Policy
Robert Kramer, former CEO of Emergent BioSolutions, allegedly earned more than $10.1 million by executing trades with information related to the company’s manufacturing operations that had yet to be made public.
FEATURED STORIES
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Sanofi announced yesterday that they will resume dosing in U.S. clinical trials. They noted that on October 30, they had “voluntarily paused dosing in all ongoing fitusiran clinical studies … to assess reports of non-fatal thrombotic events in patients participating in the Phase III program.”
The U.S. Food and Drug Administration (FDA), a day after a positive advisory committee recommendation, granted an Emergency Use Authorization (EUA) to Pfizer and BioNTech for their COVID-19 vaccine. Dosing is expected to begin in days.
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.
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?