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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With no FDA drug approvals to date for stimulant use disorder, the FDA has published draft guidance outlining current recommendations for development programs and trial designs for treatment of moderate-to-severe cocaine use, methamphetamine use and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
Upcoming events in the coming weeks include four FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on what to expect from the FDA in 2024 and how to use UDI and UDI Data. Read More
Humira’s biosimilar competitors have overcome the approval and patent fight process, only to run straight into what may be an even bigger challenge: getting the drugs past pharmacy benefits manager (PBM) gatekeepers and earning the trust of clinicians and patients. Read More
Eli Lilly and Point Biopharma Global have announced that Lilly will pay $1.4 billion to acquire Point, a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer. Read More
The FDA has issued a revision to its Manual of Policies and Procedures (MAPP) describing how the Office of Generic Drugs will track and respond to ANDA suitability petitions, consistent with the commitments made in the GDUFA III commitment letter. Read More