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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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Autolus Therapeutics is calling the Phase II FELIX trial, assessing its next-generation CAR-T therapy obe-cel for leukemia, a win after an interim analysis revealed an overall remission rate of 70%.
A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
ImmunoGen entered into a clinical collaboration deal with Gilead Sciences Friday to evaluate the safety and efficacy of two drugs that, when used in concert, have the potential to treat AML.
At ASH 2022, established hematology leaders like AstraZeneca, Janssen and Merck will showcase new data, and new players like Vega Therapeutics will launch new programs.
AstraZeneca posted two mid-stage wins at the 2022 San Antonio Breast Cancer Symposium on Thursday, touting the efficacy of capivasertib and camizestrant against breast cancer.
Compass’ twin clinical updates regarding its lead candidate spotlight the promise of psychedelic medicine.
Instil Bio is discontinuing the development of its unmodified tumor-infiltrating lymphocyte (TIL) therapeutic, ITIL-168, and laying off 60% of its staff.
Those who work in the biopharma industry often see more setbacks than successes. To understand how to overcome failures, BioSpace spoke with two experts on coping with setbacks and staying positive.
Sanofi has terminated its global development and commercialization pact with Revolution Medicines, Inc. for their SHP2 inhibitor drug candidate,
Novartis reported Thursday that a Phase III trial of iptacopan met its primary endpoint in paroxysmal nocturnal hemoglobinuria (PNH) - the company’s second win in this indication in as many months.