before long `
Didn’t LG and DI say numerous times to their regular callers friends the application in itself is material and would be PR’d though ?
The Chief Medical Officer of NovoCure Limited (NASDAQ:NVCR), Ely Benaim, Just Sold 89% Of Their Holding
.. a month old but speaks volumes ..
NWBO shares available to borrow :
Recent Data
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…So is pulling speakers last minute from conferences , in fact
I posted a few days before the 10th May horror show that If LL pulls out it means we’ve been bought …
It’s unthinkable to me that there are not high level M&A
talks going on right now.
When DMC suggested that randomization was unethical for NVCR and that they should do a shorter trial their market cap jumped from $13bn to $22bn in one trading session .
Isnt that the same signal the MHRA just gave DCVAX with regards to our PIP ...
Novocure Announces Update on Phase 3 Pivotal LUNAR Trial of Tumor Treating Fields in Non-Small Cell Lung Cancer
Pre-specified interim analysis concluded with favorable recommendation to continue the LUNAR trial
DMC stated accrual to 534 patients is likely unnecessary and possibly unethical for patients randomized to control arm and recommended a shortened trial
Novocure announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields in stage 4 non-small cell lung cancer following platinum failure. (Actor portrayal) (Photo: Business Wire)
Novocure announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields in stage 4 non-small cell lung cancer following platinum failure. (Actor portrayal) (Photo: Business Wire)
Novocure announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields in stage 4 non-small cell lung cancer following platinum failure. (Actor portrayal) (Photo: Business Wire)
Novocure announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields in stage 4 non-small cell lung cancer following platinum failure. (Actor portrayal) (Photo: Business Wire)
Novocure's Tumor Treating Fields delivery system (Photo: Business Wire)
April 13, 2021 07:30 AM Eastern Daylight Time
ST. HELIER, Jersey--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today announced an update regarding its phase 3 pivotal LUNAR trial of Tumor Treating Fields (TTFields) in stage 4 non-small cell lung cancer (NSCLC) following platinum failure. Following a routine review of the study by an independent data monitoring committee (DMC), Novocure was informed that the pre-specified interim analysis for the LUNAR trial would be accelerated given the length of accrual and the number of events observed, to date. The interim analysis included data from 210 patients accrued to the LUNAR trial through February 2021. After review of the interim analysis report, the DMC concluded that the LUNAR trial should continue with no evidence of increased systemic toxicity.
“The completion of the LUNAR interim analysis is an important milestone for Novocure”
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The DMC also stated that it is likely unnecessary and possibly unethical for patients randomized to the control arm to continue accrual to 534 patients with 18 months follow-up. The DMC recommended a reduced sample size of approximately 276 patients with 12 months follow-up which it believes will provide sufficient overall power for both primary and secondary endpoints. The DMC recommended no other changes to the design of the trial. Novocure remains blinded to all data.
The primary endpoint of the LUNAR trial is superior overall survival when patients are treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. The final analysis will also include an analysis of overall survival in the immune checkpoint inhibitor and docetaxel treatment subgroups.
Novocure has notified the U.S. Food and Drug Administration (FDA) of the DMC recommendations and of its intent to submit an Investigational Device Exemption (IDE) supplement incorporating the recommended protocol adjustments.
“We are very pleased with the DMC recommendations, which we believe support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel,” said William Doyle, Novocure’s Executive Chairman. “The accelerated interim analysis with an encouraging outcome adds to the accumulating evidence of Tumor Treating Fields’ broad potential across a range of hard-to-treat cancers.”
“Combination therapy is a cornerstone of cancer care, and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients,” continued Mr. Doyle. “We are very encouraged that, consistent with our expectations, the DMC concluded that TTFields exhibited no systemic toxicity. We will continue to develop TTFields as a limited toxicity backbone therapy upon which other standard-of-care and emerging cancer treatments can be added.”
Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. and approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. TTFields is intended principally for use together with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.
