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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. Read More
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 four types of COA — patient reported outcomes (PRO) — and on using digital health technology (DHT) for COA data. Read More
The Center for Biologics Evaluation and Research’s (CBER) Office of Tissues and Advanced Therapies has been renamed the Office of Therapeutic Products (OTP). Read More
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 Alzheimer’s disease. Read More
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Aid, Relief and Economic Security) Act on the regulation of over-the-counter (OTC) monograph drugs, the FDA has issued draft guidance on how submitters should send OTC monographs requests (OMOR) electronically prior to marketing a drug. Read More
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 1 (DM1), experienced a serious adverse event. Read More
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 submission of false claims to Medicare and Medicaid. Read More
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 — is devoid of any riders House of Representatives members and Senators worked to attach to it over the summer. Read More