Government
As the year wraps up, there are still some PDUFA dates on the agency’s calendar. Read on for this week’s.
If the U.S. Food and Drug Administration does not grant Emergency Use Authorization to the COVID-19 vaccine developed by Pfizer and BioNTech, the White House will demand the resignation of FDA Commissioner Stephen Hahn.
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.
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.
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.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
PRESS RELEASES