Drugs

Heron NDA Resubmission for Post-Op Pain Drug

FDA has accepted for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain. The agency has set a user fee review action date of 3/26/2020. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on an April complete response letter which requested additional chemistry, manufacturing and controls and non-clinical information.

HTX-011 is described by the company as a long-acting, extended-release formulation of the local anesthetic bupivacaine in fixed-dose combination with the anti-inflammatory meloxicam. Heron says HTX-011 has been shown to reduce pain significantly better than placebo or bupivacaine solution in five surgical models: hernia repair, abdominoplasty, bunionectomy, total knee arthroplasty, and breast augmentation.

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