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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
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
The growing burden of rebates and discounts has left drugmakers “underwater” on manufacturing inexpensive, generic cancer drugs, and has significantly harmed the supply chain for these treatments, the Community Oncology Alliance (COA) said in a recent statement. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Following recent tornado damage to its Rocky Mount, N.C., manufacturing facility, Pfizer announced emergency ordering procedures to manage inventory for 12 formulations of nine drugs. Read More
Only 28 out of 64 medical device and diagnostic technologies, or 44 percent, requiring new Medicare coverage received reimbursement from 2016 to 2019, with the median time to at least nominal coverage taking 5.7 years, according to Stanford University researchers. Read More