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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Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 4, 2020.
Less than one month after the White House zeroed in on 14 vaccine candidates for COVID-19, the administration has narrowed that list even more to five potential treatments for the prevention of the novel coronavirus.
On Tuesday, the FDA extended its review of the Supplemental Biologics License Application for Arzerra in this indication by three months.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 3, 2020.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 2, 2020.
U.S. Food and Drug Administration (FDA) Commissioner Stephen M. Hahn recently gave a speech to the Alliance for a Stronger FDA. In it, he suggested that some of the changes forced on the agency by the COVID-19 pandemic are likely to become permanent.
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
Although the U.S. FDA is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.