Drugs

FDA Fast Track Designation for Senhwa’s Silmitasertib

FDA has granted fast track designation for Senhwa Biosciences’ silmitasertib for treating patients with recurrent sonic hedgehog (SHH) driven medulloblastoma. The company says the designation makes it eligible to apply for accelerated approval and priority review when it meets relevant FDA criteria.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium, is conducting a Phase 1/2 and surgical study of silmitasertib in both children and adults with recurrent SSH medulloblastoma at several academic medical centers and children’s hospitals across the U.S.

Medulloblastoma is the most common cancerous brain tumor in children and no targeted therapy is available. Silmitasertib was granted rare pediatric disease designation by FDA 7/6/20. It is described as a first-in-class small molecule drug that targets the CK2 (casein kinase 2) pathway and acts as a CK2 inhibitor. It is being studied as a Covid-19 treatment and in several oncology programs, Senhwa says.

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