In November 2023, Merck’s chronic cough drug, gefapixant, faced a decisive setback from the FDA Advisory Committee. The concerns highlighted insufficient evidence for the drug providing a clinically meaningful benefit to adults with refractory chronic cough...
24-hour cough frequency has traditionally been recognized as the ‘gold standard’ primary endpoint for indications such as refractory chronic cough, chronic bronchitis, and IPF-related cough. While frequency is undoubtedly a valuable metric to measure for cough, there...
In December 2023, the FDA published its final release of “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” a pivotal step in formalizing regulatory standards and guidance for remote data collection in clinical trials. As the...
Changes in symptoms such as coughing and/or wheezing are highly important endpoints in clinical trials focused on COPD, Asthma, IPF, Cystic Fibrosis, and other indications. With the growing availability of digital health technologies (DHTs) and wearables, it is now...
I returned from the exciting JP Morgan 41st Annual Healthcare Conference last week in San Francisco and greatly enjoyed learning from the speakers and leaders in the pharmaceutical industry on the latest trends and thinking. I put together this short blog that...
