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STAT+: FDA launches effort to speed up clinical trials, using AI
WASHINGTON — The Food and Drug Administration on Tuesday announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen.
The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment in clinical trials.
AstraZeneca is conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of its treatment for small cell lung carcinoma. The trials will rely on a real-time data platform built by Paradigm Health.
WASHINGTON — The Food and Drug Administration on Tuesday announced efforts to make clinical trials more efficient, starting by reviewing data in real time from trials conducted by AstraZeneca and Amgen.
The agency also asked the public to weigh in on a potential pilot program to work with companies that use AI to enhance safety monitoring and medication dose selections, identify safety signals, and improve patient recruitment in clinical trials.
AstraZeneca is conducting a Phase 2 trial of its combination therapy for patients with an aggressive form of lymphoma. The trial will take place at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of its treatment for small cell lung carcinoma. The trials will rely on a real-time data platform built by Paradigm Health.
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STAT+: Johnson & Johnson advances IBD therapy, despite trial miss
A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients.
On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD.
Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination therapy performed better than the individual drugs, but did not meet the primary endpoint of clinical remission.
A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients.
On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD.
Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination therapy performed better than the individual drugs, but did not meet the primary endpoint of clinical remission.
A subsidiary of Indian drugmaker Hetero Group mistakenly packaged two types of antidepressants in packs of sertraline, potentially posing risks to patients.
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The Boston-based company
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