New biologic for severe asthma doesn't stack up well to standard of care on generally accepted levels of cost per quality-adjusted life year.
GlaxoSmithKline PLC's severe asthma treatment Nucala will need to be significantly discounted to make it cost-effective, according to a draft report on the product's value by the Institute for Clinical and Economic Review released Dec. 21.
Nucala (mepolizumab), a physician-administered biologic approved Nov. 4, is priced at a wholesale acquisition cost (WAC) of $32,500 per year...
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