“The completion of the LUNAR interim analysis is an important milestone for Novocure,” said Asaf Danziger, Novocure’s CEO. “We are grateful to the DMC members for their diligence, guidance and support, and are looking forward to working closely with the FDA on amendments to the protocol given the DMC’s recommendations. Pending regulatory approval, the recommended protocol adjustments could accelerate trial completion by more than a year. We look forward to sharing final data from the LUNAR trial as quickly as possible.”
About LUNAR
LUNAR is a phase 3 pivotal trial testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S. The primary endpoint is superior overall survival of patients treated with TTFields plus immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone. TTFields is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.
AstraZeneca Has Two Early-Stage Cancer Drugs Approved in Japan
By Ryan Hesketh
(Bloomberg) -- AstraZeneca has Lynparza and Tagrisso approved in Japan for early breast and lung cancer, according to two statements.
AstraZeneca’s Lynparza is approved in Japan for the adjuvant treatment of patients with BRCA-mutated, HER2-negative early breast cancer at high risk of recurrence, according to a statement.
This approval by the Japanese Ministry of Health, Labour, and Welfare was based on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021
AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery
This approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the global ADAURA Phase III trial
Not anymore ...
Aek , read it again `4.5m available to....`
Short position legal : trading around 2-5m
Short position Illegal : 0
Yes I completely agree Flipper, the TLD / Journal / Global PR will lead to two immediate things :
1. HF`s and smaller institutional money joining the dots and buying in ...
2. Buy out speculation followed by a take over .
I think all the boxes are probably now all but ticked, but with 1bn shares out and even if 600m of those are locked up there`s always someone happy to de-risk / reduce on any modest move up and on such dire daily $ turnover volumes it means we are shackled to the 60c mark added to the fact that as I type there are 4.5m share available to borrow.
PIP is exactly the kind of thing institutional investors lap up, so to repeat, just one tute buyer reframes the share price in a matter if 2 or 3 trading sessions.
.
Northwest Biotherapeutics Announces Approval of Pediatric Investigation Plan (PIP) by MHRA
PR Newswire
BETHESDA, Md., Aug. 23, 2022
PIP Approval Is A Pre-Requisite for Application for Approval of A New Medicine for Adult Patients
BETHESDA, Md., Aug. 23, 2022 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the Company's Pediatric Investigation Plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for adult patients, such as DCVax®-L.
Gritstone's Cancer Drug Shows Strong Tumor-Specific Responses In Various Settings
Vandana Singh
(Benzinga Newswire)
Gritstone bio Inc (NASDAQ:GRTS) announced that interim results from the Phase 1/2 trial of GRANITE, its individualized, vaccine-based immunotherapy candidate for solid tumor cancers, were published in Nature Medicine.
Since the initiation of the Phase 1/2 study, Gritstone has followed study participants and observed increased overall survival (OS) in colorectal cancer (CRC) patients who demonstrated a molecular response versus those who did not.
As of May 2022, the median OS of this subgroup exceeded 18 months, with the median not yet reached.
This compares to a median OS of 7.8 months for patients who did not demonstrate a molecular response.
GRANITE is now being evaluated in two randomized studies in earlier-stage disease
GRANITE-CRC-1L, a Phase 2/3 trial in newly diagnosed metastatic, microsatellite-stable colorectal cancer (MSS-CRC). Initial results are expected in 2H of 2023.
GRANITE-ADJUVANT, a phase 2 study in patients with high-risk stage II/III colon cancer who are ctDNA+ after definitive surgery.
Price Action: GRTS shares closed 4.67% higher at $4.27 during after-hours trading on Monday.
Novartis canakinumab fails another phase 3 study in lung cancer
Ravikash,
Novartis (NYSE:NVS) said its medicine canakinumab (ACZ885) did not meet the main goal of disease-free survival (DFS) versus placebo in a phase 3 trial in patients with a type of lung cancer.
The study, dubbed CANOPY-A, was evaluating canakinumab as adjuvant therapy in adult patients with non-small cell lung cancer (NSCLC) stages 2-3A and 3B, whose margins are free of cancer following surgery.
