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 October doesn’t appear to be a very busy month for the U.S. Food and Drug Administration’s PDUFA dates, there are a few. Here’s a look at the next two weeks.
At 74 years old, Trump is in a category of older Americans who are at more vulnerable to infection, and at higher risk of developing more serious symptoms.
In mid-August, the FDA’s Oncologic Drugs Advisory Committee voted 9 to 1 to recommend the drug for that indication. Although the agency isn’t required to follow an advisory committee’s recommendation, it usually does.
AstraZeneca’s Phase III COVID-19 vaccine study in the United States is being further delayed due to the U.S. FDA wanting to take a more thorough look at information related to the trial.
PF-06939926 is currently being evaluated to determine the safety and efficacy of this gene therapy in boys with DMD.
The trial was initially placed on hold in November 2019 due to safety concerns.
Catalyst Pharmaceuticals is reeling this morning after a federal judge dismissed the company’s lawsuit against the U.S. Food and Drug Administration regarding the approval of a rival drug for a rare autoimmune disease from New Jersey-based Jacobus Pharmaceutical.
California Gov. Gavin Newsom signed Senate Bill 852 into law on Monday, paving the way for California to manufacture cheaper versions of insulin and other drugs that have been in short supply in recent years.
More than one month after the government of Russia announced it approved the world’s first vaccine for COVID-19, it announced it will share preliminary data from the first six weeks of the ongoing Phase III study.
The company plans to submit its biologic license application (BLA) to China’s National Medical Products Administration (NMPA) and other regulators worldwide.