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Hullo! Turns out Jay Bradner is moving from academia and Novartis to serve as Amgen’s new CSO. Also, the FDA has a new registry of trial sponsors and investigators who didn’t finish their paperwork. Have a nice weekend!
Is no one safe from the FTC?
Has Pfizer bottomed out? And is biotech finally back? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast.
First, we delve into the fallout over the FTC’s move to block what looked like a humdrum biotech deal between Sanofi and Maze Therapeutics, a surprising twist that leaves unanswered question. We also discuss the latest news in the life sciences, including Pfizer’s downbeat future, Vertex Pharmaceuticals’ next big thing, and a newly minted biotech VC with a very famous name.
Novartis vet joins as Amgen CSO
A former top research exec at Novartis is moving over to Amgen as its chief scientific officer. Jay Bradner will now oversee Amgen’s pipeline, whose assets are mostly in oncology, immunology, rare disease, and biosimilars. Bradner joined Novartis in 2016, leading its Cambridge, Mass.-based Institutes for Biomedical Research. Before that, he’d spent a decade on the faculty of Harvard’s Dana-Farber Cancer Institute. He left Novartis in September 2022 to work at Dana-Farber again, but has bounced back to industry again.
Bradner will take over the role of Amgen vet David Reese, who will become the company’s chief technology officer and oversee how artificial intelligence is deployed.
A dashboard of shame for delinquent trial documentarians
The FDA has launched a new dashboard that stores the preliminary notices sent to companies, universities, and researchers that didn’t register their clinical trials or report study results. Regulators have sent about 120 of these “pre-notices” to investigators who didn’t complete these steps. If they aren’t addressed, the FDA can levy penalties against errant trial sponsors or investigators. Among the recipients of these pre-notices are Novartis, Bausch and Lomb, and the Georgetown University Medical Center.
This matters because without access to specific data, trial results can’t be replicated — which is an important step in understanding how medicines work. Missing information can also impact treatment decisions and health care costs.
FDA chastens pet companies over antibiotics
The FDA has warned nine online pet suppliers, including Chewy, for carrying “illegally marketed” over-the-counter antimicrobial medicines — including penicillin, amoxicillin, tetracycline, and erythromycin. Regulators said that humans might be using some of the antimicrobials being sold online for pets — much like the pandemic trend of buying ivermectin online, Forbes writes. The primary concern is that unmitigated use of these medicines could further spike antibiotic resistance.
The suppliers have been given 15 days to respond to the agency with a plan to remove these medicines, or could face legal action or have their products taken away.
More reads
- Obesity meets its match, Science
- Renee Pharmaceuticals cuts 70% of workforce as mavodelpar study misses endpoints, MarketWatch
- Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns, FiercePharma
- PwC: Biotech IPO window will ‘gradually reopen’ in 2024 as M&A remains ‘healthy’, FierceBiotech