DFS is the the length of time after therapy, when cancer is cleared, the patient survives without any symptoms of the disease.
The trial enrolled 1,382 patients who received either canakinumab 200-mg subcutaneously or matching placebo, every three weeks for up to one year.
In March 2021, canakinumab had failed another phase 3 trial called CANOPY-2 in patients with a certain type of lung cancer.
In June 2020, canakinumab, sold as Ilaris — an interleukin-1ß blocker — was approved by the FDA to treat adult-onset Still's disease, a rare type of inflammatory arthritis.
AstraZeneca Says Phase 3 Trial of Enhertu Met Primary Endpoint
Monday, August 15, 2022 07:08 AM
By Gabriela Mello
(Bloomberg) --AstraZeneca saw positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu (trastuzumab deruxtecan) versus physician’s choice of treatment, showing the trial met the primary endpoint, according to a filing.
Trial demonstrates a statistically significant and clinically meaningful improvement in progression-free survival PFS in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine T-DM1
It has also met the key secondary endpoint of improved overall survival
Flip - I`ve had many conversations with MHRA , one in particular is by far the most relevant.
I was told like any business there are always delays and 150 calendar days is the goal they aim for but and I quote `if a company is seeking approval for treatment of a life threatening condition you would get a far more dynamic review that for a topical acne cream `
Nothing surprising about that but it was good to hear common sense being spoken from a relevant person at the relevant department.
Flipper , would you mind taking a look at this and letting us know your
view pse :
meirluc
RE: flipper44 post# 503177
Post#
503215
of 503422
Tuesday, 08/09/2022 08:08:06 PM
Flipper, I realize that the inclusion/exclusion criteria in our trial most likely excluded more pseudo progressors than the ECAs. Was that enough to validate a comparison between the ECAs rGBM patients and the relatively robust 64 crossover patients in our trial?
Merck’s Januvia Found To Contain Potential Carcinogen (2)
Impurity was detected in Merck’s sitagliptin-containing drugs
The FDA said it is working to avoid shortages of the drugBy Anna Edney
(Bloomberg) -- Merck & Co.’s Januvia, a popular diabetes drug, was found to be contaminated with a potential carcinogen.
An impurity called a nitrosamine was found in some samples of the drug, which has the chemical name of sitagliptin, the US Food and Drug Administration saidTuesday. The agency said it was permitting Merck to continue to sell drugs containing sitagliptin with higher-than-allowed levels of nitrosamine in order to avoid shortages.
Merck confirmed in an email that it “recently detected a nitrosamine identified as NTTP in some batches of our sitagliptin-containing medicines.” The company is working with health authorities around the world and has put in place additional quality controls to make sure the drugs meet the FDA’s interim limits.
Merck confirmed it found NTTP in three drugs that contain sitagliptin: Januvia, Janumet and Steglujan. Nitrosamine levels in a related extended-release therapy, Janumet XR, were too low to be measured, Merck said.
Januvia is Merck’s third best-selling drug with $3.3 billion in sales last year, according to Bloomberg data. Janumet had revenue of almost $2 billion last year.
Sitagliptin, used to control high blood sugar in patients with type 2 diabetes, is one in a string of medications found to be contaminated with nitrosamines since 2018. Another popular diabetes drug called metformin was among those affected, along with certain blood pressure pills and Pfizer Inc.’s smoking cessation drug, Chantix.
Four years ago, pharmaceutical companies discovered that some blood pressure pills were tainted with N-Nitrosodimethylamine, or NDMA, kicking off a years-long examination of commonly used medicines that uncovered several instances of contamination. NDMA likely can increase the risk of cancer after prolonged exposure at the levels detected in the drugs.
Merck shares fell as much as 1.9% following news of the FDA statement, but recovered to gain 1.2% at the New York close.
Read More: Carcinogens Have Infiltrated the Generic Drug Supply in the US
The nitrosamine discovered in sitagliptin is called Nitroso-STG-19, or NTTP.
