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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.
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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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Vertex Pharmaceuticals and CRISPR Therapeutics have secured another FDA approval for their Casgevy Cas9 gene-edited cell therapy, this time in treating transfusion-dependent beta thalassemia.
Disco Pharmaceuticals is taking to the biotech dance floor with seed funding from major players and pipeline programs in small cell lung cancer and colorectal cancer.
The biotech Tuesday announced a restructuring plan as its humanized IgG1 antibody lirentelimab failed two Phase II studies in atopic dermatitis and chronic spontaneous urticaria.
The snacks and confectionery giant has been seeking to enter the biopharmaceuticals space in recent years.
Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.
Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.
After a quiet start to 2024, the FDA is expected to decide on three applications over the next two weeks, including one for a nasal powder migraine treatment.
The agency nevertheless said that it could not definitively rule out a small risk of suicidal ideation associated with GLP-1 receptor agonists, and that it will continue evaluating the evidence.
Dropping the potential Cytokinetics buy runs contrary to Novartis’ recent dealmaking frenzy, which included the acquisition of Calypso and three research collaborations.
Biogen gained exclusive ex-U.S. rights to Ampyra in 2009 and is selling the drug under the brand name Fampyra in international markets.