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Hullo! Seems Jay Bradner is transferring from academia and Novartis to function Amgen’s new CSO. Additionally, the FDA has a brand new registry of trial sponsors and investigators who didn’t end their paperwork. Have a pleasant weekend!
Is nobody protected from the FTC?
Has Pfizer bottomed out? And is biotech lastly again? We cowl all that and extra this week on “The Readout LOUD,” STAT’s biotech podcast.
First, we delve into the fallout over the FTC’s transfer to dam what seemed like a humdrum biotech deal between Sanofi and Maze Therapeutics, a stunning twist that leaves unanswered query. We additionally focus on the newest information within the life sciences, together with Pfizer’s downbeat future, Vertex Prescription drugs’ subsequent large factor, and a newly minted biotech VC with a really well-known identify.
Hear right here.
Novartis vet joins as Amgen CSO
A former prime analysis exec at Novartis is transferring over to Amgen as its chief scientific officer. Jay Bradner will now oversee Amgen’s pipeline, whose property are largely in oncology, immunology, uncommon illness, and biosimilars. Bradner joined Novartis in 2016, main its Cambridge, Mass.-based Institutes for Biomedical Analysis. Earlier than that, he’d spent a decade on the school of Harvard’s Dana-Farber Most cancers Institute. He left Novartis in September 2022 to work at Dana-Farber once more, however has bounced again to business once more.
Bradner will take over the position of Amgen vet David Reese, who will turn out to be the corporate’s chief expertise officer and oversee how synthetic intelligence is deployed.
A dashboard of disgrace for delinquent trial documentarians
The FDA has launched a brand new dashboard that shops the preliminary notices despatched to corporations, universities, and researchers that didn’t register their scientific trials or report examine outcomes. Regulators have despatched about 120 of those “pre-notices” to investigators who didn’t full these steps. In the event that they aren’t addressed, the FDA can levy penalties towards errant trial sponsors or investigators. Among the many recipients of those pre-notices are Novartis, Bausch and Lomb, and the Georgetown College Medical Middle.
This issues as a result of with out entry to particular information, trial outcomes can’t be replicated — which is a crucial step in understanding how medicines work. Lacking info can even affect remedy choices and well being care prices.
FDA chastens pet corporations over antibiotics
The FDA has warned 9 on-line pet suppliers, together with Chewy, for carrying “illegally marketed” over-the-counter antimicrobial medicines — together with penicillin, amoxicillin, tetracycline, and erythromycin. Regulators mentioned that people is perhaps utilizing a number of the antimicrobials being offered on-line for pets — very similar to the pandemic development of shopping for ivermectin on-line, Forbes writes. The first concern is that unmitigated use of those medicines might additional spike antibiotic resistance.
The suppliers have been given 15 days to answer the company with a plan to take away these medicines, or might face authorized motion or have their merchandise taken away.
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