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 National Institutes of Health is raising concern about the safety of AstraZeneca’s coronavirus vaccine, even as the U.S. FDA is weighing whether or not to resume testing in the United States following a global pause in the trial for safety reasons.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 16, 2020.
Only days after saying it expects to have key data from its Phase III clinical trial of its COVID-19 vaccine in October, Germany’s BioNTech received a grant of up to €375 million from the German Federal Ministry of Education and Research.
The United Arab Emirates has granted Emergency Use Authorization to an investigational vaccine for the novel coronavirus six weeks after late-stage studies began.
President Donald Trump expanded the number of drugs covered under a “favored nations clause” by Medicare Part D and Medicare Part D with a new Executive Order intended to lower the cost of prescription drugs in the United States announced Sunday.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 14, 2020.
Six months into a global pandemic and public trust is waning in its support for public health officials in charge of the nation’s response to the novel coronavirus, according to a new poll.
Elizabeth Holmes, the founder and former chief executive officer of failed diagnostics company Theranos, will be examined by a psychologist and psychiatrist ahead of her looming trial for fraud.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for September 11, 2020.
GlaxoSmithKline’s Trelegy Ellipta won regulatory approval for the treatment of asthma in patients aged 18 years and older. Here’s what you need to learn.