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Amgen’s open-label confirmatory study of its lung cancer drug Lumakras (sotorasib) had too many data integrity problems to effectively show that the drug is an improvement over the standard-of-care chemotherapy docetaxel, according to the Oncologic Drugs Advisory Committee (ODAC), which met Thursday. Read More
Over the past week, the FDA issued a proposed rule on laboratory developed tests, final guidance on labeling for dosing of human prescription drugs and biological products and draft guidance on stimulant drug use disorders. Read More
Fourteen days of FDA inspection of its New Brunswick, N.J., facility in February and March earned Spectrum Laboratory Products a 483 describing yellow streaks on floors, peeling paint on walls and only 58 of 5,679 complaints investigated, among the 14 observations in the FDA’s report. Read More
Thirty-one organizations from across life sciences came together to oppose the FTC’s new approach to antitrust enforcement and launched the Partnership for the U.S. Life Science Ecosystem (PULSE), a new coalition to raise awareness of the fundamental role of “pro-innovation M&A” in advancing the next generation of treatments and cures for patients. Read More
The issues the industry is grappling with these days dovetail perfectly with topics on tap at the GMP Quality Management Virtual Summit 2023 Oct. 11 and 12, according to Steve Lynn, this year’s new conference lead. Read More
US WorldMeds got a 14-6 thumbs-up from FDA’s Oncologic Drugs Advisory Committee, supporting DFMO (difluoromethylornithine) to reduce the risk of relapse in children in remission after multifaceted treatment for high-risk neuroblastoma. Read More
A study published in JAMA showed that glucagon-like peptide 1 (GLP-1) agonists medications used for weight loss — Ozempic and Wegovy (both semaglutide) and Mounjaro (liraglutide) — come with increased risks of gastrointestinal adverse events such as pancreatitis, bowel obstruction, and gastroparesis, the slowing or stopping of the movement of food from the stomach to the small intestine. Read More
On Monday the U.S. Patent and Trial and Appeal Board (PTAB) ruled that Novo Nordisk, maker of semaglutide, did not choose the “obvious” research road drug, thereby denying Mylan Pharmaceuticals its challenge on two of Novo’s existing patents. Read More
Sanofi and Teva Pharmaceuticals announced today a collaboration to co-develop TEV’574 to treat two types of irritable bowel disease (IBD) — ulcerative colitis and Crohn’s Disease. Read More
With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe cocaine use, methamphetamine use and prescription stimulant use disorder. Read More