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Novo Nordisk made some headlines in London this week, presenting positive data from hemophilia therapeutics trials at the International Society of Thrombosis and Hemostasis Annual Congress. Read More
Skyhawk Therapeutics, a three-year-old biotech spawned by entrepreneur, inventor and documentary filmmaker Bill Haney, has inked a new deal with Sanofi that has the two companies working together on challenging oncology and immunology targets. Read More
Faced with a barrage of pleas from both clinicians and patients, the FDA will hold a second expert panel hearing on Amylyx’s AMX0035, a drug intended to treat amyotrophic lateral sclerosis (ALS). Read More
Uveitis — an inflammation of the middle layer of the eye — in treated patients has prompted FDA to halt enrollment in Nuvation Bio’s phase 1/2 dose-escalation study of NUV-422, a checkpoint inhibitor under investigation for a wide variety of solid tumors. Read More
Study investigators said it is “expected there will be limited [Aduhelm] prescription and usage in routine clinical practice making the study not feasible for enrollment.” Read More
Sarepta Therapeutics has been hit with an FDA clinical hold on its trial of SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy after a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Read More