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“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says

 
• By Sue Sutter

Office of New Drugs director says the agency is seeing more small, inexperienced companies traveling the drug development and approval pathway on their own. However, these firms need more advice from the agency and are all too eager to publicly share their one-sided view about these regulatory interactions.

The growing trend of “emerging sponsors” taking drugs through the development and approval process on their own is creating regulatory and public relations challenges for FDA, according to one of the agency’s senior drug review officials.

Speaking at the FDA/CMS Summit on Dec. 8, Office of New Drugs Director John Jenkins said small and often venture-backed...

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More from United States

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• 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

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More from North America

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.

US FTC Continues Effort To Eliminate Orange Book’s Improper Patent Listings

 
• By Urtė Fultinavičiūtė

In a somewhat surprising move, President Trump’s Federal Trade Commission is continuing a crusade to delist improper listings from the FDA’s Orange Book. Law firm Polsinelli’s chair Chad Landmon discussed the impact of the move on the generic drug industry.

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 
• By Sarah Karlin-Smith

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.