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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The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug application that will allow Boston-based Vertex Pharmaceuticals to proceed with a clinical trial of its investigational stem cell-derived, fully differentiated pancreatic islet cell treatment for type 1 diabetes (T1D).
February is kicking off with a number of PDUFA dates for the U.S. FDA as well as a cancer advisory committee meeting. Here’s a look.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
The U.S. Department of Justice is set to recover more than $3 billion this year from pharmaceutical and medical device manufacturers as well as healthcare providers, labs and pharmacies found guilty of healthcare fraud under the False Claims Act.
The FDA is on a roll granting approvals. Three companies announced IND updates today.
A special fund for vaccine research that was set aside by the U.S. Department of Health and Human Services in 2010 has been misused to pay for unrelated expenses, a government report shows.
Senior White House adviser Andy Slavitt said the administration is striving to meet its goal of ensuring enough vaccine supply by summer, but acknowledged there could be some hurdles that will prevent that timeline.
Police have sealed off the area, according to the report. Few details were available, but eye witnesses said a robot was investigating a suspicious package found at the plant.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 26, 2021.
Pfizer, Moderna, AstraZeneca, and Johnson & Johnson all have trials of their respective vaccines underway in various age-groups.