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  • ReconRecon

    Recon: Novartis Wins FDA Approval for Eye Drug; New ICER Report on Net Drug Price Hikes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis gets FDA boost in crowded eye drug market ( Reuters ) ( PMLive ) ( Press ) ICER Identifies Costliest US Drug-Price Hikes That Are Not Supported by New Clinical Evidence ( ICER ) ( Reuters ) ( Stat -$) Continuing Appropriations Act Changes Treatment of Authorized Generics in Medicaid Rebate Average Manufacturer Price ( FDA Law Blog ) FDA leaders worry ...
  • Regulatory NewsRegulatory News

    Biopharma CEOs Explain Problems With Biosimilars to Congress

    Following their Senate Finance Committee hearing in February, all seven biopharmaceutical CEOs have now offered hundreds of pages of written responses to more specific questions. The lackluster biosimilar market in the US is addressed in nearly all their comments, with some executives explaining in detail as to why their biosimilars have yet to gain market share, while undertones of biosimilar fear-mongering linger in others’ comments. Merck CEO Kenneth Frazier expla...