As reported by BioPharmaDive, he Food and Drug Administration (FDA) has intensified its oversight of companies marketing compounded GLP‑1 therapies, while Intellia Therapeutics, United Therapeutics, Merck & Co., and federal health officials all delivered notable developments across the biopharmaceutical landscape this week.
FDA Sends Second Wave of Warning Letters Over GLP‑1 Claims
The FDA issued 30 new warning letters to telehealth vendors promoting compounded GLP‑1 products with unfounded assertions that they match FDA‑approved drugs. Regulators cited “false or misleading” statements and the lack of clarity about where the products originate.
This latest enforcement action follows a similar series of letters sent in September and reflects broader efforts to clamp down on aggressive pharmaceutical advertising and unauthorized GLP‑1 imitators—issues highlighted after Hims & Hers briefly explored offering a compounded version of Novo Nordisk’s Wegovy pill.
Intellia Cleared to Resume Late‑Stage Gene Editing Trial
Intellia Therapeutics has received FDA authorization to restart a Phase 3 trial evaluating its CRISPR‑based therapy for transthyretin amyloidosis with cardiomyopathy, a progressive and potentially fatal cardiac condition.
The study had been paused—along with another late‑stage Intellia trial—following the death of a participant last year. Both programs may now proceed under updated safety measures, including excluding patients with recent cardiac complications. Company shares initially rose more than 10% following the announcement before leveling off.
Ralinepag Shows Strong Phase 3 Benefit in Pulmonary Arterial Hypertension
United Therapeutics reported that its investigational therapy ralinepag reduced the risk of disease progression by 55% compared with placebo in a pivotal Phase 3 trial of patients with pulmonary arterial hypertension (PAH).
Ralinepag, a next‑generation prostacyclin receptor agonist, aims to improve blood vessel dilation in individuals with PAH. Analysts at Leerink Partners noted that the results surpassed expectations and compared favorably with outcomes from Johnson & Johnson’s Uptravi. United licensed ralinepag from Arena Pharmaceuticals in 2018 and intends to seek regulatory approval later this year.
HHS Adds Two Clinicians to Vaccine Policy Panel
Health and Human Services Secretary Robert F. Kennedy Jr. appointed two physicians—Sean Downing, a Florida‑based primary care doctor, and Angelina Farrella, a Texas pediatrician—to the Advisory Committee on Immunization Practices (ACIP).
The committee has undergone significant changes over the past year and has revised several long‑standing vaccine recommendations, prompting concern from major medical organizations and legal challenges from multiple states. ACIP’s next meeting is set for March 18.
Merck Advances Kidney Cancer Strategy With New Welireg Data
Merck & Co. released detailed findings from two studies evaluating expanded uses of its hypoxia‑inducible factor inhibitor Welireg in renal cell carcinoma.
In one trial, combining Welireg with Keytruda after tumor‑removal surgery reduced the risk of disease progression or death by 28% compared with Keytruda alone. A second study found that pairing Welireg with Eisai’s Lenvima lowered that risk by 30% versus treatment with Exelixis’ Cabometyx in patients whose cancer returned after Keytruda therapy.
Analysts at Leerink said the results position Welireg‑based regimens to become new standards of care. The firm now projects more than $3.4 billion in U.S. peak sales for the drug, which Merck obtained through a 2019 acquisition.
