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The rehired staff, who number around 460, work with the CDC’s viral disease prevention efforts and sexual health testing labs, among others. The reinstatements are a ray of light in an acrimonious week that also saw protests and the complete overhaul of the agency’s vaccine advisory committee.
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The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access.
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
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Athira Pharma will cut about 49 positions, including two people in the C-suite. The announcement follows the company’s disappointing results for its investigational Alzheimer’s therapy.
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Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention.
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In this episode of Denatured, presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses how AI transformation can help organizations navigate a rapidly evolving regulatory environment with senior director of regulatory innovation and technology, Michelle Gyzen.
Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on target for a Q1 2026 submission for its one-time gene therapy for Huntington’s disease—but patients have been here before.
The Platform Technology Designation, which predates the current FDA leadership, is designed to streamline the drug development and review process, particularly for rare diseases.
The lawsuit alleges that HHS leadership knew the records they used to guide their layoff decisions were inaccurate and contained errors.
Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.
Looking for a biopharma job? Check out the BioSpace list of 12 top companies hiring life sciences professionals like you.
Massachusetts’ life sciences jobs grew by just 0.03% in 2024, according to a new MassBioEd report. Still, the report found encouraging signs for the industry, noting it’s expected to grow by 11.6% by 2029, adding an estimated 16,633 net new positions.
Disappointing results for iluzanebart come shortly after Vigil Neuroscience struck a buy-out deal with Sanofi, but analysts say the outcome is unsurprising and shouldn’t affect the deal.
Eli Lilly joins up with Camurus to make long-acting versions of the pharma’s obesity and diabetes drugs, joining the industry’s growing pipeline of programs that are differentiated by the frequency of dosing.
The FDA plans to “rapidly make available” rare disease drugs and make use of surrogate endpoints to get promising medicines to patients before they clear the traditional efficacy bar for authorization, Prasad said Tuesday.