Devices

FDA Accepts Vericel BLA for Knee Cartilage Repair

FDA has accepted for review a Vericel BLA for MACI (matrix applied characterized autologous cultured chondrocytes), an investigational autologous cellular product intended for treating symptomatic cartilage defects of the knee in adult patients. The agency has set a user fee review target date of 1/3/2017. Additionally, the company says FDA informed it that there are no current plans to hold an advisory committee meeting to discuss the application.

The third-generation implant comprises autologous cultured chondrocytes seeded onto a resorbable Type I/III collagen membrane. The human-derived cells are obtained from the patient's own cartilage in order to manufacture MACI, according to the company.

The submission is supported by pivotal Phase 3 data from the clinical trial SUMMIT (Superiority of MACI Implant to Microfracture Treatment) and the three-year SUMMIT Extension trial. SUMMIT was a two-year, prospective, multicenter, randomized, open-label, parallel-group clinical trial designed to evaluate the safety and efficacy of MACI to reduce pain and improve function compared with arthroscopic microfracture. the company says.

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

Read more

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