Califf describes ideal candidate for FDA commish

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Nov 13, 2024
 

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Adaptimmune gears up for another FDA submission after hitting goal in pivotal sarcoma study

Adaptimmune Therapeutics is prepping for another FDA submission after 42% of patients with sarcoma responded to the company's investigational cell therapy in a pivotal phase 2 trial.
 

Top Stories

BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink

As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in acquiring external products with the potential to launch in the near term, according to a new loss of exclusivity report from Leerink Partners.

After election, FDA's Califf lays out hopes for his Trump-appointed successor

The current FDA commissioner said that Trump’s first FDA head, Scott Gottlieb, was the perfect choice at the time.

Hidden data on obesity prospect wipe $12B off Amgen market cap

A hidden tab in an Excel spreadsheet published nine months ago has wiped $12 billion off Amgen’s market cap. The tab contains data on bone density changes in patients who received Amgen’s obesity prospect MariTide in a phase 1 trial.

Caris scores FDA approval for multi-cancer companion diagnostic test

The company describes the precision medicine test as the first of its kind to offer simultaneous whole exome sequencing and whole transcriptome sequencing.

BioNTech pays $800M to take control of potential Keytruda killer

BioNTech is upping its bet on a PD-L1xVEGF-A bispecific, paying $800 million upfront to buy its Chinese partner Biotheus and secure full rights to a leading prospect in the white-hot immuno-oncology space.

Bayer's rising prostate cancer star Nubeqa crosses blockbuster barrier as Xarelto continues downward descent

As Xarelto generics continue to eat away at sales, Bayer's Nubeqa and Kerendia are picking up the slack while Regeneron-partnered Eylea makes for a solid base.

Zimmer gives Schwarzenegger C-suite title for push to terminate immobility

Zimmer Biomet has hired The Terminator to tell the world that “if you rest, you rust.” The manufacturer of orthopedic medtech products is getting its message about how to increase mobility and maintain joint health out via its newly appointed chief movement officer: Arnold Schwarzenegger.

Marinus cuts 45% of staff after key medicine stumbled in pair of phase 3 trials

The company last month opted to end development of its flagship seizure drug while exploring "strategic alternatives" to maximize shareholder value ahead of a planned FDA meeting.

Syros flunks phase 3 blood cancer trial, triggering loan default and share-price plunge

Syros Pharmaceuticals’ blood cancer prospect tamibarotene has failed another study, triggering a default on a loan and wiping 85% off the share price of the beleaguered biotech.

GE HealthCare inks collab with RadNet in mammography AI

GE HealthCare tapped imaging provider RadNet for an artificial intelligence collaboration aimed at reshaping the radiology diagnostic workflow.
 
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Dig into this year’s Fierce Biotech Graveyard, layoff numbers

This week on "The Top Line," we take a closer look at this year’s biotech graveyard, which tracks biotechs that have closed or are winding down. 
 

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