Sanofi’s experimental multiple sclerosis drug tolebrutinib has encountered two major setbacks: a delayed regulatory decision in the U.S. and a failed late-stage clinical trial. The French drugmaker said the FDA’s decision on tolebrutinib for treating an advanced form of multiple…
Pharmacy
Ten medications accounted for nearly one-third of 340B program-covered outpatient drugs in 2024, according to a Dec. 11 report. The Health Resources and Services Administration, an HHS agency, reported that 340B covered entities purchased $81.4 billion in outpatient drugs through…
Pharmacy leaders say 2026 is shaping up to be a year defined by financial volatility, regulatory pressure and workforce strain — all intensified by upcoming federal drug pricing reforms. Across organizations, the challenges are stacked. Drug pricing reforms are reshaping…
Rising uncompensated care, escalating cybersecurity and climate risks, and major shifts in the 340B and pharmacy benefit manager landscapes are prompting health systems to rethink how they deliver and finance care, according to the American Society of Health-System Pharmacists’ forecast…
Ahead of HHS’ planned 340B rebate pilot program, several healthcare organizations urged congressional leaders to cancel the pilot they say would threaten care access for low-income and rural patients. The pilot program, slated to launch Jan. 1, will allow drug…
The FDA is considering adding a black box warning to COVID-19 vaccines — the latest development in a broader shift in how the agency approaches vaccine oversight and safety communication, according to a Dec. 12 CNN report. Here are seven…
Middlesex (Conn.) Hospital has opened its first specialty pharmacy — a move President and CEO Vincent Capece Jr. said will improve care coordination, increase visibility into whether patients receive high-cost medications, and help the system better support those struggling to…
The Board of Pharmacy Specialties formally recognized pharmacy informatics as a specialty certification Dec. 8. The certification agency said it will release more information on its 16th certified pharmacy specialty “at a later date.” The announcement comes two weeks after…
In a phase 3 trial, Eli Lilly’s experimental drug retatrutide delivered an average 28.7% weight loss and reduced pain among adults with obesity or overweight and knee osteoarthritis. The trial recruited 445 participants and divided them equally to receive retatrutide…
An FDA advisory panel has recommended easing restrictions on testosterone replacement therapy, including removing the hormone’s designation as a controlled substance and expanding eligibility for treatment. During a public meeting Dec. 10, the 13-member panel consisting of urologists and federal…