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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 9, 2020.
The U.S. government is putting together the infrastructure for widespread distribution of a COVID-19 vaccine, if and when one is granted emergency use authorization (EUA) or full approval.
Using gene therapy to edit embryos, sperm or eggs in order to improve health conditions in a child should not be conducted due to the unreliability of the science, as well as due to significant ethical and moral concerns.Those are the words found in new guidance established this week.
Shares of Amarin Corporation are down more than 3% in premarket trading after the company reported Thursday that a panel of three judges from the U.S. Court of Appeals upheld a lower court’s ruling that paved the way for generic competition for the company’s heart disease drug, Vascepa.
When Moncef Slaoui was tapped to helm Operation Warp Speed, he sought confirmation that politics would not play a role in driving certain treatments through an approval process without the proper supporting scientific data to back it up.
It’s entirely possible that what we will be seeing most from the U.S. Food and Drug Administration for the month of September is related to treatments and vaccines for COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 4, 2020.
Could gene therapy provide a solution to HIV? A new research project aims to find out.
The U.S. Centers for Disease Control and Prevention (CDC) notified the public health departments in all 50 states and five large cities to prepare for the possibility of distribution of a COVID-19 vaccine by November 1.
Recently, the U.S. Centers for Disease Control and Prevention (CDC) made a regular data update on COVID-19 deaths. Unfortunately, the data, and how it was presented, was immediately misinterpreted.