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Kevin Dondarskit of Deloitte Consulting discusses the risks that drug makers face if they decide to put too much focus on an area where they may lack expertise, such as the emerging GLP-1 market.

In today’s Pharmaceutical Executive Daily, the FDA approves Datroway for certain patients with metastatic triple-negative breast cancer, leadership changes continue at the National Institutes of Health with the departure of a top infectious disease institute director, and industry experts discuss how real-time data is reshaping biotech decision-making and development strategy.

FDA approves AstraZeneca and Daiichi Sankyo’s Datroway for first-line metastatic triple-negative breast cancer, expanding treatment options for patients ineligible for PD-1/PD-L1 inhibitor therapy.

Jeffrey Taubenberger’s departure was announced by Senator Baldwin during a congressional hearing.

MedicNova’s chief business officer details how changes at FDA are causing tension with the industry and investors, who are finding themselves less confident in the regulatory process.

Kevin Dondarskit of Deloitte Consulting discusses how pharma companies are focusing on high-value assets that serve large patient populations.

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.

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.