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In an unusual case, Novo Nordisk agreed this week to pay $89,315 to Danish authorities to settle allegations it didn’t disclose the FDA’s rejection of two insulin products fast enough. Read More
Eli Lilly and Boehringer Ingelheim have won tentative FDA approval for their insulin product Basaglar, which is considered the biosimilar of a Sanofi product in Europe but is being reviewed as its own NDA in the United States. Read More
The FDA has approved Biogen Idec’s new multiple sclerosis treatment Plegridy, creating another opportunity for the drugmaker in the crowded MS market. Read More
The UK’s health cost-benefit watchdog put Gilead Sciences’ Sovaldi a step closer to winning National Health Service coverage, recommending the drug for the treatment of three types of hepatitis C infection. Read More
The FDA is asking Acura Pharmaceuticals to conduct an additional study to prove its abuse-deterrent painkiller can actually deter abuse, throwing a wrench into the small drugmaker’s plans for approval. Read More
Roche got the greenlight on Thursday to market its blockbuster cancer drug Avastin for the treatment of advanced cervical cancer, making it the first biologic drug approved in combination with chemotherapy for the disease. Read More
Impax received its second Form 483 in less than a week for a poor inspection of its U.S. manufacturing facility, igniting fresh doubts on the company’s plan to win approval of its Parkinson’s drug Rytary. Read More