Drugs

FDA Partial Hold on Mersana Trials

FDA has issued a partial clinical hold against Mersana Therapeutics’ clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensitive ovarian cancer after the company submitted a safety report that evaluated bleeding events. The hold affects the UP-NEXT and UPGRADE-A clinical trials, and patients who are already enrolled may continue receiving UpRi, according to the company.

“Although data on the background rate of bleeding in platinum-resistant ovarian cancer are limited, Mersana’s recent assessment determined that serious bleeding events appear to occur at a higher rate than background,” the company says. “While most bleeding cases in this aggregate safety analysis were low-grade, five (less than 1%) Grade 5 (fatal) bleeding events were observed among the approximately 560 patients dosed to date. The causes of bleeding events remain under investigation.” Additionally, Mersana says UPLIFT top-line data will be available shortly, which will provide a more complete assessment of both the efficacy and safety profile for UpRi in platinum-resistant ovarian cancer.

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