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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On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
ZYESAMI, (aviptadil), being assessed by NRx Pharmaceuticals, failed a review conducted by the Data Safety and Monitoring Board (DSMB), with the board recommending that arm of the trial cease.
Shares of Enochian Biosciences plunged more than 36% after the Justice Department announced company cofounder Serhat Gumrukçu was arrested in a sordid 2018 murder-for-hire scheme.
Antios Therapeutics received a clinical hold on its Hepatitis B virus (HBV) combinatorial therapy from the U.S. Food and Drug Administration on Wednesday.
Johnson & Johnson and Momenta Pharmaceuticals have filed a patent infringement lawsuit over a generic multiple sclerosis drug developed by India-based Natco, Gland Pharma and Mylan.
Concerns are mounting for people that have been given Pfizer’s Paxlovid treatment regimen after contracting COVID-19, only to become positive for the infection once again.
Monday, Moderna told a Delaware federal court that it was immune from patent-infringement charges over the COVID-19 vaccine because it supplied the vaccine for a U.S. government effort.
Vanda has again taken legal action against the FDA over its supposed failure to grant tradipant Fast Track designation. In its complaint, Vanda is challenging the FDA’s decision to deny the designation.
If approved, etranacogene dezaparvovec would be the first gene therapy treatment for hemophilia B.
The American Society of Clinical Oncology and the Association of Community Cancer Centers are combining their efforts to increase racial and ethnic diversity in clinical trials.