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.
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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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Based on topline data, Pfizer stated that three doses of the COVID-19 vaccine met all immunobridging criteria required for EUA. The FDA’s advisory committee will meet June 15 to discuss the matter.
Sunday night, U.S. health authorities announced that they may have found the third documented case of monkeypox in a patient in South Florida.
Alnylam Pharmaceuticals shared 18-month results from its phase III Helios-A clinical study demonstrating that vutrisiran improves clinical cardiac symptoms in patients with hATTR.
On Wednesday evening, a man in Massachusetts became the first person reported to have a case of monkeypox in the U.S. The man contracted monkeypox after traveling to Canada.
U.K. researchers found that the first dose of any vaccine was linked with an initial 12.8% decrease in the odds of Long COVID.
Following reports that Pfizer has declined study requests for Paxlovid, the company and NIH are said to be in conversation about potential studies assessing a longer treatment period of the antiviral.
Greece’s Health Minister Thanos Plevris announced plans to sue Novartis over what he alleges are illegal practices. In addition to demanding compensation, the country is implementing a three-point plan.
Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
Clay Siegall resigned his role as president, CEO and a member of the board of directors of Seagen following domestic violence allegations. Roger Dansey will serve as interim CEO.
The changes are unlikely to help people in developing countries but could reduce innovation among biopharma companies and ultimately do more harm than good.