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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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Government backing, deep scientific talent and a robust pharma heritage are helping France punch above its weight, but turning research into investable companies remains a challenge.
For Peter Pitts, a former associate commissioner at the FDA, the appointment to the board of BrainStorm Cell Therapeutics is an opportunity to fulfill a promise he made long ago to a patient with ALS.
Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape.
Seventeen life sciences businesses awarded Massachusetts tax incentives to add and retain 426 combined jobs hit 10% of that target as of Dec. 31. Three companies, including Novartis, had reported layoffs either last year or this year.
Edgewise Therapeutics will now focus on a handful of cardiovascular programs including EDG-7500 for hypertrophic cardiomyopathy thanks to the non-dilutive capital from France’s Servier.
Swiss service provider CordenPharma is acquiring AmbioPharm, gaining facilities such as a plant in South Carolina to provide a fully U.S.-based supply.
“King Keytruda’s reign continues,” analysts at BMO Capital Markets declared after Chinese data for Summit Therapeutics’ ivonescimab were revealed at the American Society for Clinical Oncology in Chicago.
Riding a newfound surge of interest on infectious disease concerns, Moderna is linking up with a global vaccine foundation in hopes of developing a vaccine to slow the new surge in Ebola underway in the Congo and Uganda.
Expanding in the metabolic space, Eli Lilly has struck a back-loaded licensing deal with South Korea’s Hanmi Pharm for a mid-stage GLP-2 agonist being trialed for short bowel syndrome.
In addition to eliciting 17.3 months median overall survival vs. 8.5 months for patients given standard of care treatment in a prior study, Immuneering’s atebimetinib demonstrated a robust tolerability profile—something CEO Ben Zeskind said equates highly with survival.