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The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay Prasad in November, was criticized for lacking detailed guidance. Agency leaders elucidated on the pathway for personalized medicines on Monday.
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The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last year’s ‘stampede’ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-β agonists and combination treatments, that seek to mirror the commercial success of Madrigal’s Rezdiffra.
Maintaining America’s momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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With its first-in-class endothelin and angiotensin II receptor antagonist Filspari, Travere Therapeutics is providing a more efficacious treatment option for the rare autoimmune disease.
With GLP-1 agonists slated to become the best-selling drugs in 2024, the biopharma industry is already pivoting to explore treatments that preserve muscle mass as patients shed pounds.
Humira maintained its blockbuster status and market share dominance in the first quarter of 2024, but experienced a drop in sales as biosimilar competition heated up, AbbVie reported on Friday.
Gilead on Thursday reported revenue growth in the first quarter of 2024, driven by the strong sales of its HIV, cancer and liver diseases franchises, while culling a number of candidates.
Starting in June 2024, Evernorth Health Services will offer Humira biosimilar products with no out-of-pocket cost through its Accredo specialty pharmacy.
With its lawsuit filed against Pfizer and BioNTech, the British multinational biopharma has joined the high-profile patent battle over mRNA technology used in COVID-19 vaccines.
Pfizer will go toe-to-toe with CSL Behring following the FDA’s Friday approval of its hemophilia B gene therapy Beqvez and will launch a warranty program based on the durability of response.
The genetic engineering startup, recently honored by BioSpace readers for its work environment, is downsizing as it seeks to launch its first clinical trials.
Is there a connection between Bristol Myers Squibb’s announcement that it will reduce its headcount by 6% and the company’s recent acquisitions of Karuna, Mirati and RayzeBio?
Several companies—including Roche, Curemark and Yamo Pharmaceuticals—are running clinical trials of treatments that aim to offset the myriad challenges of autism.