Drugs

FDA Approves Entyvio Subcutaneous Dosing

FDA has approved a subcutaneous (SC) administration device (single-dose pre-filled pen) for Takeda’s Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis after induction therapy with Entyvio intravenous. The drug was originally approved in 2014 for treating adult patients with moderate to severe ulcerative colitis and adult patients with moderate to severe Crohn’s disease whose previous treatment with standard therapies have not resulted in an adequate response.

The approval for the new administration route was based on data from the VISIBLE 1 study, which demonstrated that Entyvio SC can provide physicians with an additional administration option for achieving remission in their moderate to severe ulcerative colitis patients, the company says. “A statistically significant proportion of patients receiving Entyvio SC 108 mg maintenance therapy administered every two weeks achieved clinical remission compared to patients receiving placebo (46% vs. 14%; p<0.001) at Week 52,” it adds.

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