Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Documents related to the COVID-19 vaccine developed by Pfizer and BioNTech that were in possession of the European Medicines Agency have been accessed by hackers.
Hope for Pneumococcal Pneumonia Patients as FDA Grants Priority Review of Pfizer’s Vaccine Candidate
Pfizer is one step closer to receiving approval for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate after the Food and Drug Administration (FDA) on Wednesday granted priority review of a Biologics License Application (BLA) for the invasive disease and pneumonia vaccine.
The consumer’s group Public Citizen demanded the Office of the Inspector General (OIG) for the U.S. Department of Health and Human (HHS) conduct an investigation.
Although vaccines will be available pending approval, there are questions as to how many people will quickly receive the vaccine and when more will be available.
President Donald Trump signed an Executive Order on Tuesday that ensures the U.S. government prioritizes delivery of COVID-19 vaccines to American citizens before sending it to other nations.
The document prepared and released by FDA staff indicates scientists from the agency plan to tell the advisory committee on Thursday that the available clinical trial data are adequate to support its safe and effective use in public immunization programs.
Is there still hope for Celgene shareholders who hold the $9 per share Contingent Value Rights tickets despite the cold water that seemed to dash the chances of required goals necessary for those payoffs?
President Trump has repeatedly assured U.S. citizens his administration would secure enough COVID-19 vaccine doses to protect the nation. However, a new report shows his government failed to act in securing additional doses of Pfizer and BioNTech’s vaccine this summer.
Pharmaceutical Research and Manufacturers of America (PhRMA), alongside other biotech industry trade organizations, filed a lawsuit Friday against the Trump administration’s new rules for lowering drug prices.
Experts anticipated his nomination as Biden’s Attorney General instead.