Drugs

Oramed Shelves Diabetes Drug After Phase 3 Miss

Oramed Pharmaceuticals says it is discontinuing clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial (ORA-D-013-1) missed its primary and secondary endpoints. The trial enrolled 710 Type 2 patients who experienced inadequate glycemic control on two or three oral glucose-lowering agents.

According to the company, the missed primary endpoint compared the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by the mean change from baseline in A1C at 26 weeks. The missed secondary endpoint assessed the mean change from baseline in fasting plasma glucose at 26 weeks. There were no serious drug-related adverse events.

Oramed say the when the full data from the studies are available, it expects to share relevant information and future plans.

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