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Pharmaceutical intellectual property rights remain a significant sticking point in a proposed draft of the massive Trans-Pacific Partnership (TPP) trade pact leaked last month. 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
Generic drug prices in Canada are up to seven times more expensive than those in comparable countries, according to a study that challenges a major price-setting deal between Canadian generics firms and provincial governments. 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
A federal judge has struck down Mylan’s Paragraph IV ANDA challenge against Pfizer’s blockbuster cancer drug Sutent, ruling that the therapy’s patents are not invalid. 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
Dr. Reddy’s Laboratories has settled a class-action lawsuit over its alleged role in delaying generic entry of AstraZeneca’s heartburn drug Nexium in return for assisting plaintiffs in their case against AZ and the remaining generics manufacturer defendants. Read More
Actavis’s birth control pill Lo Loestrin FE is safe from generic competition for the moment after a federal appeals court reaffirmed a lower court’s decision finding that ANDAs by generics makers Lupin and Amneal infringed the drug’s patent. 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
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