North America

SHERIDAN, WYOMING - November 13, 2025 - Major pharmaceutical companies are rapidly rolling out direct-to-consumer (DTC) pricing programs ahead of the federal TrumpRx platform's debut in early 2026, signaling a shift in commercial strategy as manufacturers seek to bypass traditional intermediaries and regain control of how patients access branded therapies. Yet analysts warn that these channels-despite deep headline discounts-may offer only marginal financial relief to most patients and are unlikely to dent overall U.S. drug spending.

SHERIDAN, WYOMING - November 13, 2025 - As the federal government prepares to launch its TrumpRx direct-to-consumer platform in early 2026, U.S. drugmakers are accelerating their own discount initiatives in anticipation of sweeping pricing reforms tied to the Most Favored Nation (MFN) framework. Yet analysts and health economists warn that these programs-ranging from discounted dermatology creams to multi-billion-dollar GLP-1 therapies-may have limited influence on overall spending, with most insured patients unlikely to shift away from existing payer pathways.

SHERIDAN, WYOMING - November 13, 2025 - Drug manufacturers are urging the FDA to broaden its proposed PreCheck program beyond new factory construction, warning that excluding existing facilities could slow U.S. efforts to expand pharmaceutical production capacity. At a recent agency meeting, representatives from companies spanning gene therapy, generics, and biologics argued that PreCheck's current scope overlooks the fastest route to alleviating drug shortages and strengthening domestic supply chains.

Early-Stage Regulatory Support Designed Only for New Sites
PreCheck was introduced to streamline the regulatory oversight of newly built manufacturing plants, giving participating companies earlier FDA engagement well before their first commercial product application. The program is meant to make U.S. construction more attractive by reducing uncertainty and aligning expectations early in the buildout process.

SHERIDAN, WYOMING - November 13, 2025 - In a sweeping regulatory shift with major implications for women's health providers, pharmaceutical manufacturers, and payers, the FDA has removed the black box warning from all hormone replacement therapy (HRT) products. The reversal ends a 22-year stance shaped by the early 2000s Women's Health Initiative (WHI) trial and opens the door to renewed clinical adoption and investment across the growing HRT market.

SHERIDAN, WYOMING - November 13, 2025 - Amgen has introduced a new U.S. direct-to-patient model that aims to make Repatha more affordable and accessible to adults at elevated cardiovascular risk. The initiative, called AmgenNow, offers a nearly 60% price reduction and removes common payer-driven barriers-an unusual move in the cardiometabolic market and one that could ripple across manufacturers, payers, and care-delivery partners seeking more predictable access pathways.