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Janssen’s COVID-19 Vaccine Should Continue To Be Available, CDC Panel Concurs

 
• By Brenda Sandburg

Benefits of the one-shot vaccine outweigh risk, ACIP members agree. One member says he supports its availability but would personally recommend mRNA vaccines instead.

Janssen COVID-19 vaccine
CDC advisory committee supports continued use of Janssen's COVID-19 vaccine • Source: Alamy

The low incidence of the neurological disorder Guillan-Barré syndrome in those receiving Johnson & Johnson’s COVID-19 vaccine is outweighed by the vaccine’s benefits in protecting against SARS-CoV-2 infection, hospitalization and death, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) concluded.

At a 22 July meeting, ACIP members were asked to discuss whether the one-shot vaccine, sold by J&J’s Janssen unit, should continue to be used according to current recommendations

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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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