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AstraZeneca Hopes To Save FluMist In US With Foreign Data

 
• By Derrick Gingery

After a CDC advisory committee recommends against the nasal flu vaccine's use in any setting, sponsor AstraZeneca looks to reconcile its effectiveness results with government findings.

AstraZeneca PLC finds itself in a battle to defend the effectiveness of its FluMist nasal influenza vaccine formulation in the US, its largest market for the product, after the Centers for Disease Control and Prevention recommended against its use.

CDC's Advisory Committee on Immunization Practices gave an interim recommendation June 22 stating that because FluMist, a quadrivalent live attenuated...

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BIO Notebook: Policy Problems, ACIP’s Future, BI Is Popular, Makary On FDA-Industry Ties

 
• By Sarah Karlin-Smith and Mandy Jackson

Highlights from Day Two of the BIO International Convention include BIO officials raising concerns about Trump Administration policies, the future of ACIP, an interview with BI's head of global business development, and FDA Commissioner Martin Makary's view of the FDA-industry relationship.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

More from North America

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

 
• By Dean Rudge

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.