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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President Trump has repeatedly assured U.S. citizens his administration would secure enough COVID-19 vaccine doses to protect the nation. However, a new report shows his government failed to act in securing additional doses of Pfizer and BioNTech’s vaccine this summer.
Pharmaceutical Research and Manufacturers of America (PhRMA), alongside other biotech industry trade organizations, filed a lawsuit Friday against the Trump administration’s new rules for lowering drug prices.
Experts anticipated his nomination as Biden’s Attorney General instead.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 8, 2020.
Due to the registration potential of the mid-stage studies, the U.S. Food and Drug Administration requested the company complete a standard safety study, which amounts to a partial clinical hold on the study.
Governments across the globe have flexed their financial muscles to secure promises of as many doses of COVID-19 vaccines as possible when they become available.
Check out some news happening today around the biopharma industry.
As if attempting to steal hard-won research wasn’t bad enough, hackers are now hitting people where it really hurts – with e-documents containing malicious code embedded in false offers of employment.
Yesterday, the United Kingdom’s MHRA granted temporary authorization for emergency use to Pfizer and BioNTech for their COVID-19 mRNA vaccine. It didn’t take long for the decision to generate criticism and questions.
the robustness and independence of FDA review – even under an EUA – is an important factor in encouraging a skeptical public to accept COVID-19 vaccinations.