Drugs

Actuate Gets Orphan Status for Pancreatic Cancer

FDA has granted Actuate Therapeutics an orphan drug designation for elraglusib for treating patients with pancreatic cancer. Elraglusib is described as a glycogen synthase kinase-3 beta (GSK-3β) inhibitor that targets molecular pathways in cancer that are involved in promoting tumor growth and resistance to conventional cancer drugs such as chemotherapy. Actuate says elraglusib is also “emerging as a mediator of anti-tumor immunity through the inhibition of multiple immune checkpoints and the regulation of immune cell function.”

The therapy is currently being studied in an open label, randomized Phase 2 study in combination with gemcitabine/nab-paclitaxel for the frontline treatment of patients with metastatic pancreatic cancer. It is also being assessed in Phase 2 studies for the front-line treatment of patients with advanced pancreatic cancer in combination with a checkpoint inhibitor, and in patients with metastatic pancreatic cancer in combination with Folfirinox, a chemotherapy regimen.

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