|Alkermes Receives Fast Track Designation for ALKS 5461; Integra Receives FDA Clearance for Integra(R) Laminoplasty System|
|By Staff and Wire Reports|
|Thursday, 10 October 2013 19:13|
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard therapies. Fast Track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and with the potential to address an unmet medical need.
We are extremely pleased to have been conferred Fast Track status for ALKS 5461 as we believe that ALKS 5461 may represent an important option for the treatment of major depressive disorder, said Elliot Ehrich, Chief Medical Officer of Alkermes (ALKS). This designation supports our position that there is a clear and compelling need for a novel mechanism for the treatment of depression.
Integra LifeSciences Holdings Corporation (NASDAQ: IART) announced the introduction of the Integra® Laminoplasty System, a comprehensive set of implants and instruments designed for use after open-door laminoplasty procedures in the cervical and thoracic spine (C3-T3). The system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and will be featured at the North American Spine Society (NASS) 28th annual meeting, October 9 12, 2013, in New Orleans, Louisiana.
The Integra Laminoplasty System incorporates several plate and screw options, enabling surgeons to treat varying patient anatomies. The user-friendly system includes multiple plate insertion and drill guide options, and a new retentive screw driver, ensuring a seamless approach to laminoplasty procedures.
"We're very pleased that we can now offer surgeons a comprehensive and easy-to-use treatment option for laminoplasty procedures," said Kirt Stephenson, President, U.S. Spine. "Our new Laminoplasty System should be a welcome addition to surgeons' repertoire of spinal therapies."
Laminoplasty procedures treat spinal stenosis by relieving pressure on the spinal cord. The open-door laminoplasty procedure relieves pressure by first cutting the lamina on both sides of the affected vertebrae (a hinge on one side and a groove on the other), and then prying the released segment of lamina open. A laminoplasty plate is attached to the lamina, to help retain the open position while it heals. The plate is also used to hold bone graft material in place and prevent it from expulsion and impinging on the spinal cord.
Aastrom Biosciences, Inc. (Nasdaq:ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, announced today that its board of directors has approved a one-for-twenty reverse stock split of the company's common stock effective on October 16, 2013.
AngioDynamics (Nasdaq:ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today reported financial results for the fiscal 2014 first quarter ended August 31, 2013.
Arch Therapeutics, Inc. (OTCQB: ARTH), is pleased to announce that co-founding and inventing scientist, Dr. Rutledge Ellis-Behnke, will be featured during the opening day activities at the Nanomanufacturing Summit 2013 October 15-17, 2013 at the University of Pennsylvania in Philadelphia.
Can-Fite BioPharma Ltd. (TASE: CFBI) (OTCQB: CANFY), a biotechnology company developing a pipeline of small molecule drugs that address inflammatory and cancer diseases, announced today that the Company will be presenting its cancer drug, CF102, at the 18th World Congress on Advances in Oncology and the 16th International Symposium on Molecular Medicine, which is taking place in Crete, Greece on October 10th through 12th2013.
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that data from three recent studies evaluating the safety and efficacy of Caldolor® (ibuprofen) Injection will be presented at the Annual Meeting of the American Society of Anesthesiologist in San Francisco.
After the first week of the new open enrollment period, eHealth, Inc. (NASDAQ: EHTH), parent company of eHealthInsurance.com, the nation's leading private online health insurance exchange for individual and family health insurance, announced additional resources to help consumers navigate new health plan options under the Affordable Care Act (ACA).
eHealth, Inc. (NASDAQ: EHTH), the nation's first and largest private health insurance exchange, announced today that the company plans to release third quarter 2013 financial results on October 24, 2013.
Fresh Start Private Management Inc. (OTCQB: CEYY), a leader in alcohol treatment and rehabilitation programs, announced today that the second clinic in California that will be offering the Fresh Start Program will open in mid-November.
Gentium S.p.A. (Nasdaq:GENT) announced today that the European Medicines Agency's Committee for Orphan Medicinal Products ("COMP") has issued a positive opinion on the Company's application for orphan medicinal product status for Defibrotide for the prevention of Graft versus Host Disease ("GvHD").
IntelliCell Biosciences, Inc. (OTCQB: SVFC), a regenerative medicine company utilizing adult autologous vascular fraction cells (SVFCs) derived from the blood vessels in lipoaspirate, announced today that it has engaged MD Global Partners, LLC to advise on the company's restructuring, corporate positioning, and strategic opportunities.
Novadaq® Technologies Inc. (NASDAQ:NVDQ) (TSX:NDQ), a developer of clinically-relevant imaging solutions for use in surgical and outpatient wound care procedures, will announce its third quarter 2013 financial results before the market opening on Tuesday, October 22, 2013.
Oncologix Tech Inc. (OTCQB: OCLG), announced today that it has signed a Letter of Intent to acquire a Private Pay healthcare service provider.
Parametric Sound Corporation (NASDAQ: PAMT), a leading innovator of audio products and solutions, today announced that Todd Savitt, vice president of sales and marketing, has been appointed as an executive officer of the company and will lead commercial sales and marketing efforts.
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its third quarter 2013 financial and operating results on Tuesday, November 5, 2013, before the U.S. financial markets open.
SK3 Group, Inc.'s (OTC Pink: SKTO) subsidiary, Medical Greens, is pleased to announce that it has obtained the exclusive license for Dharmanol™ for the State of California.