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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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Despite the benefits of hiring foreign-born STEM employees, some companies avoid it largely due to unfamiliarity with the visa process, according to two recruitment experts.
This is the first round in a series of cuts that will cost 75 people their jobs this year, according to a WARN notice. Employees in other states are affected as well.
While Sanofi restructures and parts with employees from U.S. and Belgian sites, a new company in the GLP-1 space emerges from stealth.
While Bristol Myers Squibb did not explicitly mention China as the company expands and diversifies its manufacturing capacity, Cellares said the BIOSECURE Act would be a boon to its own growth.
As the Phase III amyotrophic lateral sclerosis pipeline thins out, the ALS community is placing its hopes on earlier-stage trials sponsored by Denali Therapeutics, PTC Therapeutics and more.
The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.
CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.