Drugs

GSK, Innoviva sNDA for Trelegy Ellipta in Asthma

GlaxoSmithKline and Innoviva have submitted a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in adults. Trelegy Ellipta was originally approved 9/2017 for treating patients with chronic obstructive pulmonary disease (COPD). The submission is based on data from the pivotal Phase 3 clinical study (CAPTAIN) conducted in 2,436 adult patients with uncontrolled asthma across 15 countries. The CAPTAIN study demonstrated that the once-daily single inhaler triple therapy met the study’s primary endpoint of significant improvement in lung function compared with fluticasone furoate and vilanterol in patients with uncontrolled asthma, the companies said.

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