The Food and Drug Administration has moved to test a faster model for reviewing trial results, unveiling what it calls real-time clinical trials and pairing the effort with two early-stage studies from AstraZeneca and Amgen. In a statement, commissioner Marty Makary said the aim is to cut the delay between data generation and regulatory assessment, with the agency arguing that closer-to-live monitoring could eventually support continuous trials across all stages of drug development. According to the FDA, the pilot studies are intended to feed endpoints and safety signals to regulators as they emerge, rather than waiting for the usual end-of-study package.

The initiative fits into a wider push to modernise clinical research using data science and artificial intelligence, and the agency has suggested the approach could shorten drug-development timelines by as much as 20% to 40%. Axios reported that the first two proof-of-concept programmes involve AstraZeneca’s TRAVERSE study in mantle cell lymphoma and Amgen’s STREAM-SCLC trial in small cell lung cancer, both of which are designed to test whether real-time oversight can be made workable in practice. Clinical Research News said the FDA has already received and validated initial signals from AstraZeneca’s trial, suggesting the programme is moving beyond concept stage.

In a separate oncology deal, AbbVie has secured an exclusive option to buy Kestrel Therapeutics, a startup developing KST-6051, a pan-KRAS inhibitor for KRAS-driven cancers. Kestrel said AbbVie will help fund the drug’s development after its first-in-human trial began, and the acquisition price could rise to as much as $1.45 billion if agreed milestones are reached. The company says the treatment binds KRAS in both active and inactive forms, which it argues may give it a broader reach than competing approaches and could limit toxicity.

Meanwhile, other drugmakers continued to lean on partnerships and late-stage data to advance their pipelines. Pfizer said Elrexfio beat standard therapy in a Phase 3 study in multiple myeloma patients whose disease had returned after initial treatment, with an early look showing most participants remained progression free at the time of review. Eli Lilly also struck a new alliance with Profluent to develop bespoke enzymes for gene-editing medicines, in a deal that could be worth up to $2.25 billion. And GSK and Ionis said the FDA has accepted their application for bepirovirsen in chronic hepatitis B, setting a target decision date of 26 October as they seek approval for what they describe as a potential functional cure.

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Source: Noah Wire Services