Drugs

AbbVie's Venetoclax Fails to Improve Survival in Trial

AbbVie says its Phase 3 VERONA clinical trial evaluating venetoclax in combination with azacitidine for newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS) did not meet the primary endpoint of extending overall survival. The trial showed a hazard ratio of 0.908 and a p-value of 0.3772, indicating no statistically significant improvement in survival compared to treatment with azacitidine alone, the company it says, adding that no new safety concerns were reported.

AbbVie says the results, which will be presented at an upcoming medical conference or published in a peer-reviewed journal, do not affect any currently approved uses of venetoclax. Patients who were enrolled in the trial will be informed of the outcome by their physicians, according to AbbVie.

Venetoclax, marketed as Venclexta in the U.S., is described as a first-in-class BCL-2 inhibitor developed by AbbVie and Roche. It is currently approved for various blood cancers, including chronic lymphocytic leukemia and acute myeloid leukemia.

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