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Sanofi's Lixisenatide Gets Clean Bill Of Health On CV Safety, Heart Failure

 
• By Sue Sutter

ELIXA trial results show neither increased nor decreased risk of major adverse cardiovascular events; Sanofi's diabetes drug, still unapproved in the U.S., becomes the only GLP-1 receptor agonist with CV outcomes data.

Neutral results from a large cardiovascular outcomes trial of Sanofi's diabetes drug Lyxumia (lixisenatide) bode well not only for the glucagon-like peptide-1 receptor agonist's chances of finally reaching the U.S. market, but also for maintaining clinical confidence in the safety of the GLP-1 class.

Results from the 6,000-patient ELIXA CV outcomes trial, released June 8 at the American Diabetes Association's scientific sessions in Boston, showed that lixisenatide neither increased nor decreased the risk of major adverse cardiovascular events (MACE)

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Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare?

 
• By Cathy Kelly

President Trump's ongoing interest in the policy, which would ensure the US government pays no more for prescription drugs than the lowest price available in comparable countries, continues to gain attention.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
• By Sue Sutter and Derrick Gingery

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

Pharma Industry Argues Tax, Other Incentives Better Than Tariffs

 
• By Jessica Merrill

Pharmaceutical industry organizations offered alternatives to tariffs that could maintain a secure domestic supply chain in public comments filed in response to a federal 232 investigation.

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