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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
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
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
Brandmaker Endo Pharmaceuticals and generics firm Impax Laboratories are facing their third lawsuit over allegations the companies cut an anticompetitive deal to delay generic competition on Endo’s pain medication Opana ER. Read More
A federal judge has dismissed to a local court a lawsuit alleging AstraZeneca negotiated illegal pay-for-delay settlements with generic firms to keep versions of its heartburn drug Nexium off the market. In his decision however, the judge also indicated that deals putting off generic competition can still qualify as “reverse payments” under antitrust statutes, even if no cash changed hands. Read More