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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
FDA
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.
Speaking to BioSpace in San Francisco, Elena Koundourakis, the head of the orexin franchise at Takeda Pharmaceuticals, gave a preview of what is ahead for its aims to treat narcolepsy.
If it feels like there has never been a tougher time to look for work, you’re not alone—and you’re likely not wrong.
Carina Clingman answers questions about forging professional connections in-person and on LinkedIn.
Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.
The German biotech is dropping $20 million upfront on two preclinical monoclonal antibodies for undisclosed targets developed by WuXi Biologics.
Analysts in life sciences play a crucial role in analyzing and interpreting data to support research, development and decision-making processes within the field.
Panelists at JPM’s Biotech Showcase gave positive projections as the year begins and offered advice to those in the space.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 3 at JPM2024.
Triumvira Immunologics’ president and chief operating officer Rob Williamson noted that cell therapy companies might still have an uphill battle unless they can differentiate.