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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 U.S. Supreme Court has agreed to the Biden administration’s request to review lower-court rulings that would curtail access to the abortion pill mifepristone, with a decision expected in the summer.
After a “reasonably strong year” in 2023, next year will see “similar levels” of M&A activity with increased investor interest in weight loss and cardiovascular diseases, contends professional services firm PwC.
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The agency is investigating reports of secondary blood cancers in patients who have received certain CAR T cell therapies, but experts say the risk is low and is outweighed by the terminal nature of some cancers.