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Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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In this third episode of Denatured’s series on AI in drug discovery, we discuss patient behavior and its influence on clinical trials and AI models with guests from GSK, IQVIA, Exelixis and DataHow.
ALTO-300 was significantly more effective in major depressive disorder patients with a specific EEG biomarker than in those without, according to results from an Alto Neuroscience Phase IIa study.
The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
EyePoint Pharmaceuticals’ treatment for wet age-related macular degeneration showed comparable results to Regeneron’s Eylea with a less frequent dosing regimen.
In the latest example of big pharma entering AI collaborations or using AI-based tools, AstraZeneca’s deal with Absci will aim to produce an oncology candidate.
The acquisition will give Roche access to Carmot’s clinical portfolio of three GLP-1 receptor agonists, placing it squarely in the middle of the competition to treat overweight and obesity.
The European Medicines Agency is seeking additional information from the makers of GLP-1 drugs as part of its ongoing review of the potential risk of suicide and self-harm thoughts associated with the class.
Lilly’s Jaypirca (pirtobrutinib) can now be used to treat chronic lymphocytic leukemia or small lymphocytic leukemia that had progressed from at least two prior lines of therapy, in addition to its previously-approved indications.
Johnson & Johnson’s AI investments include a research facility in San Francisco and a data science workforce of approximately 6,000 employees.
AbbVie’s $10.1 billion ImmunoGen buy and Altimmune’s Phase II win demonstrate that the antibody-drug conjugate market is red hot in cancer and GLP-1 drugs for weight loss are an absolute craze.