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Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
An Indian pharma group contends the U.S. Trade Representative’s scrutiny of India’s intellectual property regime could dampen investment in the country. Read More
Amgen is suing Sandoz to stop the French drugmaker from marketing a biosimilar of its top-selling product Neupogen in the U.S., charging that Sandoz didn’t follow the rules for biosimilar development. Read More
Drugmakers are split on whether the FDA should establish a program to reserve proprietary product names, with some calling for a new fee-based system and others recommending ways to improve the current process that has derailed applications with late-stage name rejections. Read More
Generic drugmakers frequently miscalculate the amount of user fees they owe the FDA, a situation that has landed many companies on the GDUFA arrears list, the head of the FDA's user fee management division said. Read More
A federal judge slashed the $9 billion jury verdict levied against Takeda and Eli Lilly to $36.8 million in a case that alleged the companies misled patients about cancer risks of the diabetes drug Actos. Read More