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)…
Sponsors of new oncology drugs and biologics that aim to apply for Accelerated Approval (AA) should use a randomized controlled trial (RCT) design rather than a single-arm trial in most…
The FDA has told Incyte that it can’t review the company’s new drug application (NDA) for Janus kinase inhibitor Jakafi (ruxolitinib) extended-release (XR) tablets without more supporting data. Source: Drug…
The International Council for Harmonization (ICH) has finalized a new guideline covering nonclinical considerations for gene therapies, setting the stage for individual ICH member nations to accept and release their…
The Biden administration’s fiscal 2024 budget request dedicates a total of $59 million for new efforts to increase drug and device supply chain security, HHS Secretary Xavier Becerra told Congress…
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…
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…
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. Source:…
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day…
The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical…