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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.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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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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Basilea Pharmaceutica received FDA approval for its antibiotic Zevtera in three indications Wednesday, finally getting the drug across the finish line a decade and a half after the agency rejected an earlier submission.
Amid a flurry of deals in the antibody-drug conjugate space, Merck KGaA is getting in on the action with a partnership with Caris Life Sciences to accelerate the discovery and development of first-in-class ADCs for oncology.
Following disappointing late-stage data, Amylyx on Thursday said it is withdrawing the company’s amyotrophic lateral sclerosis drug Relyvrio from the U.S. and Canadian markets and cutting its workforce by approximately 70%.
Three Biopharma firms disclosed concerns about how emerging geopolitical tensions between the U.S. and China might impact their business with the contract manufacturer.
A Delaware judge on Wednesday agreed with Roivant subsidiary Arbutus and Genevant’s interpretation of specific patent claims regarding the lipid nanoparticle delivery system used by Moderna’s COVID-19 vaccine.
Sanofi has in principle reached a settlement related to its discontinued heartburn drug Zantac, though the French pharma did not disclose the financial terms of the deal.
Congress and the Biden administration have set their sights on lowering prescription drug costs.
Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.
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