Postmarket research
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.
Longitudinal studies that track patients’ experiences can inform and accelerate the drug approval process for rare diseases.
The joint venture between Walgreens and Prothena to accelerate the approval of an Alzheimer’s treatment is the latest in biotech and retail chain alliances.
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