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Novo Nordisk has settled a patent dispute with Novartis over allegations that the Swiss company infringed on patents for Victoza (liraglutide), Novo Nordisk’s blockbuster type 2 diabetes drug. Read More
Takeda Pharmaceuticals has received a Complete Response Letter from the FDA denying its Prior Approval Supplement (PAS) application for Natpara (parathyroid hormone) for chronic hypoparathyroidism. Read More
After 14 years of legal wrangling over Fosamax’s bone-fracture risk, Merck has managed to get a federal judge to dismiss in excess of 500 lawsuits charging the drugmaker with staying silent about the dangerous and painful leg breaks the osteoporosis drug was allegedly known to cause. Read More
Just hours before it was to face the start of a trial, Sun Pharmaceuticals of India said it will pay $485 million to settle years-old lawsuits alleging its Ranbaxy Pharmaceuticals subsidiary falsified data to hoodwink the FDA into granting exclusive approvals for its generic drugs, thus delaying competition and making people pay exorbitant prices for the generics. Read More
A coalition of advocacy groups has appealed to Health and Human Services Secretary Xavier Becerra to act unilaterally to lower the prices of six prescription drugs using an obscure and controversial regulatory authority known as “march-in rights.” Read More
The FDA has issued a warning letter to Monroe Township, N.J.-based Premier Trends for online marketing of a misbranded and adulterated drug called Magic Heal, an over-the-counter blend of essential oils used to promote skin health. Read More
Because its phase 3 trial was conducted only in China, the FDA has told Eli Lilly to go back to the drawing board with its promising investigational checkpoint inhibitor sintilimab for the treatment of nonsmall-cell lung cancer (NSCLC). Read More
ECI Pharmaceuticals said a warning letter it received from the FDA for listing an incorrect active pharmaceutical ingredient for its drug products was the result of a “clerical error.” Read More
India currently makes the lion’s share of active pharmaceutical ingredients (APIs), the raw materials used to create prescription drugs, for the U.S. Read More
The settlement “will further support public health efforts to respond to the challenges brought on by this epidemic,” said Rhode Island Attorney General Peter F. Neronha. Read More