Drugs

Pitts Named to BrainStorm Cell Therapeutics Board

Former FDA associate commissioner Peter Pitts, who is now president of the Center for Medicine in the Public Interest, has been named to the BrainStorm Cell Therapeutics board of directors. A company announcement says that once it obtains funding, BrainStorm will start its Phase 3b ENDURANCE trial evaluating NurOwn for ALS (amyotrophic lateral sclerosis). The statement says the NurOwn platform uses autologous mesenchymal stem cells to produce neurotrophic factor-secreting cells designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. The platform has received an orphan drug designation from FDA.

Pitts said that BrainStorm “is conducting some of the most important and scientifically rigorous work in neurodegenerative medicine today. FDA’s special protocol assessment for the Phase 3b trial is unprecedented in ALS and sends a powerful signal that the agency recognizes both the seriousness of the disease and the strength of the trial design. Just as importantly, FDA is now under new management, and we believe that creates a far greater opportunity for smart regulatory innovation, serious scientific engagement, and patient-focused flexibility than we’ve seen in recent years. Patients with terminal ALS do not have the luxury of bureaucratic drift or ideological grandstanding. They need urgency, rigor, and leadership.”

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