Verdiperstat, Biohaven’s investigational drug for amyotrophic lateral sclerosis (ALS), didn’t pass its phase 3 muster, failing to slow progression of the fatal muscle-wasting disease. Source: Drug Industry Daily
One day before the end of the fiscal year, the U.S. Senate passed a continuing resolution (CR) with FDA user fee authorization attached to it, moving closer to an 11th-hour…
Multiple comments on the FDA’s efforts to provide guidance on how sponsors can develop patient-focused clinical outcome assessments (COA) for regulatory decision-making called for more clarity on one of the…
Biogen and developmental partner Esai are touting positive phase 3 data for their antiamyloid antibody lecanemab, saying the drug slowed cognitive decline by 27 percent among 1,795 patients with early…
The FDA issued a warning letter to Zhejiang Tianyu Pharmaceutical for significant deviations from current good manufacturing practices (cGMP), including impurities and lax cleaning of equipment. Source: Drug Industry Daily
The Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies has been renamed the Office of Therapeutic Products (OTP). Source: Drug Industry Daily
Following up on a provision of the CARES (Coronavirus Aid, Relief and Economic Security) Act on the regulation of over-the-counter (OTC) monograph drugs, the FDA has issued draft guidance on…
The FDA has placed a partial clinical hold on Avidity Biosciences’ phase 1/2 MARINA study after one person treated with AOC 1001, an investigational gene therapy for myotonic dystrophy type…
Biogen has agreed to pay $900 million to resolve a federal whistleblower lawsuit charging that the company bribed doctors with kickbacks to prescribe its multiple sclerosis drugs, resulting in the…
The version of user fee legislation that’s slated to be attached to a continuing resolution (CR) later this week — just days before the end of the fiscal year —…