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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
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. 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
Manufacturers of forthcoming biosimilars argue that their products should have the same international non-propriety name (INN) as the reference product, and do not need a unique qualifier to distinguish them from the brand version for the purposes of tracking. Read More
Two lawmakers want HHS Secretary Sylvia Burwell to address questions about efforts by the Obama administration to bring rising generic prices under control. Read More
Manufacturers seeking approval of biosimilars in Europe will be able to use comparator biologics authorized outside the EU to gain marketing clearance. Read More
A top FDA generic drug official said the agency is implementing various initiatives to improve the way it communicates with manufacturers, including through the revision of an internal document on staff interactions with industry. Read More
The FDA is seeking industry feedback on burdens related to its regulations of clinical investigations on the safety and effectiveness of unapproved new drugs and biologics. Read More
The FDA is seeking public input on its efforts to facilitate patient participation in the regulatory approval process and on ways to assess those patient engagement activities. Read More