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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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SpringWorks, Eli Lilly, EMD Serono and Mirati released data ahead of the European Society of Medical Oncology (ESMO) 2022 Meeting in Paris.
Alnylam announced results Thursday from the APOLLO-B study of patisiran that showed improved functional capacity in (ATTR) amyloidosis patients with cardiomyopathy.
Photys Therapeutics launched Thursday with $75 million in financing and a focus on developing phosphorylation-inducing chimeric small molecule medicines to target underserved diseases.
SpringWorks announced the expansion of its partnership with GlaxoSmithKline to develop nirogacestat in combination with GSK’s Blenrep for relapsed or refractory multiple myeloma.
BioVie announced topline results from a Phase II biomarker study in Alzheimer’s disease showing patient improvements in cognition and reductions in neural inflammation.
Wednesday evening, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
Orbital Therapeutics, co-founded by John Maraganore, launched with the goal of harnessing the full potential of RNA-based therapeutics to tackle diseases in a new and more effective manner.
Thousands of FDA employees may lose their jobs if Congress doesn’t reappropriate funding currently in place by the end of the month.
Arcutis scoops up Ducentis and its lead asset DS-234, UC San Diego receives $150M earmarked for stem cell, regenerative medicine research and Arsenal and ILiAD reel in new funds.
Landing your first internship can be a major milestone in your career journey. Here’s what you can do to set yourself up for success and make the most of your life science internship.