Auxilium Announces U.S. Food And Drug Administration Approval For XIAFLEXTM For The Treatment Of Dupuytren's Contracture
Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March. "We believe the approval of XIAFLEX represents a major breakthrough for patients suffering from the debilitating effects of Dupuytren's contracture, " said Armando Anido, Chief Executive Officer and President of Auxilium.
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Researchers at North Carolina State University have developed a "smart coating" that helps surgical implants bond more closely with bone and ward off infection. When patients have hip, knee or dental replacement surgery, they run the risk of having their bodies reject the implant. But the smart coating developed at NC State mitigates that risk by fostering bone growth into the implant. The coating creates a crystalline layer next to the implant, and a mostly amorphous outer layer that touches the surrounding bone. The amorphous layer dissolves over time, releasing calcium and phosphate, which encourages bone growth. "The bone grows into the coating as the amorphous layer dissolves, resulting in improved bonding, or osseointegration, " says Dr.
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