Pharma Pulse 5/21/25: The Road to Simpler and Better Clinical Trials; FDA Outlines Stricter Covid Vaccine Booster Standards for Healthy People
Less is More in Clinical Data: The Road to Simpler and Better Trials
In an article for Applied Clinical Trials, Drew Garty, chief technology officer, Veeva, emphasizes that simplifying clinical trial data management through pragmatic strategies—like endpoint-driven design, risk-based approaches, and smart automation—can reduce waste, improve site and patient experiences, and lay the groundwork for future innovations like AI.
FDA outlines stricter Covid vaccine booster approval standards for healthy people
In a new policy outlined in The New England Journal of Medicine, the FDA—under Commissioner Marty Makary and vaccine division head Vinay Prasad—announced stricter approval standards for future COVID-19 boosters in healthy individuals, requiring randomized, placebo-controlled clinical trials to demonstrate real-world benefit.
Predicting GLP-1 Side Effects: Q&A with Andres Acosta, MD, PhD
In an interview with Pharmaceutical Executive, Andres Acosta, MD, PhD, emphasized that GLP-1s aren’t suitable for all patients due to adverse effects and variable efficacy, and highlighted how phenotype-based treatment and predictive tools like genetic risk scoring are advancing precision obesity care.
HHS, CMS Set Most-Favored-Nation Pricing Targets to End Global Freeloading on American Patients
In a new move announced by HHS, CMS, and the Trump Administration, US health officials set most-favored-nation pricing targets to require drugmakers to match US brand-name drug prices to the lowest among comparable OECD countries, aiming to reduce costs for American patients.
Countries formally adopt WHO’s Pandemic Agreement for future pandemics
At the 78th World Health Assembly in Geneva, 124 countries formally adopted the WHO’s first Pandemic Agreement—an international framework to strengthen global preparedness and ensure equitable access to health tools during future pandemics—though concerns remain over funding, national sovereignty, and intellectual property protections.
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.
