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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Eli Lilly is seeking Emergency Use Authorization for its antibody therapy, LY-CoV555, for the treatment of high-risk patients with recently diagnosed mild-to-moderate coronavirus disease 2019 (COVID-19).
The new guidelines posted Tuesday by the FDA, call for vaccine developers to follow patients dosed with the experimental medication for at least two months before seeking Emergency Use Authorization.
In his resignation, Bright said that the Trump administration “ignores scientific expertise, overrules public health guidance and disrespects career scientists.”
Makena, the only FDA-approved treatment to reduce preterm birth failed to meet endpoints in a recent trial. The FDA gave notice of intent to withdraw approval.
Allele Biotechnology and Pharmaceuticals filed lawsuits claiming the companies infringed on Allele’s patented mNeonGreen technology in the development of their COVID-19 treatments.
In the October 2 verdict, Circuit Judge Pauline Newman said that promotional materials, press releases, product catalogs, FDA labels and witness testimony did support the “induced infringement” judgement against Teva.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for October 6, 2020.
The sticking point for the White House is a provision in the guidance that calls for vaccine manufacturers to follow people participating in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.
Philadelphia-based software company eResearchTechnology (ERT), which offers software used in hundreds of clinical trials, has suffered a ransomware attack.
The new high-speed test uses a high-throughput method comprising heat and technology to extract RNA from samples used for COVID-19 RT-PCR molecular testing.