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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Although many cyber criminals have pledged not to attack healthcare providers during the COVID-19 pandemic, one expert tells CNBC that this may not extend to pharmaceutical companies.
The designation will expedite regulatory review of the medication should it prove to be safe and effective.
This morning, the companies announced the regulatory agency issued a Refusal to File letter regarding the BLA for idecabtagene vicleucel (ide-cel; bb2121) for patients with heavily pretreated relapsed and refractory multiple myeloma.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 13, 2020.
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
The government has added additional charges of conspiracy, wire fraud, and forfeiture.
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.