Sarah Karlin-Smith
Senior Writer at The Pink Sheet
Covering intersection of pharma, policy & politics for @pharmapinksheet. Past @smpagwu adjunct, @politico. Signal: SarahKarlinSmith.34
Articles
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11 hours ago |
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA Vaccine Framework Coming In Weeks, But Details VagueNew CBER Director Prasad will "unleash a massive" framework on vaccines, FDA Commissioner Marty Makary said 15 May, raising questions about the impact on products nearing approval. Martin Makary spoke 15 May at the Food and Drug Law Institute's annual conference. (Sue Sutter)
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2 days ago |
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and Keytruda’s expectations for their cancer drugs. The guidance also tackles Part B and renegotiated prices for the first time. Medicare is considering changing how it addresses certain combination products for price negotiation purposes, which could impact new subcutaneous cancer drug formulations. (Shutterstock)
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3 days ago |
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
House Budget Bill Includes Delayed Orphan Fix, Also Risks Downstream Cell and Gene Coverage The first two classes of negotiated drugs under the Inflation Reduction Act would not benefit from a rare disease adjustment House Republicans included in their reconciliation package. A long sought change to the Medicare drug price negotiation program benefiting orphan drug developers appears more likely to move through Congress this year. (Shutterstock)
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1 week ago |
feeds.feedblitz.com | Sarah Karlin-Smith
Key TakeawaysThe European Medicines Agency’s safety committee, the PRAC, has started a review of Valneva’s chikungunya vaccine, Ixchiq, following reports of serious adverse events in elderly people. The PRAC will review all available data to assess the benefits and risks of the vaccine and make a recommendation on whether to change the terms of its marketing authorization.
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1 week ago |
feeds.feedblitz.com | Sarah Karlin-Smith
Large Indian drug makers have generally welcomed the US Food and Drug Administration’s plan to expand the use of its foreign unannounced inspections pilot program, though some industry experts say that much of the impact will depend on “enforcement consistency,” local co-operation and the ability of manufacturers to adapt.
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