Drugs

Biofourmis Platform in CERSI Heart Study

An FDA Center of Excellence in Regulatory Science and Innovation (CERSI) research study conducted with Yale University and the Mayo Clinic will use the Biofourmis BiovitalsHF mobile platform, starting with a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis should be placed on them in the drug approval process. Biofourmis says that currently, endpoints such as mortality and hospitalizations remain the gold standard in efficacy and efficiency trials for FDA approval and clearance of heart failure therapies. However, the company says, patients with heart failure also experience a significant drop in functional capacity and quality of life, which currently are not viewed as clinical trial endpoints.

To demonstrate the feasibility and reliability of capturing the patient-centric endpoints, Biofourmis and the Yale/Mayo CERSI will conduct a multi-center study of recently discharged heart failure patients starting in August. The patients will be screened and then monitored at home for 60 days. In the study, BiovitalsHF reportedly will be used to capture multiple physiology biomarkers and physical activity continuously in real-world settings, using two wearable biosensors.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome