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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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Biomarkers as a surrogate endpoint in ALS will go on trial on March 22 as Biogen and Ionis’s tofersen faces the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee.
Sangamo Therapeutics lost two powerhouse partners Friday after it reported that both Novartis and Biogen discontinued focusing on gene regulation therapies in the neurology space.
On Feb. 28, Novavax issued a candid warning to investors: it may not be able to continue operations beyond February 2024. BioSpace takes a deep dive into the vaccine maker’s prospects.
For Daiichi Sankyo, recent results from the Phase III CLEAR trial of Esperion Therapeutics’ Nexletol (bempedoic acid) were not convincing enough to trigger a milestone payment.
An advisory committee will meet March 22 to discuss the fate of Biogen and Ionis’ ALS hopeful tofersen. For that and more, see inside.
Pfizer and Astellas announced positive topline Phase III results Thursday for Xtandi plus leuprolide in non-metastatic castration-sensitive prostate cancer.
Amgen is terminating 450 workers in hopes of weathering dropping drug prices and rising inflation. This is Amgen’s second round of job cuts this year.
The FDA will hold an advisory committee meeting for Sarepta’s investigational gene therapy for Duchenne muscular dystrophy ahead of its May 29, 2023 action date.
Real estate development firm Sterling Bay launches life sciences division starting with Lincoln Yards, a 320,000 square foot site on the Chicago River.
The new financing will help the Boston-based biotech accelerate the development of its siRNA-based therapies for immuno-dermatology indications.