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
According to a warning from federal officials last week, dozens of drug companies, universities and medical device manufacturers owe more than a decade’s worth of data from clinical trials.
The U.S. government is seeking $11 billion in civil and criminal penalties from Purdue Pharma as the maker of OxyContin winds its way through bankruptcy.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 5, 2020.
In its CRL, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications.
Russia’s minister of health, Mikhail Murashko, indicated that the country plans a nationwide program to vaccinate its population against COVID-19 starting in October.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 3, 2020.
August is a busy month on the U.S. Food and Drug Administration (FDA)’s calendar. Here’s a look at this week’s schedule.
The U.S. Department of Defense granted Monmouth Junction, New Jersey-based CytoSorbents Corporation a $4,421,487 three-year contract to complete preclinical development of its HemoDefend-BGA plasma and whole blood adsorber.
GlaxoSmithKline and Sanofi struck a $2.1 billion deal with the U.S. government’s Operation Warp Speed program to supply an initial 100 million doses of a COVID-19 vaccine candidate under development by the two companies.
The U.S. FDA issued a new template for clinical test developers that is designed to assist these companies in developing and submitting emergency use authorization (EUA) for COVID-19 tests that can be performed at home or in other settings besides laboratories.