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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Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 26, 2020.
Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration has a number of drug approvals on the calendar. Here’s a look.
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 22, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 21, 2020.
The U.S. Biomedical Advanced Research and Development Authority (BARDA) paid more than $1 billion to support the development, production and delivery of the vaccine beginning this fall.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 20, 2020.
Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
As part of the agreement, Phlow will help build the United States’ first Strategic Active Pharmaceutical Ingredients Reserve, a long-term, national stockpile to secure key ingredients used to manufacture the most essential medicines in the United States.
Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.