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The rising obesity rate in the U.S. could foil Perrigo’s bid to offer the U.S.’s first OTC oral contraceptive, according to FDA briefing documents in advance of a two-day advisory committee meeting this week. Read More
Despite more than half of treated patients developing adverse reactions, Eli Lilly will seek a traditional full approval for donanemab after topline phase 3 data showed that the antiamyloid antibody prevented further cognitive decline in 47 percent of early-stage Alzheimer’s patients and slowed decline by up to 36 percent on two other scales. Read More
GSK has crossed the finish line with Arexvy (RSVPreF3-AS01E), the first respiratory syncytial virus (RSV) vaccine to win FDA approval for individuals age 60 years and older, but approval of Pfizer’s RSV candidate, Abrysvo (RSVpreF), may not be far behind. Read More
After heated delays involving a competitor and the FDA, Dublin-based Avadel Pharmaceuticals has won FDA approval for Lumryz, its extended-release formulation of sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy. Read More
Ascendis Pharma of Denmark got slapped with a Complete Response Letter (CRL) in which the FDA voiced concerns about the variability in the delivered dose of the company’s investigational treatment for adults with hypoparathyroidism. Read More
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. Read More
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. Read More