Policy
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
FEATURED STORIES
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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BMS partnered with digital oncology company GRYT Health to convene a series of “courageous conversations” between patients, practitioners, caregivers, clinical trial teams and public health leaders.
Stephane Bancel, the chief executive of Moderna, has likened the need for booster vaccine doses to the way Apple releases new smartphones every year.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
The delay is related to a third-party secondary packaging and labeling facility that Alnylam planned to use for the launch of vutrisiran.
Norman E. “Ned” Sharpless will step down from his role as director of the National Cancer Institute (NCI) at the end of this month, after serving in the role since 2017.
David Sabatini’s resignation follows a decision from three senior MIT officers that recommended his tenure’s revocation.
A former Harvard University professor of ophthalmology has retracted eight research paper abstracts published in professional journals over ethics concerns.
Two companies in India have halted vaccine manufacturing, which could be a sign that the pandemic may be coming to an end. For that and more COVID-19 news, continue reading.