Drugs

Corcept’s Relacorilant Shows Promise in Ovarian Cancer

Corcept Therapeutics is announcing promising results from its pivotal Phase 3 ROSELLA trial, demonstrating that relacorilant in combination with nab-paclitaxel significantly improves progression-free survival (PFS) in patients with platinum-resistant ovarian cancer. In meeting the trial’s primary endpoint, relacorilant was shown to reduce the risk of disease progression by 30% compared to nab-paclitaxel alone, the company says, adding that patients receiving the combination therapy had a median PFS of 6.5 months, compared to 5.5 months for those on chemotherapy alone, it adds.

“The improvement in survival without added safety burden brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” Corcept says. The company says it will submit an NDA in the third quarter.

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