Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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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.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
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The advisory committee voted 19-0 to recommend the extra dose of the J&J shot for anyone 18 years and older.
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According to CNN, Califf is being vetted by the administration of Joe Biden, who served as vice president to Obama.
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Protagonist Therapeutics announced Monday morning that the FDA had removed the hold on PV drug candidate rusfertide, clearing the way for all trials to resume.
Biden’s campaign trail promise to cure cancer is hanging in the balance as his plan for a new biomedical research agency is being axed from the Democrats’ social spending package.
Two companies reported regulatory submissions to the FDA, and a third reported successful clinical trial data that will form the basis of submission in the coming months.
Acting FDA Commissioner Janet Woodcock’s days as interim head of the agency are numbered due to federal regulations. Speculations are rampant on a number of potential choices.
As US vaccination rates have been hovering in the 50% of the population range for two months, President Biden hit the old dusty trail to push his vaccine mandate even more.