Oct. 9, 2025
| This week’s gene therapy news and insights for biopharma leaders
The agency will consider a submission that includes pooled data from ongoing studies, a decision analysts viewed as a notable, additional sign of regulatory flexibility for gene therapies.
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The Italian drugmaker will pay as much as $115 million in upfront and near-term payments in a deal that gives it rights to a treatment in early-stage testing for primary hyperoxaluria type 1.
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Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.
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Artificial intelligence promises a major revolution for biopharma, from drug discovery to clinical trials. Explore how Bristol Myers Squibb uses AI to validate drugs before they’re even in the lab in
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Medical meetings often feature important clinical trial results, making them barometers of biotech and pharma companies’ research progress. Here’s a list of conferences to watch next year.
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News roundup
The decision to clear another mifepristone generic sparked political backlash. Elsewhere, investors will pump up to $175 million into Ovid after the company reported early, but encouraging, data for a potential epilepsy drug.
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UPDATED
Expedition Therapeutics, a startup aiming to in-license drugs from China, raised $165 million in the third nine-figure Series A round announced in the last three days.
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The Wall Street Journal
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STAT
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Genetic Engineering & Biotechnology News
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