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Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee

 
• By Sarah Karlin-Smith

US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.

FDA Advisory Committee Feature image
Charleston was unsuccessful at its second advisory committee for Hydexor

US Food and Drug Administration advisors’ general lack of confidence in risk evaluation and mitigation strategies ability to lessen safety concerns with drugs appeared to be a significant factor in the negative panel vote on 2 November against Charleston Laboratories, Inc.’s opioid combo Hydexor.

The Anesthetics and Analgesic Drugs Products Advisory Committee and Drug Safety and Risk Management Advisory Committee members who voted against Hydexor, which is designed to reduce emesis, also had particular criticism for the sponsor’s REMS, saying it

Hydexor is a fixed-dose combination of hydrocodone and acetaminophen along with promethazine, which was added to reduce or prevent the

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
• By Bridget Silverman

The 31 May goal date for Moderna’s next-generation COVID-19 vaccine looms over the month, but the US FDA's decision lineup includes three more novel agents, including AbbVie's Teliso-V antibody-drug conjugate, as well as supplemental indications like GSK's bid for Nucala in COPD.

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

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