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While the FDA and industry are gung-ho about the commitments they fine-tuned for the second rendition of the biosimilar user fee agreement (BsUFA), patient advocacy groups and health care providers aren't so happy with some of the measures.

Hung up in the U.S. and overseas, PTC Therapeutics Inc.'s appeal to the FDA regarding the effort with Translarna for nonsense mutation DMD "does not have much of a leg to stand on" in the view of RBC Capital Markets analyst Simos Simeonidis.

Congressional frustration over unjustified price hikes for U.S. drugs is reaching a boiling point that could erupt into far more government oversight that would spill over to medical devices.

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