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Jul 28, 2023

Biogen, working through a 'transition,' plots 1,000 more layoffs by 2025


J&J’s shrinking infectious disease and vaccine plans leave partners in limbo


GSK’s Arexvy to lead new RSV vaccines sales race with Moderna a close second: report


Ex-B. Braun regulatory specialist pleads guilty to forging FDA clearance documents


Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval


Biogen CEO’s tight-lipped zuranolone commentary not enough for Sage investors

 

Featured

Biogen, working through a 'transition,' plots 1,000 more layoffs by 2025

In a sizable cost-cutting measure, Biogen will lay off 1,000 employees by 2025, it announced in presenting its second quarter earnings. With the company starting 2023 with 8,725 employees, that’s an 11.5% reduction of the workforce.
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Top Stories

J&J’s shrinking infectious disease and vaccine plans leave partners in limbo

Cidara Therapeutics has yet to hear whether Janssen is formally ending a collaboration on flu prophylaxis, saying it intends to trudge ahead with development until hearing otherwise. Janssen no longer lists the partnered asset in its pipeline.

GSK’s Arexvy to lead new RSV vaccines sales race with Moderna a close second: report

We waited years for working RSV vaccines and in 2023, in the space of just a few weeks, we had two come all at once, with another on the horizon and a fresh approval for an RSV prevention med.

Ex-B. Braun regulatory specialist pleads guilty to forging FDA clearance documents

A regulatory affairs specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market.

Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval

The U.S. Food and Drug Administration has added a fourth dose of Lilly’s popular new diabetes med to its drug shortage database. The agency also expects supply issues with three other doses to persist longer than previously thought.

Biogen CEO’s tight-lipped zuranolone commentary not enough for Sage investors

Analysts and investors wanted the tea on the FDA review of Sage Therapeutics’ zuranolone, but Biogen CEO Chris Viehbacher wouldn’t spill it.

Pfizer, FDA work to ease shortage concerns as tornado relief efforts pick up at NC injectables plant

Pfizer on Friday said it kicked off “immediate efforts” to provide relief and repair to the damage caused to its manufacturing facility in Rocky Mount, North Carolina. It noted crews are working around the clock to restore power, assess the structural integrity of the building and to relocate finished medicines to nearby sites for storage.

Gilead’s $4.9B CD47 bet faces latest setback as company cans MDS ambitions for magrolimab

Gilead’s $4.9 billion bet on Forty Seven has run into further trouble, with the Big Pharma pulling the plug on its myelodysplastic syndromes (MDS) ambitions for the lead CD47 asset from that deal in the face of a disappointing phase 3 trial.

Centaur Pharmaceuticals slapped with FDA warning letter outlining quality, cleaning lapses

In a warning letter published late last week, the FDA chided Centaur for production shortfalls found during a November 2022 inspection of the company’s Maharashtra, India, drug ingredients plant. The rebuke centered on just two observations about quality deficiencies and lapses in cleaning protocols. The latter problem carried the risk of API contamination, the FDA said.

To prevent cancer metastasis, prevent protein migration, new study suggests

Unexpected findings about how cell stress impacts gene expression have brought researchers a step closer to solving one of the many mysteries of cancer metastasis—and, potentially, to new ways to prevent it.
 
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'The Top Line': A special episode on Narcan, the life-saving nasal spray

This week on "The Top Line," we revisit an episode on Narcan the nasal spray. It is the first naloxone product to be approved for use without a prescription.
 

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