“Although there are no data available to directly evaluate the carcinogenic potential of NTTP, FDA used information available on closely related nitrosamine compounds to calculate lifetime exposure limits for NTTP,” the agency said.
The FDA allows 37 nanograms per day of nitrosamine in a drug, though it is allowing up to 246.7 nanograms in sitagliptin to avoid shortages. The agency said that its calculations show the difference in cancer risk is minimal.
“We remain confident in the safety, efficacy and quality of our sitagliptin-containing medicines,” Merck said. “No significant impact on supply of these medicines for patients is anticipated.”
The FDA recommended patients continue on their sitagliptin drugs until they talk to a health-care provider.
“FDA recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment,” according to the agency.
Pfizer to Buy Global Blood Therapeutics in $5.4 Billion Deal (2)
Pharma giant will gain treatment for sickle-cell disease
Global Blood shares jumped last week on takeover speculationBy Riley Griffin
(Bloomberg) -- Pfizer Inc. has agreed to buy Global Blood Therapeutics Inc., the maker of a drug for sickle-cell disease, in a deal worth $5.4 billion.
The New York drug giant will pay $68.50 for all outstanding shares of Global Blood, the companies said Monday in a statement. That’s double the price of the stock on Aug. 3, when Bloomberg reported the company was drawing takeover interest. The total equity value of the deal excluding debt is about $4.6 billion, according to Bloomberg calculations.
Both boards unanimously approved the transaction. Pfizer will gain Oxbryta, South San Francisco, California-based Global Blood’s therapy for sickle-cell disease that sold about $195 million last year and the companies see as a potential blockbuster. Pfizer needs new products as concerns about the pandemic wane, threatening revenue from its top-selling Covid-19 vaccine and its pill to treat the disease, Paxlovid.
“Pfizer has been clear that a large portion of its Covid-19 vaccine and tablet windfall will be invested to accelerate top-line growth -- targeting the addition of at least $25 billion of risk-adjusted revenue to 2030 expectations,” Bloomberg Intelligence analysts John Murphy and Sam Fazeli wrote in a note. “Consensus calls for GBT sickle-cell disease-therapy sales of around $1 billion in 2026, which will boost Pfizer’s rare-disease business. Further deals are expected to be announced.”
Merck & Co.'s Keytruda Fails To Extend Survival In Liver,
(MT Newswires)
Merck & Co. (MRK.PA) said Wednesday that its blockbuster immunotherapy Keytruda did not meet the main goals of two late-stage studies after failing to prolong the lives of patients with hepatocellular carcinoma and prostate cancer.
The phase 3 trial called Leap-002 evaluated Keytruda combined with Eisai's Lenvima as a first-line treatment for people with unresectable hepatocellular carcinoma. Meanwhile, the late-stage Keynote-921 trial examined Keytruda plus chemotherapy docetaxel for treating patients with metastatic castration-resistant prostate cancer.
In both studies, they were trends toward improvements in overall survival among the patients who received the Keytruda combination therapies. The results, however, were not statistically significant as stated in pre-specified statistical plans.
Anything PR'd by the company will be published as news on Bloomberg .
Any kind of strategic partnership would also be covered in the strategic partners news and there's where a far wider professional readership would occur and also get coverage from industry journos who's article would then appear under news for both parties again ... and so on and so forth ..
'MHRA Accepts, Big Fish Takes a Stake' would get very wide coverage indeed .
But the official legally binding ` met end points PR ` must come first...
oops yep you`re correct but the point I was really making and stand by 100% is PPS means nothing when there`s been continual dilution and M/C is all that counts when comparing with any other stock or index ..
WHATEVER ... BYYEEEEE
PPS is totally irrelevant
M/c is :
5 years + 1818%
2 years +1%
YTD -27%
Thanks for the heads up Steve.
Great info.
Keyourmars 100% says `APPROVED `
I wish - but Merck SGEN will def close , just due diligence box ticking holding things up.
