Postmarket research
In the largest study of its kind, GSK’s two-drug regimen Dovato demonstrated non-inferior efficacy compared to Gilead Sciences’ three-drug regimen Biktarvy for the treatment of HIV-1.
Health economics and outcomes research (HEOR) is a critical but sometimes overlooked part of drug development. Decentralized trials now make it easy.
With over 20% of people born between 1997 and 2003 identifying as a sexual and gender minority, moderated panels at SCOPE 2024 discuss the need to engage this community in clinical trials.
While the FDA continues to investigate reported cases of T cell malignancies in patients who received CAR-T therapies, the cause of the secondary cancers remains unclear.
A failed rare disease clinical trial brings social media expertise to the pharma industry and patient recruitment: A discussion with Bryan Manning, founder of Clinical Enrollment and Two Blind Brothers
High multiplexed patient-centric assays could reduce patient burden
Protocol design optimization and timely engagement of regulators are the crux of optimized, patient-centric clinical trials.
The program—a joint initiative between CDER and CBER—aims to accelerate the development of therapies for rare diseases.
The European Medicines Agency recently flagged a safety signal related to GLP-1 receptor agonists and sent a list of questions to manufacturers including Novo Nordisk, Eli Lilly, Sanofi and AstraZeneca.
In the first head-to-head trial of CGRP antagonists, Lilly’s Emgality failed to demonstrate that it was significantly better than Pfizer’s Nurtec ODT at easing migraine headaches.
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