We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
GOTHENBURG, SWEDEN — The FDA correctly approved Biogen’s Aduhelm (aducanumab) in 2021 because the drug met the criteria for disease modification the agency had laid down for Alzheimer’s disease (AD) drug sponsors years before, according to a former FDA employee. Read More
The European Medicines Agency (EMA) reported “remarkable” progress despite the pandemic in a mid-point assessment of its “Regulatory Science Strategy to 2025” to build a more adaptive regulatory system that will encourage innovation — including advances in clinical trials and a new real-world data (RWD) network. Read More
The FDA announced yesterday that its generic drug program has resumed in-person, face-to-face meetings with industry, in a phased-in approach alongside videoconference meetings. Read More
Roche has teamed up with Eli Lilly to develop Roche’s Elecsys Amyloid Plasma Panel (EAPP), an investigational blood-based biomarker test designed to give patients an earlier Alzheimer’s disease diagnosis. Read More
A California judge has ruled that a lawsuit by one individual against GlaxoSmithKline (GSK) for its heartburn drug, Zantac (ranitidine), may go ahead — potentially setting the stage for other Zantac consumers in the state to have their day in court. Read More
The pandemic has exposed longstanding vulnerabilities in the U.S. medical supply chain as well an overreliance on China and other countries, according to a new report on drug shortages by the majority staff on the Senate Committee on Homeland Security and Governmental Affairs. Read More
Private group or individual health plans would be required to cover one of each insulin dosage form (a vial or pen) and insulin type (rapid-acting, short-acting, intermediate-acting and long-acting) for no more than $35 per month. Read More