Drugs

Vivace Mesothelioma Drug Gets Orphan Status

FDA has granted Vivace Therapeutics an orphan drug designation for VT3989 and its use in treating mesothelioma. The company describes the drug as a first-in-class inhibitor targeting the Hippo signaling pathway, a key regulator of cell growth and organ size. Specifically, the drug is designed to block autopalmitoylation of TEAD proteins, a mechanism believed to be central to certain cancers, it says.

To date, VT3989 has been tested in more than 200 patients in an ongoing open-label Phase 1 trial evaluating the drug’s safety, pharmacokinetics, and biological activity in patients with advanced solid tumors, including pleural and non-pleural mesothelioma. According to Vivace, the drug has shown early signs of clinical efficacy and a favorable safety profile — particularly in patients whose disease progressed after chemotherapy and immunotherapy, the current standard treatments.

Full trial results are expected to be presented at a major medical conference later this year. The company says it plans to begin a Phase 3 study by the end of the year.

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