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FDA Commissioner Marty Makary called these changes âcommon-sense reformsâ that could expedite the development of cell and gene therapies.
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After years stuck in the âdoldrums,â the biopharma sector is in a âvery good placeâ heading into the new year, analysts told BioSpace, with both rare and chronic diseases headlining investor and R&D interest as JPM26 kicks off.
Pharmas will need to provide their latest stance on the Most Favored Nation drug pricing plans, while biotech finally gets a break after a few tough years.
From biotech veterans to embattled modalities to a new wave of RNAi therapeutics, BioSpaceâs NextGen Class of 2026 emerged during a tough fundraising environment in 2025. Check out the 15 battle-tested companies that caught our eye.
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With five CDER leaders in one year and regulatory proposals coming âby fiat,â the FDA is only making it more difficult to bring therapies to patients.
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FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDAâs priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Instead of homing in on PSMAâcurrently the most validated target in prostate cancerâBMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The companyâs intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an âimmediate reversalâ of the HHS Secretaryâs decision to oust all 17 members of the CDCâs vaccine advisory board.
The layoffs will heavily affect Vertexâs operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmedâs Phase IIb readout âimpressive across the board,â with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharmaâs amylin efforts underwhelmed investors.
The deal is Lillyâs second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins.
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDCâs Advisory Committee on Immunization Practices; Metseraâs amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
Some companiesâ preferences for people who already have industry experience and the tough job market are among the hurdles those just starting out in biopharma must navigate, two recruitment experts told BioSpace.