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Moderna’s Stronger Vaccine AdComm Vote Indicative Of Second Mover Advantage, Not Data Profile

 
• By Sarah Karlin-Smith

Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s phrasing of voting question complicated meeting but resulted in minimal harm.

Biotechnology company Moderna protocol files for COVID-19 vaccinations are kept at the Research Centers of America in Hollywood, Florida, on August 13, 2020. (Photo by Chandan Khanna/ AFP) (Photo by CHANDAN KHANNA/AFP via Getty Images)
Moderna was able to take notes on what worked and what didn't at Pfizer's advisory committee the week before. • Source: Chandan Khanna/AFP via Getty Images

Moderna’s COVID-19 vaccine got a more solid ‘yes’ vote than Pfizer/BioNTech’s, but committee chair cautions against drawing any comparisons between the products from the different tallies. Last-minute bickering over FDA’s phrasing of voting question complicated meeting but resulted in minimal harm.

Moderna, Inc.’s COVID-19 vaccine got a more resoundingly positive vote from an FDA advisory panel than Pfizer Inc. and BioNTech SE’s candidate achieved the week before, but...

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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

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

 
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More from Regulatory Trackers

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.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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.