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.
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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.
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Parker H. “Pete” Petit, the former chief executive officer of wound care company MiMedx was convicted of fraud and making false statements to the U.S. Securities and Exchange Commission, following a months-long investigation into the company’s financial records. William Taylor, the company’s former chief operating officer, was also found guilty.
The World Health Organization (WHO) recommends against using Gilead Sciences’ remdesivir as a treatment for COVID-19.
The EUA for the combination of Olumiant and Remdesivir marks the first combination for COVID-19 greenlit in the U.S.
With limited doses currently available, the logistics of inoculation are in the works and will certainly require guidance from the outgoing and incoming administrations of Donald Trump and Joe Biden, respectively.
The U.S. FDA has lifted a clinical hold on Cellectis’ Phase I MELANI-01 trial evaluating multiple myeloma candidate UCARTCS1 just months after working with the French biopharmaceutical company to adjust its trial protocol to enhance patient safety.
A settlement valued at $8.34 billion was reached between Purdue Pharma and the Justice Department on Tuesday, which required the drug company to plead guilty to three felonies related to its marketing and distribution of OxyContin.
The U.S. Food and Drug Administration has four distinct approaches to speeding the drug approval process. Several of today’s announcements had one or more of these designations.
With Pfizer and Moderna lining up their COVID-19 vaccine candidates for EUA, the U.S. FDA announced it will make publicly available all data and information that will be used to consider authorization of vaccines and therapeutics against the virus.
The two companies received Complete Response Letters from the FDA this week, along with Sanofi.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for November 17, 2020.