News
The FDA currently does not recommend using changes in lean mass as an endpoint in clinical trials for weight loss drugs. Should it?
FEATURED STORIES
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
Job Trends
BridgeBio Pharma, Inc. and Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company focused on bringing innovative therapies to patients living with rare diseases owned by Zydus Lifesciences Ltd., announced the execution of an asset purchase agreement for the sale of BridgeBio’s NULIBRY™ for Injection.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
THE LATEST
Continuing its clinical win streak, AbbVie’s Skyrizi showed signs of superiority against Johnson & Johnson’s Stelara in topline data from a head-to-head Phase III Crohn’s disease study.
Topline data for the company’s CRF1 antagonist crinecerfont showed a significant drop in daily glucocorticoid dose, while maintaining androgen control in adult patients with the genetic disorder.
The agency’s briefing document found Phase III results investigating patisiran’s effects versus placebo were “small, of questionable clinical meaningfulness, and may not be detectable by patients.”
Citing a challenging macro environment, 2seventy bio is launching a sweeping strategic reorganization that will see 40% of its staff laid off and CEO Nick Leschly stepping down.
As the Novartis generics and biosimilars division nears its spin-off, Sandoz has signed a commercialization agreement with Samsung Bioepis, gaining rights to the latter’s Stelara biosimilar.
Following a $540 million IPO in May, Acelyrin’s lead candidate izokibep failed to meet the primary endpoint in a Phase IIb/III study of patients with the chronic inflammatory skin condition.
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
The collaboration, which includes an upfront payment of $120 million to Immatics, pairs Moderna’s mRNA technology with Immatics’ T-cell receptor platform for cancer treatment.
Following a Phase II review, Novartis has cut the development of a gene therapy candidate for geographic atrophy. In June, the company sold a dry eye disease drug to Bauch + Lomb for $1.75 billion.
The California pharma is building up to its first-ever approval with promising late-stage data for its once-daily investigational acromegaly pill paltusotine, an alternative to the injectable standard of care.