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 U.S. FDA placed a hold on the Emergency Use Authorization for convalescent plasma as a potential treatment for COVID-19 over what was described as a lack of robust data supporting its use.
“We are grateful to the NIA for their rigorous scientific review and funding support to advance ALZ-8801 for Alzheimer’s patients in need of an effective treatment,” said Martin Tolar, founder, president and chief executive officer of Alzheon.
The agency indicated that they had completed the review cycle for the application but the application was not ready for approval in its current form.
The company indicates the agency requested data from the MANTA and MANTA-Ray trials before completing its review of filgotinib. Here’s more about it.
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
The legal ruling, subject to appeal, protects the Swiss pharma giant’s revenue stream from the blockbuster drug Gilenya for a little bit longer.
Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S. Food and Drug Administration halted a cancer drug trial due to safety concerns.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
In the midst of an international pandemic, three high-profile public health officials are leaving government service.
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.