The SGEN revs could service the debt from day 1, so net net another sizable buy for Merck is not off the table seeing as NWBO is so tiny there's zero integration issues.
Merck Has Good Reason to Buy a Cancer-Drug Biotech: Lisa Jarvis
Seagen’s innovative technology for delivering chemotherapy is blossoming.By Lisa Jarvis
(Bloomberg Opinion) -- Merck & Co. has said nothing publicly about rumors that it is in talks to buy Seagen, a biotech company working on cancer treatments, for about $40 billion.
But Seagen has laid out a strong case for the idea. The 25-year old biotech’s cancer-drug technology is finally coming to fruition.
Seagen is working at the center of a renaissance in so-called antibody-drug conjugates — a class of medicines created by tacking powerful chemotherapy agents onto antibodies that can carry them directly to tumor cells. The idea is that, by releasing the chemo precisely where it’s needed, the drugs might not cause nasty side effects, even if rather toxic chemo is used.
It’s a simple concept that has taken decades to perfect. Of the 12 antibody-drug conjugates to receive Food and Drug Administration approval by the end of 2021, nine have gotten the green light just since 2017.
Biotech companies have finally come to understand the formula for putting the complex molecules together, by choosing the ideal antibodies and chemo agents and figuring out the best ways to connect them.
The new drugs are clearly making a difference in treating cancer. At a recent oncology meeting, data from a clinical trial of an antibody-drug conjugate called Enhertu, developed by AstraZeneca and Daiichi Sankyo, was deemed practice-changing for certain patients with metastatic breast cancer. These data reinforced a sense among oncologists that, for certain types of cancer, antibody-drug conjugates could start to replace conventional chemo.
The results also suggest that this class of drugs could be used much more broadly than thought — a notion that Seagen is exploring with its own portfolio of drugs. This was part of a strong case that company executives laid out in their second-quarter earnings call for expanding the use of Seagen’s four approved drugs. They also noted how these drugs complement Keytruda, Merck’s own immuno-oncology treatment.
Seagen last week showed that combining its drug Padcev with Keytruda shrank tumors in about 65% of people with a certain kind of bladder cancer. Such positive, if early, data is viewed as critical to sealing a deal between the companies.
There’s another reason that buying Seagen would be a smart move for Merck: Those better-built antibody-drug conjugates could be very hard to duplicate. Manufacturing such complex treatments is tricky, and that might stave off generic competition — an appealing proposition for any suitor looking for lasting revenue streams.
For Merck, the appeal could be especially great, because starting in 2028 the company could face competition from the first generic versions of Keytruda, a drug that has become increasingly critical to its financial fate. In the second quarter of 2022, it brought in $5.3 billion, or about 36% of the company’s total revenues of $14.5 billion for the period. Although Merck is developing a subcutaneous version of the currently intravenously administered drug, a delivery format the company believes will get patent protection, alternate revenue streams still will be essential to maintaining its business.
Merck is reportedly delaying its decision on buying Seagen until it learns the resolution of its patent litigation with Daiichi over a component of its antibody-drug conjugate technology. Money certainly hangs in the balance, but the long-term potential of Seagen’s portfolio makes this a deal worth getting done.
Innate Pharma Slumps; AstraZeneca Ends a Monolizumab Study (1)
By Leonard Kehnscherper and Phil Serafino
(Bloomberg) -- (Updates with stock decline in first paragraph.)
Innate Pharma fell as much as 22% after AstraZeneca ended a study of the company’s monalizumab in head and neck cancer, saying an early analysis indicated the medicine wasn’t effective.
Stock declines 17% to EU2.52 at 9:12 a.m. in Paris, extending YTD drop to 43%
Interim analysis of the Interlink-1 Phase 3 study sponsored by AstraZeneca didn’t meet a threshold for efficacy, according to a statement
AstraZeneca informed Innate the study will be discontinued
“We remain confident in the development program for monalizumab in lung cancer, where encouraging data has been previously reported,” said Mondher Mahjoubi, CEO of Innate Pharma