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1 week ago | 
insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs
Pink Sheet Podcast: US FDA’s Private Pharma CEO Tour, HHS Changes COVID-19 Vaccine AdvicePink Sheet reporter and editors consider the issues that could emerge during upcoming private FDA forums with pharma CEOs, as well as the impact of the surprising move by HHS Secretary Robert F. Kennedy Jr. to limit the CDC recommendation for annual COVID-19 vaccine boosters. What will pharma CEOs tell FDA leadership during the private CEO forums? • Source: Citeline/Shutterstock
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1 week ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’ The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints. CBER Director Vinay Prasad discussed accelerated approval and cancer with FDA Commissioner Martin Makary after a 20 May presentation. (US FDA webstream)
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1 week ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA Makary’s Pharma CEO Tour Goes Against Transparency Rhetoric FDA Commissioner Martin Makary will give industry a new avenue for access and influence despite his and HHS Secretary Robert F. Kennedy Jr.’s claims that the pharma-FDA relationship is too cozy. Some drug companies with applications at the FDA may be able to meet with top agency leadership as part of upcoming "CEO Forums." (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Derrick Gingery |Sarah Karlin-Smith |Sarah Karlin-Smith |Sue Sutter |M. Nielsen Hobbs
Pink Sheet Podcast: US FDA’s Big Vaccine Policy WeekPink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector. How will the new FDA COVID-19 vaccine development framework impact the Pfizer/BioNTech and Moderna products? • Source: Citeline/Shutterstock
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2 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA Punts On New COVID-19 Framework’s Impact On Fall ShotsThe FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on impact availability. At the 22 May VRBPAC meeting, the FDA declined to discuss how its new COVID-19 vaccine framework could impact strain changes for 2025-2026 shots. (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy The FDA may have violated laws and regulations along with many norms in how it released its planned changes for COVID-19 vaccine approvals. FDA Commissioner Martin Makary interviewed CBER Director Vinay Prasad about the new COVID-19 vaccine framework. (FDA webcast)
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2 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May. Novavax's belated COVID-19 vaccine approval comes with a label differentiating it from competitors. (Shutterstock)
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3 weeks ago | 
insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith
US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data. FDA Deputy Commissioner Grace Graham wants reform, not complete abandonment, of user fees. (Shutterstock)
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3 weeks 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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3 weeks 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)
