Sarah Karlin-Smith

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)

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New Guidance Suggests SubQ Keytruda, Opdivo Formulations May Not Avoid Medicare Negotiations New draft guidance on the third cycle of Medicare drug price negotiations goes against Merck and Keytruda’s expectations for their cancer drugs.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)

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)

1 week ago | insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBERIndustry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies. New CBER Director Vinay Prasad may end the regulatory flexibility era at the FDA. (Shutterstock)

1 week ago | insights.citeline.com | Sarah Karlin-Smith |Sarah Karlin-Smith

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.