FDA Flags Misleading Claims in Drug Ads from Novo, argenx and Sobi
Summary:
The FDA issued untitled letters to Novo Nordisk, argenx and Sobi, citing false or misleading claims in direct-to-consumer ads, including suggestions of superior efficacy, oversimplified treatment administration and omitted risk information. The agency raised concerns about unsupported benefits, unclear indications and distracting visuals, giving each company 15 days to respond.
White House Launches TrumpRx Portal With Limited Impact on Drug Costs
Summary:
The Trump administration has launched TrumpRx, an online portal offering about 40 discounted drugs from manufacturers like Pfizer, Eli Lilly and Novo Nordisk under “most favored nation” pricing agreements. While the platform may lower costs for cash-paying patients, it is expected to have minimal impact on most Americans whose medications are covered by insurance, and critics argue the discounts offer limited savings compared to existing coverage options.
Evommune Jumps After Mid-Stage Dermatitis Data Challenges Dupixent
Summary:
Evommune’s shares surged 75% after its IL-18–targeting protein EVO301 showed a 33% placebo-adjusted reduction in atopic dermatitis severity in a Phase 2a trial, results comparable to Regeneron and Sanofi’s blockbuster Dupixent. Analysts called the data highly encouraging, noting potential for greater efficacy with optimized dosing as Evommune prepares a Phase 2b study and expands development into other inflammatory diseases.
Japan Election Clears Way for Increased Research Funding
Summary:
A landslide victory by Prime Minister Sanae Takaichi’s Liberal Democratic Party has strengthened her ability to pursue a technology-led growth strategy, including higher government spending on R&D in areas such as AI, semiconductors and biotechnology. While early budget plans point to modest increases for basic research, grants and university support, scientists say the long-term impact will depend on whether political commitments translate into sustained funding and structural reform.
FDA Rejects Moderna’s mRNA Flu Shot Filing, Sparking Public Dispute
Summary:
The FDA issued Moderna a refusal-to-file letter for its mRNA flu vaccine mRNA-1010, citing concerns that the Phase 3 trial’s control arm did not represent the “best-available standard of care,” despite using an FDA-approved comparator. Moderna sharply criticized the decision as inconsistent with prior FDA guidance and broader regulatory standards, publishing the letter and seeking talks with the agency while continuing reviews in the EU, Canada and Australia.
