Drugs

Berg Pancreatic Cancer Therapy Granted Orphan Designation

FDA has granted Berg an orphan drug designation for its leading product candidate BPM31510, indicated for treating pancreatic cancer. The company says it is planning a precision medicine-driven Phase 2 clinical trial for BPM31510-IV alone and in combination with gemcitabine to evaluate the efficacy in patients with advanced pancreatic cancer in the U.S. and Europe. “As part of this Phase 2 trial, the company is driving towards identification and validation of molecular profiles representative of BPM31510 mediated outcomes, which could lead to a diagnostic panel for patient stratification,” it says.

BPM31510 is a first-in-class molecule that specifically targets the dysregulated metabolism observed in cancer. “BPM31510, by targeting metabolism in cancer cells, re-engages the mitochondria to generate energy, shifting metabolism to that observed in the normal cell,” Berg says. “The effect of BPM31510 on metabolism results in the reactivation of pathways that detect cell damage, triggering apoptosis or programmed cell death.”

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