Drugs

Mural Oncology Scraps Nemvaleukin Alfa

Mural Oncology says it is discontinuing all clinical development of its lead drug candidate, nemvaleukin alfa, following disappointing results from two key trials in melanoma and ovarian cancer. The company also said it will begin exploring strategic alternatives to “maximize shareholder value.”

The action follows a review of topline data from the phase 2 ARTISTRY-6 trial and previously announced interim results from the phase 3 ARTISTRY-7 trial. The ARTISTRY-6 study, which evaluated nemvaleukin as a monotherapy in patients with mucosal melanoma, failed to meet its primary endpoint, according to the company. Additionally, it notes a lack of sufficient clinical activity in another cohort of the same study that evaluated a less frequent dosing regimen in patients with cutaneous melanoma.

Previously, Mural disclosed interim overall survival data from the ARTISTRY-7 trial in platinum-resistant ovarian cancer which showed that nemvaleukin in combination with pembrolizumab did not achieve a statistically significant improvement in overall survival versus investigator’s choice chemotherapy alone.

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