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 move was announced due to the advisor’s role in overseeing a clinical study for Moderna’s mRNA vaccine candidate.
Under that designation, Mereo may qualify for a voucher that can be used for a priority review of a subsequent marketing application for a different product than Setrusumab.
If that guidance comes to pass, it would delay potential EUA of a vaccine until the end of 2020 or early 2021 – well after the Nov. 3 election.
Although the updated guidance has largely remained under wraps, sources who spoke to The Washington Post hinted that the new rules would make it more difficult for an EUA to be granted to a vaccine ahead of Nov. 3, the day of the U.S. elections.
In a brief statement, Genmab said it initiated binding arbitration related to two matters under its Darzalex (daratumumab) license agreement with Janssen Biotech.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 2, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 30, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 28, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 25, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 23, 2020.