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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
Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards. Read More
The FDA and the European Medicines Agency (EMA) have both issued guidances on various aspects of detecting, measuring, limiting and avoiding the presence of nitrosamine impurities in pharmaceuticals. Read More
An extended-release (ER) generic lamotrigine, used to treat epilepsy, is bioequivalent to GSK’s Lamictal, the FDA has determined — a finding that opens the way for pharmacy-level substitution of any generic ER lamotrigine product for the brand name. Read More
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry on its return to post-COVID normalcy. Read More