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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
PhRMA urged the HHS inspector general to create a new safe harbor in anti-kickback regulations to directly address value-based payments and rebates. Read More