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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The FDA granted Merck’s investigational 21-valent pneumococcal conjugate vaccine (V116) for IPD and pneumococcal pneumonia Breakthrough Therapy Designation.
Protagonist disclosed the FDA issued a letter of intent to rescind the status for rusfertide based on concerns first raised in a clinical hold placed on the drug.
The FDA has sprung into action, cracking down on the illegal sales of Adderall, as well as on CBD companies making claims their products are effective treatments or cures for COVID-19.
As Martin Shkreli, Elizabeth Holmes and Sunny Balwani, and the Purdue bankruptcy deal play out, there is even more drama beyond the stories–a failure to pay legal fees.
Myovant said that the FDA provided notice it had found deficiencies that will preclude any potential discussion of labeling or post-marketing requirements at this time.
As Aeglea presents the data this week at the Society for Inherited Metabolic Disorders (SIMD), its stock has responded to both announcements with a strong leap.
Following the decision to limit the coverage of Biogen’s controversial Alzheimer’s drug Aduhelm, the Alzheimer’s community is now waiting for other companies to deliver new therapies.
The FDA is looking at revising the current vaccine strategy and emphasizing that individuals need to consider their own risk tolerance. For that and more, continue reading.
The new bills result from a three-year investigation that honed in on anti-competitive efforts that have prevented generic drugs and biosimilars from entering the market.
Janssen Pharmaceutical, under parent organization Johnson & Johnson, secured an arbitrary win this week that results in royalty decisions stemming from licensing and marketing of daratumumab.