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The trials, which were testing the tyrosine kinase inhibitor masitinib, had previously been paused. AB Science’s decision not to resume them was a matter of prioritization, not safety, the biotech said.
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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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Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a biotech consolidation company owned by the venture capital firm he runs.
Takeda’s layoffs include cutting 247 people in Massachusetts. The workforce reduction is meant to help offset investments in areas including a product launch for oral drug candidate zasocitinib, for which the pharma today announced positive Phase 3 data.
While tonlamarsen missed one of two co-primary endpoints, Kardigan says the drug has shown a clinically meaningful effect on blood pressure, supporting advancement into Phase 2b.
The FDA rejected the high-dose regimen of Spinraza in September last year due to manufacturing concerns.
William Blair hailed a positive readout in cutaneous lupus erythematosus as a turning point for Biogen, while RBC Capital analysts called the results “another derisking step” for the company’s immunology and inflammation pipeline.
The lack of a dose-response effect could be due to the high number of dropouts in the higher-dose Winrevair arm and the relatively small study population, a discussant for Merck explained.
The Insilico Medicine agreement plays into Eli Lilly’s recent AI push, anchored by a partnership last year with NVIDIA to build a supercomputer to optimize drug discovery and shorten the development timeline.
AbbVie’s Skyrizi appears to have stronger efficacy than Johnson & Johnson’s newly approved pill Icotyde, as well as a less frequent dosing schedule that patients could prefer, according to analysts at BMO Capital Markets.
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Accumulating scientific evidence and industry interest from Eli Lilly, Altimmune and startup Baseline Therapeutics is driving further research on the therapeutic potential of GLP-1 receptor agonists in treating substance use disorders.