Wright Medical steps forward with knee licence:
This article was originally published in Clinica
Wright Medical is to license a total knee prosthesis, the 913 knee, developed by the New York Hospital for Special Surgery. According to Wright chairman and CEO Herbert Korthoff: "This agreement will give us a substantial head start in developing a new prosthesis involving the sacrifice of the posterior cruciate ligament. This surgical technique is the most rapidly growing part of the total knee replacement market."
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.