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Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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The downsizing comes after a year of workforce cuts and reorganization for Roche’s subsidiary.
FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDA’s priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Instead of homing in on PSMA—currently the most validated target in prostate cancer—BMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The company’s intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an “immediate reversal” of the HHS Secretary’s decision to oust all 17 members of the CDC’s vaccine advisory board.
The layoffs will heavily affect Vertex’s operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmed’s Phase IIb readout “impressive across the board,” 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 pharma’s amylin efforts underwhelmed investors.
The deal is Lilly’s 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 CDC’s Advisory Committee on Immunization Practices; Metsera’s 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.