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FDA Conflict Of Interest Waiver On Victoza Is Textbook Example For Supporters, Foes

 
• By Michael Cipriano

Novo Nordisk's Victoza will get US advisory committee review June 20, and Tufts Medical Center's Marvin Konstam will serve on panel even though his institution participates in a trial for Janssen's Invokana.

A man stand opposite two arrows pointing down.Black and white

The US FDA's most recent issuance of a conflict of interest waiver to a temporary voting advisory committee is showing to be a textbook example of how the agency administers its policy on the subject.

FDA posted June 5 a granted conflict of interest waiver for Marvin Konstam, chief physician executive at the...

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US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

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More from Regulatory Trackers

EU Authorization Before US? Biologics Manufacturing Is Likely To Blame

 
• By Bridget Silverman

In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.

Global Pharma Guidance Tracker - April 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
• By Bridget Silverman

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