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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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Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.
A one-time treatment for Parkinson’s disease could be a ‘market changer,’ experts told BioSpace, adding that cell therapies could limit the adverse effects seen with current drugs.
Drugmakers, including the genetic testing company 23andMe, are using novel approaches to stimulate NK cells’ intrinsic ability to recognize and kill tumor cells.
In this deep dive, BioSpace takes a closer look at the drug price crisis in the U.S. As President Joe Biden and former President Donald Trump gear up for a rematch in the 2024 election, we explore how federal reforms to lower costs could be leveraged on the campaign trail.
The clinical-stage biotech emerged from stealth on Thursday with several oral and injectable candidates, including a GLP-1 receptor agonist in Phase I trials, in an effort to challenge Novo Nordisk and Eli Lilly.
The FDA will close out April with five target action dates around indications that include pediatric seizures and a neurological cancer in children.
Data from the Phase III OCARINA II study shows the subcutaneous version of Ocrevus achieved near-complete suppression of relapses and brain lesions in relapsing or primary progressive multiple sclerosis.
Teva Pharmaceuticals and Alvotech got the FDA’s greenlight for their biosimilar to Johnson & Johnson’s blockbuster Stelara, which will launch in the U.S. in February 2025.
Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.