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Passage launches strategic review and 75% layoffs after gene therapy path blocked by FDA

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After some tough feedback from the FDA on the path forward for its lead gene therapy, Passage Bio has launched a strategic review and set out a plan to whittle down its headcount by 75%.

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The commercial launch playbook: Team structure, readiness and execution

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Intellia Therapeutics’s Senior Vice President Maria Natale discusses why the most successful launches are shaped long before approval, with strategy, structure and patient insight at the core.

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Despite FDA trial clearance, ibogaine metabolite won’t receive red carpet treatment

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DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.

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Consummate chameleon Amylyx nears regulatory run in obesity surgery complication

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After suffering the market withdrawal of its only product, Amylyx is gearing up for a pivotal Phase 3 readout in post-bariatric hypoglycemia. But the company’s driving ethos is still to treat “debilitating, devastating” neurodegenerative diseases, co-CEO Justin Klee told BioSpace.

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