Archive for April 2023

The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with one abstention to recommend that the FDA restrict approval for the combination of AstraZeneca’s blockbuster cancer drug Lynparza (olaparib) and Zytiga (abiraterone) to just metastatic castration-resistant prostate cancer (mCRPC) patients whose tumors have a breast cancer gene (BRCA) mutation. Source: Drug Industry Daily

The FDA requires devicemakers to verify that a product meets each of its design specifications, which is generally accomplished through postproduction inspection or testing. Source: Drug Industry Daily

Takeda has another shot on goal for a self-administered subcutaneous form of its blockbuster Entyvio (vedolizumab) as maintenance treatment for patients with ulcerative colitis who have completed induction therapy with the antibody’s intravenous form. Source: Drug Industry Daily

The FDA has warned users of a vulnerability in Illumina’s genetic sequencing devices that could allow an authorized user to make changes to data from the devices. Source: Drug Industry Daily

Over the past week, the FDA issued an authorization of a medical device, a request for comments for a public workshop and proposed data and information collections. Source: Drug Industry Daily

The European Medicines Agency’s (EMA) human medicines committee has signed off on GSK’s Arexvy (recombinant, adjuvanted), the first respiratory syncytial virus (RSV) vaccine for adults age 60 years and older as well as six other new drugs at its latest monthly meeting. Source: Drug Industry Daily

Akorn Pharmaceuticals is recalling dozens of unexpired human and animal drug products in connection with a Chapter 7 bankruptcy filing, ending a five-year struggle to stay afloat through court battles and regulatory enforcement actions. Source: Drug Industry Daily

Starting in September, the European Medicines Agency (EMA) will begin gradually resuming its efforts to openly share clinical trial data for medical products, the agency reported. Source: Drug Industry Daily

Egypt’s Pharmaplast received an FDA warning letter on April 13 for failing to address drug component testing and equipment maintenance issues. Source: Drug Industry Daily

Elkhart-Ind.-based Voyant Beauty, a division of Accra-Pac, received an FDA warning letter on April 20 for not appropriately addressing benzene contamination of its over-the-counter topical aerosol products, found during an Aug. 23-Sept. 2, 2022 inspection. Source: Drug Industry Daily