CER Daily Newsfeed

JAK Inhibitors for Atopic Dermatitis Increase the Risk for Serious Infections

(3/27, Jessica Nye, PhD, Clinical Advisor) reports “Patients with atopic dermatitis (AD) who were treated with Janus kinase (JAK) inhibitors had an increased risk for serious infection compared with those who received Th2 cytokine inhibitors, according to study results presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting...” Full

Expanding the Use of Real-World Evidence Can Make FDA Regulatory Decisions Faster, Cheaper, and Just as Safe

(3/27, Randall Lutter, Manhattan Institute) comments “...FDA should increase the use of RWE in drug regulation by increasing transparency into its use of RWE, supporting more research into the reliability of RWE, and committing to specific quantitative goals. Specifically, one-half of all supplemental applications for new uses of drugs should incorporate RWE by 2030. Also, there should be increased use of RWE in novel rare disease treatments. If FDA fails to adopt these goals, Congress should require them.” Full

Think Tank Suggests CMS, USTR Could Enforce Most Favored Nation, Other Drug Pricing Policies

(3/26, Cathy Kelly, Pink Sheet) reports “...Variations of the Most Favored Nation and International Pricing Index models developed in the first Trump Administration could be resurrected to address 'global freeloading' of US R&D efforts, the America First Policy Institute suggested. The issue brief also proposed applying tariffs and other trade levers to raise the prices foreign governments pay for drugs to increase their contribution to R&D efforts. The Trump Administration is expected to return to policies related to international reference pricing, but biopharma wants to ensure they focus on raising prices abroad and not just lowering them in the US.” Subscription Required

Targeting FDA User Fees Would Leave Agency Gutted, Experts Say

(3/27, Lia DeGroot, Roll Call) reports “...[Mark McClellan, the director of the Duke-Margolis Institute for Health Policy] said if user fees were eliminated, there would need to be additional appropriated funds for the FDA to fully operate, which he said would be challenging for Congress to agree to. He underscored that losing that funding would result in slower approval times and less clear approval decisions that would ultimately result in poor outcomes for health.” Full

German Ordinance To Implement HTA Reg Leaves Room For Doubt

(3/27, Francesca Bruce, Pink Sheet) reports “...The German legislator’s approach to implementing the EU Health Technology Assessment (HTA) Regulation and incorporating EU joint clinical assessment (JCA) reports into the national pricing and reimbursement system is ‘hesitant and vague,’ according to Germany-based lawyers from the law firm Hogan Lovells.” Subscription Required