Tristan Mañalac

6 days ago | biospace.com | Tristan Mañalac

Sanofi has turned its back on its partner IGM Biosciences, forcing the small California biotech to enact drastic strategic measures, including an 80% reduction in force. IGM made the announcement in an SEC document on Thursday, noting that Sanofi had informed it of the decision to walk away on Monday. The contract will formally end 30 days after the notice.

6 days ago | biospace.com | Tristan Mañalac

In a bid to support regulatory review, the FDA expects to deploy artificial intelligence across all of its centers by the end of June, the agency announced Thursday. The announcement comes as the FDA completes its pilot scientific review using a generative AI model. “I was blown away by the success of our first AI-assisted scientific review pilot,” Commissioner Marty Makary said in a statement on Thursday, though the agency did not provide specific details about the project.

6 days ago | biospace.com | Tristan Mañalac

The FDA has missed another target decision date, this time for GSK, which is looking to expand its IL-5 blocker Nucala into chronic obstructive pulmonary disease. As per a December 2024 press release from GSK announcing the FDA’s acceptance of its application, the regulator should have released a verdict on Wednesday, May 7. But several media outlets on Thursday reported that an announcement has yet to be made.

6 days ago | biospace.com | Tristan Mañalac

Rallybio is laying off nine employees, about 40% of its total headcount, as it reels from the loss of its lead asset, the biotech announced in its first-quarter earnings report on Thursday. The terminations will be “substantially complete” by the end of the second quarter, according to the press release. Rallybio expects to absorb roughly $1.7 million in one-time costs, primarily linked to severance and benefit payments. This sum, however, still excludes share-based compensations.

1 week ago | biospace.com | Tristan Mañalac

Later this month, the FDA will convene its external vaccine advisors to decide on the formulation for COVID-19 vaccines to be used in the upcoming 2025-2026 season, according to a Federal Register notice posted Thursday. The meeting is scheduled for May 22. Importantly, Federal Register notices should go live at least 15 days before the scheduled meeting. In this case, the announcement should have been posted on Wednesday, May 7.