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The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
Mylan reached a settlement with Roche and Genentech that paves the way for the generic drugmaker to market a biosimilar version of the blockbuster drug Herceptin. Read More
The USPTO's Patent Trial and Appeal Board validated four of Acorda’s patents on the multiple sclerosis drug Ampyra, but a federal court still has to determine whether five of the drug’s patents are valid before generic drugmakers can market versions of Ampyra. Read More
Amgen is calling on the U.S. Supreme Court to rule that biosimilar makers must wait six months after an FDA approval to market their therapy. Read More
Two FDA advisory committees voted Tuesday that the benefits of a previously approved formulation of Opana ER no longer outweigh the risks of abuse. Read More
Australia’s TGA increased first-time inspections of drug manufacturing facilities by 16 percent in the second half of 2016 compared to the same period a year earlier, according to the agency’s latest performance report. Read More