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The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially lethal contaminant since March — and nine on the issue just this week. Read More
Texas has settled with Takeda Pharmaceuticals and Baxter International for $42 million over allegations the companies provided kickbacks to Medicaid providers to recommend prescription medications including the attention deficit hyperactivity drug (ADHD) Vyvanse (lisdexamfetamine dimesylate). Read More
Formycon and Fresenius Kabi’s FYB202 will be among the first Stelara (ustekinumab) biosimilars to launch, after the makers reached a legal settlement with Johnson & Johnson, whose patent on the blockbuster drug is set to expire this fall. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment and medical device risk management tools. Read More
The big three drug associations, representing brand pharmaceuticals, generics and biotechnology, have all expressed strong objections to the CMS proposed rule for the Medicaid Drug Rebate program “stacking” requirement that revises the definition of “best price.” Read More
Nektar Pharmaceuticals has launched a two-pronged attack on Eli Lilly: A legal filing charging that Lilly intentionally sabotaged its development of Rezpeg, an investigational biologic the companies were co-developing for systemic lupus erythematosus (SLE) and dermatologic conditions, and a public relations campaign designed to alert the public to the allegedly shady dealings. Read More
Gingko Bioworks announced a new $490 million collaboration with Merck to improve Merck’s biologics production efficiency and increase yields. Read More
Vistagen’s fasedienol (PH94B) nasal spray for social anxiety disorder (SAD) showed a statistically significant reduction in anxiety measures during a public speaking challenge, using a measure of subjective units of stress score. Read More
Enrolling 17,604 overweight adults aged 45 and over with established cardiovascular disease, Novo Nordisk’s five-year trial of Wegovy (semaglutide) for weight loss showed a 20 percent reduction in major adverse cardiovascular events (MACE). Read More