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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
JPM
With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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The rare disease space is awaiting two FDA verdicts in February, one for a genetic disease and another for a non-malignant tumor.
Several companies—including JCR Pharmaceuticals, Denali Therapeutics and Regenxbio—have products in the pipeline that could improve treatment options for this rare disease.
FDA
Robert F. Kennedy, Jr.—Trump’s pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA, particularly financial links between the two, which could indicate trouble for the user-fee model.
After the Phase II failure of its lead asset from Cerevel, AbbVie is resetting expectations and narrowing the clinical program to an adjunct approach—for now.
ImmunityBio will part with 10 employees this quarter. Last fall, it cut 31 employees. The moves come as the biotech works to advance Anktiva in non-small cell lung cancer.
IRA
While the former Biden administration showcased the Inflation Reduction Act as a key victory in the fight over high drug prices in the U.S., Trump has so far been mum on how the controversial law could evolve in the coming years.
Fractyl Health is deprioritizing a type 2 diabetes trial in favor of a pivotal study of its endoscopy treatment Revita and parting with around 22 employees in an attempt to extend its runway into 2026.
Biogen’s effort to buy Sage against the board’s wishes and a long-time effort by investor Alcorn to scuttle Aurion’s IPO underscore the cutthroat nature of biopharma dealmaking.
The approval of Axsome Therapeutics’ Symbravo for migraine with or without aura came alongside the greenlight for Vertex’s non-opioid treatment Journavx.
Novartis was among the most prolific pharma dealmakers in 2024, a trend that it expects to continue with more bolt-on deals this year to set up for sustainable long-term growth.