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Despite an overall survival miss, Leerink Partners said Pfizer’s antibody-drug conjugate showed “promising” signals of efficacy in a subgroup of patients who had undergone only one prior line of treatment.
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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.
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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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.
The Massachusetts–based startup will use the Series A funds to advance its pipeline of oral GPR17, CSF1R and TYK2 candidates.
Patients treated with AR-15512 showed higher rates of at least a 10-mm improvement in unanesthetized Schirmer’s score, a metric of tear production.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 2 at JPM2024.
All assets of the regenerative medicine and cell therapy company are being divested to its research partner to the tune of $2 million in the form of a credit bid.
The Alliance for Regenerative Medicine predicts up to 17 cell and gene therapy approvals this year and defends high prices, while FDA’s Peter Marks expresses concern about manufacturing costs.
Following in the footsteps of Novartis, J&J and Merck, GSK jumped into the J.P. Morgan dealmaking frenzy Tuesday, picking up respiratory and inflammation-focused Aiolos Bio.
Vertex still has an ongoing diabetes partnership with CRISPR, which gives it a non-exclusive license to the latter’s platform to develop a potential cure for type 1 diabetes.