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
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
The tests revealed that some metformin products contained the presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the regulatory agency.
Michael Bell, M.D., deputy director of the Division of Healthcare Quality Promotion at the Centers for Disease Control, teamed up with the Pandemic Action Network to help answer such questions and combat misinformation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
Bristol Myers Squibb is doing its best to claim market share in the checkpoint inhibitor space and over the past month, the company is pushing its way forward with a pair of regulatory approvals in lung cancer.
To date, Dupixent is the only biologic approved for this age group.
Alnylam Pharmaceuticals’ lumasiran for a chronic kidney stone disease was granted Priority Review status by the U.S. Food and Drug Administration. It will have a target action date of December 3, 2020.