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Rx Adherence Claims For Ribasphere RibaPak Sent Packing

 
• By Sarah Karlin-Smith

FDA tells Kadmon Pharmaceuticals that it can’t promote convenience advantages, however factual, as clinical benefits without adequate and well-controlled studies.

Pharmaceutical companies need to be cautious about using convenience advantages in promotional material, a recent Office of Prescription Drug Promotion warning letter indicates. Inferring that such characteristics, even if true on their own, may improve patient outcomes, requires substantial evidence or substantial clinical experience to support the claim, FDA said.

FDA told Kadmon Corp. LLC that the intro letter for its hepatitis C drug Ribasphere RibaPak (ribavirin)...

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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.

ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.

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