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.
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.
