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Advicor, Simcor Withdrawals Show There's A Lot Riding On CV Outcomes Studies

 
• By Sue Sutter

Surrogate markers for cardiovascular products may be going the way of AbbVie's cholesterol franchise.

FDA's formal withdrawal of two AbbVie Inc. hyperlipidemia drugs for failure to demonstrate cardiovascular benefit is yet another reminder of the regulatory and commercial importance – and ramifications of potential failure – of ongoing CV outcomes studies for the PCSK9 inhibitors and Amarin Corp. PLC's Vascepa.

In an April 18 Federal Register notice, FDA withdrew approval of the NDAs for Advicor (niacin extended-release/lovastatin) and...

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More from United States

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.

Medicare Part D LIS Access Threatened By House Budget Bill’s Medicaid Obstacles

 
• By Cathy Kelly

An unintended consequence of a provision framed as an administrative change in the bill could significantly reduce medication adherence among low-income older adults and increase mortality, a study found.

Trial Cancellations And Delays Persist For CROs Amid Biotech Slowdown

 
• By Vibha Sharma

The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.

Anti-Vaccine Activists Among New US CDC Vaccine Advisors

 
• By Sarah Karlin-Smith

HHS Secretary Kennedy's new ACIP appointments include multiple members of anti-vaccine groups and people who have spread misinformation about COVID-19 vaccines.

More from North America

US FDA May Consolidate Support Services After Extensive Cuts

 
• By Derrick Gingery and Sue Sutter

Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By Sue Sutter

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.