Drugs

Lilly Cancer Drug Misses Endpoint

Eli Lilly says top-line results from the Phase 3 SEQUOIA trial evaluating its pegilodecakin plus Folfox (folinic acid, 5-FU, oxaliplatin) show that pegilodecakin failed to meet its primary endpoint of overall survival in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing regimen.

The company describes pegilodecakin as an immunotherapy that stimulates the body’s natural defenses against cancer and expands tumor-attacking T cells.

Lilly Oncology vice president Maura Dickler said that while the company is disappointed in the SEQUOIA outcome, it looks forward to upcoming results in lung cancer, learning from those results, and increasing the understanding of pegilodecakin’s novel mechanism of action in cancer immunotherapy.

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