Alnylam Pharmaceuticals announced that a year-long phase 3 trial of its drug patisiran showed that the therapy met both its major objectives in patients with transthyretin-mediated amyloidosis (ATTR) with cardiomyopathy,…
Generics makers will soon have the option to submit expedited safety reports electronically to the FDA Adverse Event Reporting System (FAERS), according to a new draft guidance that provides instructions…
Johnson & Johnson (J&J) disclosed that it has pursued arbitration against beleaguered vaccine manufacturer Emergent BioSolutions for alleged breach of contract. Source: Drug Industry Daily
More than 100 West Virginia cities and counties have reached a $400 million settlement with drug distributors McKesson, AmerisourceBergen and Cardinal Health, resolving allegations that the companies recklessly oversupplied West…
Gilead Sciences’ Biktarvy, a three-component antiviral, suppressed HIV infections in 99 percent of patients who took it as part of two phase 3 studies. There were no treatment failures, the…
Sanofi has failed to convince a federal appeals court that Viatris monopolized the market for injected epinephrine through anticompetitive pricing for its EpiPen. Source: Drug Industry Daily
Swiss biotech ObsEva has announced a corporate restructuring and layoffs following a notice from the FDA that the company’s new drug application (NDA) for its lead candidate linzagolix for uterine…
After less than stellar interim results from a phase 3 trial focused on head and neck cancer, AstraZeneca is calling it quits in the indication for the checkpoint inhibitor it…
Recognizing that a lack of standard methods is the primary challenge to widespread manufacturing of cell and gene therapies, two groups are aiming to lower the barrier by bringing best…
Massachusetts-based Editas Medicine announced that the FDA has removed a partial clinical hold on its trial of EDIT-301 (AsCas12a), its experimental gene treatment for severe sickle cell disease. Source: Drug…