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An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) have not halted their investigation into the pricing of Emflaza, pursuing its sale from Marathon to PTC Therapeutics. Read More
The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing Wednesday. Read More
Sanofi and Regeneron filed a complaint seeking a declaratory judgment that their eczema drug Dupixent, which is pending an FDA approval, does not infringe an Amgen patent on an unsuccessful asthma candidate. Read More
The Government and Accountability Office has agreed to grant a Senate request to conduct an investigation into the FDA’s handling of orphan drugs approvals. Read More
The FDA will have to staff up and hire new kinds of scientists to fully implement the provisions of the 21st Century Cures Act and the next generation of user fee agreements, according to FDA leadership. Read More