Fierce Pharma May 24, 2024
Zoey Becker

In a change of pace from the recent COVID-related business struggles for Pfizer, the drugmaker has picked up a valuable reward from the FDA in the form of a priority review voucher (PRV).

The agency doled out the PRV after determining that Pfizer’s COVID-19 antiviral Paxlovid meets the bar for classification as a medical countermeasure to a material threat, according to a notice (PDF) in the Federal Register. Paxlovid won its full FDA approval about one year ago.

Such vouchers, an extra incentive for developing treatments against diseases with high unmet need, have proven to be quite lucrative. Companies can either use them to speed up high-stakes drug reviews at the FDA or sell them to other drug developers.

A...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma, Pharma / Biotech
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article