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 trial was initially scheduled for July, but in April had been postponed until October due to the pandemic. A final decision will be made in August.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 20, 2020.
Wrapping up the month of July, there are three PDUFA dates on the U.S. Food and Drug Administration (FDA) calendar.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 17, 2020.
A dramatic increase in COVID-19 testing and tracing is needed in order to put the United States on a surer path through the pandemic. But that diagnostics increase comes with a significant price tag of about $75 billion from the federal government, the Rockefeller Foundation said in its latest report.
Shares of Mallinckrodt climbed after the company announced the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration voted to recommend approval for its investigational agent terlipressin to treat adults with hepatorenal syndrome type 1.
“We are pleased the committee recognized the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options,” said Axel Hoos, senior vice president and heat of Oncology R&D for GSK.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 15, 2020.
An unnamed U.S. official told the news agency that vaccine manufacturing under development in conjunction with the federal government’s Operation Warp Speed program is likely to begin within the next four to six weeks.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for July 13, 2020.