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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AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for its treatment known as odevixibat, for pruritus in patients with PFIC.
One year and more than 410,000 deaths later, the United States is still firmly in the grips of the COVID-19 pandemic.
The drug, a combination of cabotegravir and rilpivirine, is a complete therapy for HIV-1 infection in adults who are virologically suppressed.
The U.S. FDA has accepted Genentech’s supplemental New Drug Application and has granted Priority Review for the company’s unclassifiable interstitial lung disease (UILD) treatment Esbriet® (pirfenidone).
Hours after being sworn in as the 46th President of the United States, Joe Biden signed 10 executive orders that are aimed at combating the ongoing COVID-19 crisis.
Rochelle Walensky, who most recently served as chief of the division of infectious diseases at Massachusetts General Hospital, will become the new head of the U.S. Centers for Disease Control and Prevention under the administration of Joe Biden.
The U.S. FDA has granted rare pediatric disease and orphan drug designations for Taysha Gene Therapies’ AAV9-based gene treatment candidate currently in development for epilepsy caused by SLC13A5 deficiency.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for January 19, 2021.
Daiichi Sankyo’s and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) has become the first HER2-directed medication approved to treat gastric cancer in the U.S. in 10 years.
Will there be enough doses of the two authorized mRNA COVID-19 vaccines to meet the lofty goal of 100 million inoculations within 100 days of the start of Joe Biden’s presidential administration?