Flexion Therapeutics (NSDQ:FLXN) this week touted updated, interim results from an ongoing Phase IIIb study evaluating the safety and tolerability of repeat administration of its osteoarthritis injection, Zilretta. The company’s injectable suspension is an extended-release formulation of triamcinolone acetonide designed for patients with osteoarthritis of the knee. Top-line results from Flexion’s trial showed that 95% of […]
SureFire Medical names pharma vet Szela as president, CEO | Personnel Moves – Jan. 26, 2018
SureFire Medical has named pharma veteran Mary Szela as its president, CEO and board member, succeeding founder James Chomas, who has served as the company’s chief executive and president since 2009. Chomas will assume the role of chief technology officer and oncology strategy officer, focusing his efforts on the the company’s oncology drug-delivery tech. “Immune […]
Flexion CEO: Setting Zilretta up to succeed with a history lesson
Locally acting therapies are like a religion to Flexion Therapeutics (NSDQ:FLXN) co-founder & CEO Dr. Mike Clayman, who spent decades at Eli Lilly (NYSE:LLY) with the company’s co-founder, Dr. Neil Bodick, watching promising compounds fail in late-stage trials on the heels of unanticipated safety results. “That’s part of the reason, not the whole reason but part of […]
After FDA nod, Flexion launches osteoarthritis injection
Flexion Therapeutics (NSDQ:FLXN) today launched its Zilretta therapy designed to help patients manage pain associated with osteoarthritis of the knee. The Burlington, Mass.-based company’s extended-release intra-articular injection combines a commonly administered, short-acting corticosteroid with a polylactic-co-glycolic acid matrix using Flexion’s microsphere technology. The FDA approved Zilretta last month after granting it fast track status in 2015. […]
FDA accepts Flexion’s NDA for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that the FDA accepted its New Drug Application for Zilretta – its extended-release steroid injection. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection in 2015. Flexion touts Zilretta as the 1st intra-articular, extended-release therapy for patients with knee osteoarthritis pain. The injection uses microsophere technology […]
Flexion seeks FDA nod for osteoarthritis steroid injection
Flexion Therapeutics (NSDQ:FLXN) said today that it submitted a new drug application to the FDA for its extended-release steroid injection Zilretta. The Burlington, Mass.-based company won Fast Track status from the watchdog for its osteoarthritis injection last year. The new drug application is based on data from a pivotal phase III clinical trial evaluating Zilretta in […]
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