Amgen and AstraZeneca announced that their Phase III NAVIGATOR trial of the potential first-in-class human monoclonal antibody tezepelumab hit the primary endpoint in severe asthma.
U.S. regulators authorized emergency use of the first experimental antibody drug for Covid-19 in patients who are not hospitalized but are at risk of serious illness because of their age or other conditions.
Shares of Calliditas Therapeutics soared in trading after the company announced positive Phase III data from a study of Nefecon in IgA nephropatjhy (IgAN), an autoimmune renal disease.
Biogen Inc.’s shares slumped as the drugmaker’s chances of getting a regulatory approval for the experimental Alzheimer’s treatment aducanumab suffered a blow after a panel of experts to the U.S. Food and Drug Administration voted against the medicine.
A panel of outside advisers to the U.S. Food and Drug Administration voted that a potential Alzheimer’s treatment from Biogen Inc. has not been proven to slow progression of the disease, a sharp rebuke to agency staff who had praised the drug.
A panel of outside advisers to the U.S. Food and Drug Administration voted that one of two large studies on Biogen Inc.’s experimental Alzheimer’s disease drug cannot be viewed alone without regard for the other failed trial.
Shares of Endo International were up after announcing positive earnings and a new restructuring plan that is expected to “optimize” the company’s operations through the elimination of several manufacturing sites and the employees who work there.
Merck & Co. Inc. agreed to acquire privately held VelosBio Inc. for $2.75 billion in cash, in a move that will help strengthen the company’s cancer drug portfolio.
Biogen Inc. showed “exceptionally persuasive” evidence that the company’s experimental Alzheimer’s disease drug aducanumab is effective, U.S. Food and Drug Administration staff said, elevating chances of a swift approval and sending company shares soaring.
Missouri’s highest court refused to consider Johnson & Johnson’s appeal of a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in its baby powder and other talc products.