Pharma Pulse 5/8/2025: J&J Survey Finds Pace of Oncology Innovation is Overwhelming Physicians, Biotech is Guessing How Vinay Prasad Might Change the FDA

J&J survey finds pace of oncology innovation is overwhelming physicians

A recent J&J survey reveals that oncologists are overwhelmed by the rapid pace of oncology innovation, highlighting the need for additional support and continuing medical education to help them keep up with new treatments and guidelines.

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues

Vinay Prasad, named head of the FDA’s Center for Biologics Evaluation and Research, is expected to bring a more stringent, evidence-based approach to drug approvals, especially for cancer, gene therapies, and biologics, based on his critical views on the use of surrogate endpoints, cost-effectiveness, and the effectiveness of non-curative treatments.

FDA ends advance notice for foreign drugmaker inspections: 5 notes

The FDA is ending advance notice for inspections of foreign drug manufacturing sites to ensure more rigorous oversight and level the playing field with domestic producers, following a history of higher deficiency rates in foreign facilities.

Creating a Gray Zone in Payer Messaging: Outflanking Comparability

An article from Pharmaceutical Executive discusses how second-to-market pharmaceutical companies can create a "gray zone" in payer messaging by highlighting unique clinical strengths, such as improved tolerability, dosing, or trial design, to secure better access despite potential challenges with cost or efficacy comparisons to incumbents.

FDA set to meet this month on COVID vaccines

The FDA is set to meet on May 22 to discuss updating COVID-19 vaccine formulas for the fall and winter season, with a new director leading the agency and heightened scrutiny around booster recommendations and approval processes.