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The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar. Read More
Drugmakers engaging in anticompetitive practices don’t get a free pass simply because federal regulators failed to act, the Federal Trade Commission has asserted in a pending court case. Read More
Allergan is taking its dispute with the state of New York over mandatory access to an older medication amid generic substitution all the way to the Supreme Court. Read More
A federal court has placed a temporary sales ban on Indian drugmaker Dr. Reddy’s Laboratories’ generic form of heartburn drug Nexium in the U.S. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner during a two-hour confirmation hearing Nov. 17. Read More
Biosimilars experts concluded that fostering the nascent industry would require many of the same elements that originally nurtured the generics industry: educational efforts, regulatory and patent changes, and most importantly, patience. Read More