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Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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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 European Medicines Agency has widened its review of potential suicide risks associated with GLP-1 receptor agonists. The probe, which started July 3, is expected to conclude in November.
The biotech has acquired an exclusive global license for Shanghai-based DualityBio’s investigational antibody-drug conjugate for select solid tumors.
The biotech Monday announced a clinical hold on its HEMO-CAR-T candidate, which is being trialed for the treatment of acute myeloid leukemia, due to manufacturing concerns cited by the regulator.
After its Biologics License Application was rejected by the FDA, BrainStorm’s Phase III data suggest its amyotrophic lateral sclerosis candidate significantly lowers neurofilament light chain levels.
Johnson & Johnson has licensed Nanobiotix’s lead radioenhancer candidate, designed to increase the efficacy of radiation treatment in cancers, capitalizing on the latter’s rocky financial situation.
The biotech will supply Canada with fewer doses of its coronavirus vaccine while reaching a financial agreement for the forfeiting of certain doses previously scheduled for delivery.
After an initial series of legal complaints in June, Novo Nordisk filed four new lawsuits Thursday against Florida and Tennessee pharmacies for allegedly selling products containing semaglutide.
Gene editing technologies are advancing rapidly in the clinic, with the potential first approval later this year, but challenges remain.
Phase III trial data published Thursday show significant survival benefit as a first-line treatment in advanced non-small cell lung cancer patients not fit for standard platinum-based doublet chemotherapy.
Following the FDA’s full approval of the Alzheimer’s drug Thursday, the Centers for Medicare and Medicaid Services confirmed broader coverage of Leqembi and released more details on a registry.