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STAT+: Pharmalittle: We’re reading about Sanofi and an FDA voucher, FDA rethinking a rejection, and more
Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …
Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff.
An experimental drug from Revolution Medicines that nearly doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate of mostly low-grade side effects, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.
Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …
Sanofi asked the U.S. Food and Drug Administration to pull its type 1 diabetes drug, teplizumab, out of FDA Commissioner Marty Makary’s new speedy review program, STAT reports. The move comes after acting Center for Drug Evaluation and Research Director Tracy Beth Høeg disagreed with a staff decision to approve the drug. The agency missed its April 21 goal date to deliver a decision to Sanofi. Such decisions are typically made by career scientists. It is rare for a center director to become involved in scientific review of a single drug, and particularly a political appointee like Høeg. Makary recently said that he stands behind review teams, and that “disaster” occurs whenever political leaders overrule scientific staff.
An experimental drug from Revolution Medicines that nearly doubled survival time for patients with advanced pancreas cancer in clinical trials comes with a high rate of mostly low-grade side effects, Reuters tells us. A report by researchers from a first-in-human trial of daraxonrasib is the first peer-reviewed paper to show safety data for what analysts say could become the next standard of care for previously treated metastatic pancreatic cancer. Among the 168 patients with previously treated pancreatic ductal adenocarcinoma who received daraxonrasib in the early trial, treatment-related adverse side effects of any grade occurred in 96%, while severe or life-threatening events were reported in 30%.
EnGene’s latest Phase 2 results on an experimental treatment for certain bladder cancer patients alarmed investors and raised concerns around the therapy’s future prospects.
The Canadian biotech’s shares {$ENGN} fell 80% Thursday morning after reporting …
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Angelini to buy Catalyst in $4B play for rare neuro drugs
The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.
The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market access in the U.S.
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FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit
The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
EnGene’s shares crash on updated pivotal bladder cancer data
Angelini to buy Catalyst in $4B play for rare neuro drugs
FDA reverses course on Atara, Pierre Fabre’s twice-rejected cell therapy after Prasad’s exit
STAT+: More political interference at the FDA?
Angelini inks $4.1B Catalyst buy to enter US rare disease market
Gilead wipes out most of Arcellx workforce
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
Mod turns ‘Counter-Strike’ into a ‘Tekken’ clone with fighting chickens
Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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