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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In documents prepared for the meeting, the vaccine demonstrated 90.7% effectiveness for the children in this age group.
Scientists are scrambling to find the cause for the sudden spike in human cases of avian influenza A (H5N6) in China to 21 this year, from only five in 2020.
The battle between bluebird bio and Errant Gene Therapeutics has escalated into a patent lawsuit. Errant alleges that bluebird’s gene therapies infringe on their patents for recombinant vectors.
If the panel votes in favor of the vaccine for children, it will move to the U.S. CDC. If both agencies support the data, children this age would be likely to receive their first shots in early November.
Sio Gene Therapies had a few big announcements last week, including a Fast Track Designation from the U.S. Food and Drug Administration and the reorganization of its R&D group.
The ongoing criminal trial of Holmes revealed Elizabeth Holmes and Theranos issued marketing materials to future partner Walgreens that included the use of Pfizer’s corporate logo.
The U.S. FDA has a busy period at the end of October heading into the first week of November.
Two months after being ousted by the Whitehead Institute over allegations of sexual harassment, prominent cell biology researcher David Sabatini has filed a counter lawsuit.
The FDA placed a clinical hold on Tryp Therapeutics’ Phase IIa trial for eating disorders, including binge eating disorder and hypothalamic obesity.
The designation is based on data from two Phase I trials, which showed the drug to be safe, demonstrating early efficacy.