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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With no permanent commissioner, the U.S. Food and Drug Administration appears to be both cracking down on Accelerated Approvals while struggling with a backlog of inspections.
In the wake of an increasingly accelerated COVID-19 vaccine rollout, the CDC has released new guidance statements that give fully vaccinated individuals more freedom to socialize and participate in pre-pandemic activities.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for March 9, 2021.
The Russian government is attempting to cast a negative light on the COVID-19 vaccine developed by Pfizer and BioNTech, as well as other vaccines, in order to boost sales of its own vaccine, Sputnik V, the government charged.
KemPharm announced this week that the U.S. Food and Drug Administration has approved its novel ADHD drug for use in patients six years and older.
Advocates from the ALS community flooded the FDA with letters, Tweets, emails, videos and other comments expressing their anger over the rejection and the frustration that there are few therapeutics for a disease that is a delayed death sentence.
GE Research selected DNA Script to join a collaboration working on a rapid response, mobile platform to develop on-demand production of nucleic acid-based vaccines and therapies related to biological threats.
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.
The U.S. FDA has decided to put together an advisory committee meeting of outside experts to review a New Drug Application for roxadustat, FibroGen and its partner AstraZeneca’s investigational anemia therapy.