FDA pilots real-time clinical trials as Amgen, AstraZeneca join proof-of-concept studies; AbbVie eyes KRAS biotech Kestrel
The U.S. Food and Drug Administration announced a pilot program for "real-time" clinical trials, designed to cut the lag between data collection and regulatory review.
AstraZeneca and Amgen have launched two proof-of-concept cancer studies under the new approach, agreeing to send endpoint and safety data to FDA scientists as the information becomes available.
AbbVie secured an option to acquire Kestrel Therapeutics, a startup developing a drug that targets multiple KRAS mutations. The company will fund KST-6051, which has just entered its first human testing phase.
These actions illustrate a broader push within the industry to speed drug development and secure promising oncology assets.
This writeup was produced by pharmadog from original reporting by BioPharma Dive.
Original headline: “FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech”
read at BioPharma Dive ↗
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