Drugs

SN Bioscience Gets Fast Track for Lung Cancer

FDA has granted SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer (SCLC). The drug was previously granted orphan drug status for SCLC and pancreatic cancer 7/23 and February of this year, respectively.

The company says the drug, an active metabolite of Irinotecan, has been designed as “extremely insoluble” polymer nanoparticles. Preclinical and Phase 1 clinical data “showed that it significantly reduced digestive system adverse events (nausea, vomiting, diarrhea, etc.) compared to existing anticancer drugs,” it says, adding that it “showed excellent efficacy” in lung cancer patients through lung targeting. Phase 2 global clinical trials are scheduled to begin after IND approval in the US and Europe in the second half of this year, SN Bio 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