Pharma Pulse 5/23/25: The Role of AI in Solving Clinical Trial Diversity and Access Challenges; FDA Advisors Unanimously Snub Pfizer's Talzenna in Broader Prostate Cancer Population

The Role of AI in Solving Clinical Trial Diversity and Access Challenges

In an interview with Applied Clinical Trials, Michel van Harten, MD, CEO of myTomorrows, explained how AI can help address clinical trial diversity and access challenges by reducing physician workload through treatment matching, simplifying patient education, and breaking down logistical and informational barriers that disproportionately affect underrepresented populations.

FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population

FDA advisors unanimously voted against expanding Pfizer’s Talzenna to a broader prostate cancer population without HRR mutations, citing flaws in trial design, insufficient statistical power, and concerns over toxicity, despite the drug showing survival benefits in a recent Phase III study.

Improving the Patient Experience and Lilly’s GI Treatment Pipeline: Q&A with Mark Genovese, MD

In an interview with Pharmaceutical Executive, Mark Genovese, MD, SVP, immunology development, Eli Lilly, highlighted how new data for Omvoh (mirikizumab) presented at DDW 2025 underscore the company’s commitment to improving the patient experience in inflammatory bowel disease through symptom relief, long-term remission, and innovations like citrate-free formulations, while also advancing a robust gastrointestinal pipeline that includes pediatric studies, combination therapies, and next-generation oral treatments.

Overcoming Metallo-β-Lactamases: A Review of Cefepime-Taniborbactam

Cefepime-taniborbactam is a promising novel antibiotic combination showing potent activity against metallo-β-lactamase–producing and other resistant gram-negative bacteria, with clinical trial data demonstrating superiority over meropenem for complicated urinary tract infections and the potential to address critical unmet needs in antimicrobial resistance.

Safeguarding Patient Health During Natural Disasters: Lessons from the Recent California Wildfires

Specialty pharmacies and infusion centers play a critical role in safeguarding patients with complex conditions during natural disasters by implementing comprehensive emergency preparedness plans focused on communication, operational continuity, community collaboration, and patient empowerment to ensure uninterrupted access to essential medications and therapies.