Drugs

Mesoblast Gets Fast Track for Remestemcel-L

FDA has granted Mesoblast Ltd. a Fast Track designation for remestemcel-L for treating acute respiratory distress syndrome (ARDS) due to Covid-19 infection. The designation is based on clinical data from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mount Sinai Hospital earlier this year. In the study, nine of 12 ventilator-dependent patients (75%) with moderate to severe Covid-19 ARDS were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L, the company says.

An ongoing randomized controlled Phase 3 trial in up to 300 ventilator-dependent patients is about two-thirds enrolled, Mesoblast says. The trial’s primary endpoint is overall mortality at Day 30, and the key secondary endpoint is days alive off ventilatory support through Day 60, it says.

Mesoblast recently entered into a license and collaboration agreement with Novartis to develop, manufacture and commercialize remestemcel-L.

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