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
The Prescription Drug User Fee Act (PDUFA) was first passed into law by the U.S. Congress in 1992.
A U.S. Patent and Trademark Office administrative court rejected Moderna’s arguments that Arbutus’s ‘069 patent should be revoked because it “described obvious concepts.”
This morning, AstraZeneca announced the approval of the triple-therapy Breztri Aerosphere as a maintenance treatment for COPD.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 24, 2020.
Francis Collins, the director of the NIH, told STAT they were “really well-powered, rigorously designed clinical trials.”
“Hopefully the approval process will go very quickly, and we think we have a winner here,” Trump told White House reporters on Wednesday.
The U.S. Food and Drug Administration (FDA) approved Xywav, the first new treatment option indicated for both cataplexy and excessive daytime sleepiness in people living with narcolepsy in more than 15 years.
Two Chinese nationals have been indicted for hacking into the computer systems of hundreds of companies, governments, non-governmental organizations and more to steal trade secrets, including data on treatments related to COVID-19.
Only days after announcing a COVID-19 vaccine production deal with the UK government, New York-based Pfizer and Germany-based BioNTech signed an even bigger deal with the U.S. government.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 22, 2020.