Cassandra X floated an interesting idea in post 118524 that CYDY might not be on the path of a partnership or BO. While that is certainly a possibility, there are probably several pharmas looking to see what is available because of recent problems with their trials. No matter what path CYDY is on, it should be constructive if some companies do make inquiries. It would at least expand Dr. Kelly’s Rolodex (are they still used?) for possible future opportunities. Note that these examples include drugs for Covid, Alzheimer’s, and cancer, as well as an anti-inflammatory drug.
EMA might deny Merck's molnupiravir conditional marketing authorization
While Merck’s Covid-19 antiviral molnupiravir has been given EUA in the US, it has still been pending authorization in Europe. And in a new report from the Financial Times, the EMA might not recommend granting conditional marketing authorization — potentially shutting Merck’s antiviral out of one of the world’s largest drug markets.
People familiar with the approval process told the news organization that the EMA is unlikely to grant conditional marketing authorization to Merck’s Covid-19 antiviral as it wrestles with “problematic” data.
It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, one of the people said.
https://endpts.com/ema-might-deny-mercks-moln...on-report/
A new analyst report spotlights 3 more deaths, ARIA among Alzheimer's patients taking Aduhelm
A prominent Wall Street analyst is delving back into the agency’s adverse event database, identifying 3 additional deaths among patients taking the controversial Alzheimer’s drug Aduhelm — though he’s careful to add that there is no conclusive link between the drug and any deaths in this group so far.
Brian Abrahams at RBC, who’s stirred up some controversy with an initial report of a patient death back in November, also ran some numbers on the reports of ARIA seen among these patients in an effort to tease out just how dangerous this drug may be when used in the real world, as opposed to the carefully monitored clinical trials Biogen used to initially test its safety and efficacy. ARIA involves brain swelling and microbleeds that could threaten patients, though Biogen researchers have insisted that it’s a safety signal that can be monitored and treated in practice.
These reports have raised a big issue for Biogen as it’s struggled to gain traction in the market with one of the most controversial therapies ever green-lighted by the FDA. Critics, and there’s a legion of them, have maintained that Biogen never came close to producing the kind of clear efficacy data that would warrant an accelerated approval. If the drug also proves a definite threat, it could push regulators to reconsider the approval.
https://endpts.com/a-new-analyst-report-spotl...g-aduhelm/
FDA starts probe into a clinical trial death as next-gen CAR-T researchers stop enrollment
Pushing the envelope on next-gen CAR-T drugs, researchers running an early-stage trial on a 2.0-style cancer therapy at Memorial Sloan Kettering Cancer Center have hit the red light on enrollment for now as they probe the recent death of a mesothelioma patient. The trial pause centers on a drug advanced by Atara Biotherapeutics, which struck a $670 million collaboration deal on two mesothelioma projects — including this one — with Bayer at the end of 2020.
In an SEC filing, Atara notified investors that the MSK team halted enrollment on ATA2271, an autologous therapy — where cells are taken from patients and tweaked into attack vehicles — that had passed its first safety test. This portion of the test involves small cohorts of patients getting escalated doses of the cell treatment, a standard trial design in oncology.
https://endpts.com/fda-starts-probe-into-a-cl...nrollment/
In surprise flop, Regeneron, Sanofi report Dupixent PhIII failure, triggering premature trial stop
Dupixent, the seemingly infallible anti-inflammatory drug jointly developed by Regeneron and Sanofi, has flopped in a Phase III study.
Given to patients with chronic spontaneous urticaria — a condition characterized by the constant presence of hives — Dupixent failed to reach statistical significance on the primary endpoints of reducing itch and hives at an interim analysis.
Regeneron and Sanofi said the trial will be stopped due to futility.
The announcement marks a rare setback for the Dupixent program, a reliable megablockbuster that’s been racking up positive readout after positive readout, steadily expanding its label and drawing the envy of multiple challengers both in the startup and pharma world.
https://endpts.com/in-surprise-flop-regeneron...rial-stop/
EMA might deny Merck's molnupiravir conditional marketing authorization
While Merck’s Covid-19 antiviral molnupiravir has been given EUA in the US, it has still been pending authorization in Europe. And in a new report from the Financial Times, the EMA might not recommend granting conditional marketing authorization — potentially shutting Merck’s antiviral out of one of the world’s largest drug markets.
People familiar with the approval process told the news organization that the EMA is unlikely to grant conditional marketing authorization to Merck’s Covid-19 antiviral as it wrestles with “problematic” data.
It is “possible” that the oral Covid drug molnupiravir will not receive approval at all, one of the people said.
https://endpts.com/ema-might-deny-mercks-moln...on-report/
A new analyst report spotlights 3 more deaths, ARIA among Alzheimer's patients taking Aduhelm
A prominent Wall Street analyst is delving back into the agency’s adverse event database, identifying 3 additional deaths among patients taking the controversial Alzheimer’s drug Aduhelm — though he’s careful to add that there is no conclusive link between the drug and any deaths in this group so far.
Brian Abrahams at RBC, who’s stirred up some controversy with an initial report of a patient death back in November, also ran some numbers on the reports of ARIA seen among these patients in an effort to tease out just how dangerous this drug may be when used in the real world, as opposed to the carefully monitored clinical trials Biogen used to initially test its safety and efficacy. ARIA involves brain swelling and microbleeds that could threaten patients, though Biogen researchers have insisted that it’s a safety signal that can be monitored and treated in practice.
These reports have raised a big issue for Biogen as it’s struggled to gain traction in the market with one of the most controversial therapies ever green-lighted by the FDA. Critics, and there’s a legion of them, have maintained that Biogen never came close to producing the kind of clear efficacy data that would warrant an accelerated approval. If the drug also proves a definite threat, it could push regulators to reconsider the approval.
https://endpts.com/a-new-analyst-report-spotl...g-aduhelm/
FDA starts probe into a clinical trial death as next-gen CAR-T researchers stop enrollment
Pushing the envelope on next-gen CAR-T drugs, researchers running an early-stage trial on a 2.0-style cancer therapy at Memorial Sloan Kettering Cancer Center have hit the red light on enrollment for now as they probe the recent death of a mesothelioma patient. The trial pause centers on a drug advanced by Atara Biotherapeutics, which struck a $670 million collaboration deal on two mesothelioma projects — including this one — with Bayer at the end of 2020.
In an SEC filing, Atara notified investors that the MSK team halted enrollment on ATA2271, an autologous therapy — where cells are taken from patients and tweaked into attack vehicles — that had passed its first safety test. This portion of the test involves small cohorts of patients getting escalated doses of the cell treatment, a standard trial design in oncology.
https://endpts.com/fda-starts-probe-into-a-cl...nrollment/
In surprise flop, Regeneron, Sanofi report Dupixent PhIII failure, triggering premature trial stop
Dupixent, the seemingly infallible anti-inflammatory drug jointly developed by Regeneron and Sanofi, has flopped in a Phase III study.
Given to patients with chronic spontaneous urticaria — a condition characterized by the constant presence of hives — Dupixent failed to reach statistical significance on the primary endpoints of reducing itch and hives at an interim analysis.
Regeneron and Sanofi said the trial will be stopped due to futility.
The announcement marks a rare setback for the Dupixent program, a reliable megablockbuster that’s been racking up positive readout after positive readout, steadily expanding its label and drawing the envy of multiple challengers both in the startup and pharma world.
https://endpts.com/in-surprise-flop-regeneron...rial-stop/
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