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Latest From Ipsen SA
Addressing The Rare Disease Challenge Via Patient Engagement
Following the FDA’s release of draft guidance to enhance patient voice, In Vivo spoke with Ipsen’s rare disease regulation expert on creating a more patient-centric R&D and approval pathway, from modified endpoints to trial decentralization and beyond.
EU Marketing Setback For Ipsen’s Connective Tissue Disease Drug
The European Medicines Agency is standing by its recommendation to reject Ipsen’s EU marketing authorization application for Sohonos, for treating fibrodysplasia ossificans progressiva.
Big Pharma Companies Have Higher US FDA Approval Percentage Than Everybody Else
Almost 80% of novel agent submissions from the biggest companies were approved in recent years, compared with a 60% approval rate for the rest of the industry, according to a Pink Sheet analysis of FDA approval decisions since 2021.
Digital Health Roundup: HIMSS, Cardio Conversations, ChatGPT And New FDA Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm, and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.
- OTC, Consumer
- Specialty Pharmaceuticals
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- Albireo Pharma, Inc.
- Clementia Pharmaceuticals, Inc.
- Epizyme, Inc.
- Ipsen Bioscience, Inc.
- Tercica, Inc.
- Syntaxin Ltd.
- OctreoPharm Sciences GmbH
- Octagen Corporation
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