Feature|Videos|January 2, 2025
The Future of Regulatory Processes in Cell and Gene Therapy
Transferring knowledge and continuing to work together with regulatory agencies will lead to changes in approval going forward.
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Episodes in this series
Regulatory agencies are open to changes within the review process which means the uptake of CAR T-cell therapy will change the landscape itself. This is especially true with large-scale commercialization. Information sharing between global agencies will also be helpful in advancing the science forward.
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The Treasury Department is proposing rules to add biotechnology to its Outbound Investment Security Program under the COINS Act.
Gilead agrees to acquire an oral IL-23R inhibitor from PepStar, while Zymeworks licenses its DLL3-targeting T cell engager ZW209 to Roche.
Incubate’s John Stanford on why MFN is voluntary in name only — and why the moonshot is the first casualty of drug pricing pressure.
FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.
Alcon is acquiring Neurotech Pharmaceuticals to add the only FDA-approved MacTel cell therapy to its retina portfolio, while AI Proteins has enters a collaboration with Astellas to design novel miniprotein therapeutics.
FDA has granted accelerated approval to Ultomiris based on Phase III data showing a 43.4% placebo-adjusted reduction at 34 weeks.
A new ICER and West Health report finds median drug launch prices climbed to $257,000, the FDA approves GSK’s Hibsago as the first functional-cure therapy for chronic hepatitis B, and CSL names Deborah Waterhouse as CEO and managing director.
Median Drug Launch Prices Hit $257,000 as Access Barriers Persist, ICER and West Health Report Finds
Median net launch prices for new drugs climbed between 2022 and 2025 to $257,000, according to a new ICER and West Health report that also found persistent coverage and access barriers for patients.
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Trending on PharmExec
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Roundup: Gilead Acquires Oral IL-23R Inhibitor From PepStar for $1.275 Billion, Zymeworks Licenses DLL3-Targeting T Cell Engager to Roche
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FDA Approves Hibsago (Bepirovirsen) for Chronic Hepatitis B
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FDA Grants Ultomiris Accelerated Approval in the U.S. for Adults with Primary Immunoglobulin A Nephropathy
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Pharmaceutical Executive Daily: FDA Grants Ultomiris Accelerated Approval in the U.S.
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