Karnataka fake drug case: Pfizer issues statement after FDA revokes licenses of 16 pharmacies

The FDA is scrutinizing REGENXBIO's RGX-202 and Solid Biosciences' SGT-003, both Duchenne muscular dystrophy treatments, for accelerated approval. The FDA requires evidence that microdystrophin expression predicts clinical benefit, citing Pfizer's failed CIFFREO trial as a cautionary example. REGENXBIO reported 93% of patients reached 10% microdystrophin expression, but functional data is limited. The FDA seeks robust evidence before approval, given the permanent nature of gene therapy.

The weight-loss drug market is growing rapidly, with analysts projecting $100B in annual sales in the next decade. Novo Nordisk and Eli Lilly lead the sector, but other companies like Pfizer, Viking Therapeutics, and AstraZeneca are developing new treatments. Key drugs include Novo's amycretin and CagriSema, Pfizer's PF-3944, and Lilly's retatrutide, with varying degrees of success in clinical trials.

Public Citizen disclosed 'Most Favored Nation' drug pricing agreements between the U.S. government and Pfizer (PFE), Eli Lilly (LLY), and Novo Nordisk (NVO), warning of potential global price impacts. The nonprofit raised concerns about ambiguous provisions and missing details in the deals, questioning Trump's drug policy achievements. Pfizer and Lilly shares were down in premarket trading, according to Benzinga Pro.

Studies show RSV vaccines from GlaxoSmithKline and Pfizer are highly effective in older adults, mirroring clinical trial results. The vaccines performed similarly, and their efficacy remained high even after adjusting for healthcare access. Researchers are now studying the need for booster shots.

Pfizer (PFE) is conducting a phase 3 trial to test rimegepant for chronic migraine prevention. The study aims to reduce monthly migraine days and improve daily functioning. Rimegepant is already approved for acute and episodic migraine. A successful trial could expand Pfizer's neurology revenue and impact competitors. The trial is ongoing, with updates posted on ClinicalTrials.

Pfizer (PFE) completed a Phase 1 study for PF-07799544, an experimental oral drug. The study, focused on drug movement and clearance in healthy men, was completed on 2026-09-18. This milestone clears a key safety and dosing step before larger trials, supporting Pfizer's long-term pipeline.