Unpacking the FDA Advisory Committee Meeting for Merck’s Gefapixant
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 unexplained chronic cough (UCC). As there is currently no FDA-approved treatment for chronic cough, the result was […]
Beyond Cough Count: Why It’s Time to Go Deeper in Cough Trials
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 are other measurements often overlooked that can provide much greater insight into the true burden of the patient’s […]
Navigating the FDA Digital Health Technology Guidance: Insights for Respiratory Drug Developers
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 continues to signal its endorsement of collecting objective data in daily life (e.g. cough and wheeze […]
COPD Remote Patient Monitoring: Overview & New Technologies
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 the United States annually. Data also shows that these individuals have a readmission rate of over 20% within 30 days. Advancements in […]
Cough and Wheeze Endpoint Measurement: Objective or Subjective?
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 possible to measure these symptoms while patients are at home, allowing for objective 24-hour monitoring and […]
How Monitoring Lung Sounds Could Reduce Hospital Visits in Future ‘Tripledemic’ Winters
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 symptoms including body aches, fever, coughing, shortness of breath, sneezing, and/or wheezing. […]
Takeaways from JP Morgan Week 2023
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 highlights my key takeaways from the conference which I hope will be helpful to clinical […]