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Harpreet Singh, MD, notes that the FDA’s broader shift toward accepting single pivotal trials reflects an evolution in regulatory thinking, while noting the agency still weighs disease severity, unmet need, trial design, and long-term safety

In today's Pharmaceutical Executive Daily, Reuters reports that lower-priced oral GLP-1 pills from Eli Lilly and Novo Nordisk are drawing patients away from compounded weight loss medications, Gilead Sciences' renews its five-year collaboration with WHO and Johnson and Johnson’s collaboration with the Department of Health Abu Dhabi, finally Partha Anbil argues that truly industrializing machine learning and AI in life sciences requires systems that are scientifically credible, clinically defensible, regulatorily traceable, and operationally sustained.

Life science organizations that will lead the next decade ar those that deploy systems that are scientifically credible, clinically defensible, regulatorily traceable, and operationally sustained.

New partnerships from Gilead Sciences and Johnson & Johnson highlight how healthcare companies are using collaborations to expand global disease initiatives and accelerate development of AI-enabled healthcare infrastructure.

Lower-cost oral obesity drugs from Novo Nordisk and Eli Lilly are drawing patients away from compounded GLP-1 therapies, according to interviews with U.S. doctors from Reuters, signaling shifting market dynamics as branded oral treatments expand access and intensify competition in the obesity space.

Kevin Dondarski from Deloitte Consulting discusses how changes in industry trends are causing pharma companies to explore new market opportunities provided by the rise of GLP-1 medications.

Harpreet Singh, MD, says understanding regulatory precedent, division-level dynamics, and the agency’s data-driven culture is critical for biopharma sponsors navigating today’s oncology approval landscape.

David Crean, chief business officer at MedicNova, highlights bifurcation in regulatory processes at FDA.

In today's Pharmaceutical Executive Daily, Eli Lilly announces a deal worth up to $202 million for Engage Biologics and its preclinical non-viral DNA delivery platform, two significant deals including Bristol Myers Squibb's enterprise-wide agreement to deploy Claude across its global operations and Incyte's expanded molecular AI collaboration with Genesis, and FDA grants two new early-stage breast cancer indications to Enhertu, marking trastuzumab deruxtecan's entry into the curative-intent setting for the first time.

Toragen CEO Sandra Coufal, MD, discusses why the company is targeting HPV’s overlooked E5 protein, positioning its small-molecule therapy as a potential complement to checkpoint inhibitors like Keytruda across HPV-driven cancers.

Bristol Myers Squibb and Incyte expand AI capabilities through major collaborations aimed at embedding agentic and molecular AI directly into drug discovery, development, and enterprise operations.

Sandra Coufal, MD, CEO of Toragen, says the company is positioning its HPV E5 inhibitor TGN-S15 not as a competitor to Merck’s Keytruda, but as a combination partner designed to enhance checkpoint inhibition.

MedicNova’s chief business officer David Crean explains how well-intentioned but poorly executed programs at FDA are causing tension between the agency and the industry.