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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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Shares of Spectrum Pharmaceuticals plunged 33% upon the release of briefing documents for an FDA advisory meeting regarding poziotinib
Beyond the usual challenge of delivering high-quality data that answers meaningful questions, PepGen’s Michelle Mellion is dedicated to “incorporating the patient’s voice into everything we do.”
Pres. Joe Biden declared the COVID-19 pandemic over. Biopharma stocks react as vaccines and antivirals are still in development.
Alzheon Inc. unveiled promising data from a Phase II biomarker trial of its investigational drug ALZ-801 to treat early Alzheimer’s disease.
Shares of Renovacor, Inc. stock are surging in premarket trading following Rocket Pharmaceuticals’ announcement it will acquire the company in an all-stock transaction valued at $53 million.
Wave Life Sciences presented promising early data from its Phase Ib/IIa SELECT-HD trial in Huntington’s disease with evidence of biomarker improvements.
First Wave BioPharma announced that it is restarting its adrulipase program for the treatment of exocrine pancreatic insufficiency in cystic fibrosis and chronic pancreatitis.
Six months after its launch, Vesalius Therapeutics is laying off 43% of its staff. With a current staff of 67, the company is slashing 29 jobs.
Genfit announced that it is Versantis for roughly $40 million cash and approximately $65 million in milestone payments and other considerations.
The past week saw promising developments in candidate therapies for cancer, congenital hyperinsulinism, chronic cough and COVID-19 vaccines.