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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 recent scientific advances, milestone approvals and increased dealmaking, the future of treatment for neurological diseases looks brighter—but continued investment, collaboration and patient-focused efforts are key.
The two agreements announced Thursday will allow AbbVie to leverage Umoja Biopharma’s VivoVec delivery platform, which enables patients’ cells to produce their own cancer-fighting CAR-T cells.
The regulator is launching an investigation of Novo Nordisk’s Wegovy, Eli Lilly’s Zepbound and other GLP-1 receptor agonists following patient reports of suicidal ideation, alopecia and aspiration.
In the third deal in as many days, Roche is paying $66 million upfront to MOMA Therapeutics to find new drugs to go after cancer cell growth, with a potential $2 billion total in milestones and royalties.
Wednesday’s settlement resolves a legal dispute between Daiichi Sankyo Europe and Esperion Therapeutics regarding milestone payments under their cardiovascular drug collaboration.
The late-stage pharmacokinetic study was stopped early due to efficacy at interim analysis, Lyndra Therapeutics said Thursday. A six-month safety study will start in the second half of 2024.
BioSpace and guests from Halia Therapeutics, Triumvira Immunologics and the Alzheimer’s Drug Discovery Foundation discuss alternative financing strategies to consider for 2024. Listen now.
Novo Nordisk’s partnerships with Flagship Pioneering-backed Omega and Cellarity, each worth up to $532 million, will explore novel treatment approaches to obesity and metabolic dysfunction-associated steatohepatitis.
With a PDUFA date in the second quarter of 2024, Pfizer is poised to compete with CSL Behring, whose Hemgenix became the first FDA-approved gene therapy for hemophilia B in November 2022.
The Interface Biosciences co-founder said forging the relationships needed to launch a startup can be a challenge for members of underrepresented groups, making confidence and adaptability key.