Regulatory
All eyes on the FDA as they review a COVID-19 vaccine, FDA approval of an Emergency Use Authorization to LabCorp’s home test kit for COVID-19, the first testing device that does not require a prescription and more news.
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.
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?
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
Check out some news happening today around the biopharma industry.
Yesterday, the United Kingdom’s MHRA granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.
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