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 June 17, 2020.
The game was reviewed through the agency’s de novo pathway and as a result, creates a new class of digital therapeutics.
The warning came only a few hours after the FDA rescinded Emergency Use Authorization (EUA) for hydroxychloroquine and chloroquine for the treatment of COVID-19.
The approval was based on monotherapy clinical data from a trial in 105 adults with SCLC whose disease progressed after platinum-based chemotherapy.
Edesa Biotech, Inc. (NASDAQ:EDSA), a clinical-stage biopharmaceutical company, has received expedited approval from Health Canada to begin a Phase 2/3 clinical study of its investigational drug, EB05, which the company is developing as a potential treatment for moderate to severe COVID-19 patients.
The FDA indicated that, based on new evidence, there was not enough supporting evidence for the two drugs to be considered effective in treating COVID-19.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 15, 2020.
Although clinical trials are often performed throughout different parts of the world, often their demographic makeup—the gender, age and race of participants—has a certain kind of uniformity.
Two weeks after announcing concerns about high-levels of carcinogens in popular diabetes drugs, the U.S. Food and Drug Administration announced the first voluntary recalls of this class of drugs manufactured by five companies.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 12, 2020.