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Heplisav’s Hopes For U.S. Approval Could Rest On Narrower Population

 
• By Sue Sutter

In a “complete response” letter for the novel, adjuvanted hepatitis B vaccine, FDA cites the need for more safety data in the broad population of adults for which approval was sought; however, Dynavax says the agency appears open to considering a more restricted use, such as in patients with chronic kidney disease.

Dynavax Technologies Corp. is eyeing narrower populations – including chronic kidney disease patients and individuals ages 40 years and older – as a potential route to approval for its novel, adjuvanted hepatitis B vaccine Heplisav now that FDA has issued a “complete response” letter for broad use in adults.

On Feb. 25, one day after the vaccine’s user fee date, Dynavax announced that FDA had declined to approve Heplisav...

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More from United States

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• By Francesca Bruce

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• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

More from North America

Generic Drug Office’s Policy Staff Returning To US FDA

 
• By Derrick Gingery

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.