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 (RCC) or...

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 FDA...

Chronic obstructive pulmonary disease (COPD) affects many people globally, causing distress to patients and families and burdening healthcare systems. It is a challenging disease to manage. According to studies, COPD hospitalizes approximately 700,000 individuals in...

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...

You saw it in the news this winter - the country experienced a tripledemic of the flu, respiratory syncytial virus (RSV) and Covid-19. According to The Hill, 40% of US households have had someone infected with at least one of these respiratory viruses, experiencing...