Drugs

Context Therapeutics’ Ovarian Cancer Drug Wins Fast Track

FDA has granted Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer, a difficult-to-treat form of the disease with limited options. CTIM-76 is described as a T cell–engaging bispecific antibody designed to target CLDN6-positive tumors by binding both cancer cells and T cells, potentially directing the immune system to attack malignancies. The therapy is being developed for patients whose ovarian cancer has progressed despite standard treatments.

The company said the drug is currently being evaluated in an ongoing Phase 1 clinical trial studying its safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity. The trial includes patients with advanced or metastatic ovarian, endometrial, and testicular cancers expressing the CLDN6 protein.

Context expects to report interim data from the early-stage study in June, which could provide initial insight into the therapy’s clinical activity.

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