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STAT+: FDA’s new guidance on AI in drug development centers the risk introduced by the technology

STAT

In an interview with STAT in October, the FDA’s Tala Fakhouri, who co-leads the Center for Drug Evaluation and Research’s AI Council, said the agency has received over 500 drug submissions with AI components since 2016, with a large number in the areas of oncology, neurology, and gastroenterology. 

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Opinion: U.S. taxpayers should stop funding clinical trials of industry-owned drugs

STAT

The National Cancer Institute (NCI) has had a taxpayer-funded drug development program for nearly 70 years, initiated at a time when there was no private investment in oncology drugs

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GRIN Therapeutics: Seeking to address unmet needs in rare neurodevelopmental disorders

pharmaphorum

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Can rare disease research in the US thrive under the new administration?

Pharmaceutical Technology

Given the way the Hub is set up, it can closely engage with the rare disease community—biotechs, advocacy organisations, and more—without conflicts since it is not involved with the drug review process. Moreover, other threats to the early-stage drug development for rare diseases are also a concern.

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Why security-first design is the fix to stalling AI pilot tools

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024). After all, this is what incentives are for.

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Update: Rumour confirmed as Lilly buys Verve Therapeutics

pharmaphorum

billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023. billion takeover bid for Verve Therapeutics, upgrading a collaboration between the two companies that dates back to 2023.