Drugs

HutchMed NDA for Pancreatic Tumor Therapy

HutchMed has completed a rolling NDA submission for surufatinib for treating pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs). The NDA is supported by data from two Phase 3 studies of surufatinib in NET conducted in China (SANET-p¹ and SANET-ep²), and by data from a surufatinib study conducted in the U.S. in patients with pancreatic and extra-pancreatic NET.

NETs form in cells that interact with the nervous system or in glands that produce hormones, according to the company. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant.

HutchMed describes surufatinib as a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors and fibroblast growth factor receptor, which both inhibit angiogenesis, according to the company. It is also designed to inhibit colony stimulating factor-1 receptor, which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. “Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects,” it 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