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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Scientists call for more investigation into the origin of the virus, particularly in China, but China now wants to include the U.S. in the probe.
The FDA granted it to Lu-PSMA-617, an investigational radioligand therapy to treat metastatic castration-resistant prostate cancer.
Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond its newly-approved aducanumab has hit a clinical snag after gosuranemab failed.
The U.S. FDA approved Ayvakit for the treatment of adult patients with advanced sytematic mastocytosis (SM), advanced SM, and mast cell leukemia.
Both MannKind and United Therapeutics entered into a global and exclusive licensing and collaboration agreement to develop and commercialize Tyvaso DPI.
Eli Lilly and Company announced Tuesday the launch of a head-to-head study to compare once-monthly injectable Emgality® (galcanezumab-gnlm) with Nurtec® ODT (rimegepant) for the prevention of migraine.
Please check out the biopharma industry’s COVID-19 stories that are trending for June 15, 2021.
The new division would benefit from Hahn’s experience and help steer the company’s Preemptive Medicine and Health Security initiative.
Besides providing a sense of hope for children with this devastating disease, this research could offer another clue toward unlocking the mystery behind other forms of ALS.
The EMA identified a rare blood condition, capillary leak syndrome, as a potential side effect of AstraZeneca’s Vaxzevria.