BioMimetic Therapeutics Inc announced that the US Food & Drug Administration (FDA) has accepted for review its Premarket Approval (PMA) application for Augment Bone Graft for use in foot and ankle fusions in the US. The FDA has now filed the application and begun the comprehensive review of the clinical module, the company added.

Denosumab, a potential game-changer for Amgen Inc, is expected to be the most notable launch in the biotech industry in years. However, many on Wall Street expect the FDA’s approval decision to be delayed by about three months from the expected date of October 19 because the agency has a history of missing deadlines and may want more time to analyze the safety record of a new drug like denosumab.

Auxilium Pharma is awaiting a decision from the FDA on its key pipeline candidate, Xiaflex, for the treatment of Dupuytren’s Contracture. The drug has received favorable recommendation from the FDA’s Arthritis Advisory Committee. Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that about 240,000 people suffer from Dupuytren’s in the US and the EU. This represents significant commercial opportunity for Auxilium.

The Orthopaedic and Rehabilitation Devices advisory committee has unanimously recommended the FDA approval of DePuy Orthopaedics’ Pinnacle CoMplete Acetabular Hip System, the first ceramic-on-metal hip bearing to be considered for approval in the US. The recommendation was based on the clinical study comparing Pinnacle CoMplete System to a commonly used DePuy metal-on-metal implant on the efficacy and safety. Laboratory testing on the Pinnacle CoMplete System showed a greater than 90% reduction in wear compared to the metal-on-metal system under normal gait conditions and a more than 80% reduction in wear under adverse conditions.

Health Canada has approved FzioMed, Inc.’s Oxiplex(R) gel for use in lumbar spine surgery.Oxiplex is an absorbable gel that is applied to spinal nerve roots during lumbar laminectomy, laminotomy and discectomy procedures. Oxiplex creates a temporary, protective barrier against the damaging effects of excessive fibrosis, inflammation and other irritants that can lead to recurrent postoperative pain.

Oxiplex is now approved in 49 countries and has been used in nearly 100,000 surgeries. Health Canada’s approval of Oxiplex for spine surgery was based on final data from a U.S. multi-center, randomized, blinded, controlled study involving 352 patients. The company has filed a Pre-Market Approval Application with the FDA seeking approval to market Oxiplex in the U.S.

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