|IGI Labs Announces First ANDA Approval for Lidocaine Hydrochloride; PreClinical Results for Pluristem's PLX-PAD Cells|
|By Staff and Wire Reports|
|Wednesday, 12 March 2014 19:51|
IGI Laboratories, Inc. (NYSE MKT: IG), a New Jersey based generic topical pharmaceutical company, today announced it has received its first approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA). The FDA has approved IGI's application for lidocaine hydrochloride USP 4% topical solution.
Lidocaine hydrochloride USP 4% topical solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. Based on recent IMS Health data, the total addressable market for this product is approximately $1.8 million. IGI originally submitted this ANDA to the FDA in May, 2012.
Jason Grenfell-Gardner, President and CEO of the Company, commented, "Today's action by the FDA marks a true turning point in the transformation of IGI. With our first drug approval, organically generated from beginning to end within IGI, we have validated our team's ability to deliver on R&D. Although this particular drug is the smallest opportunity in our pipeline, it is an important milestone for demonstrating IGI's capabilities. With now 13 further applications pending, and at least nine more filings planned this year, IGI will continue to execute its R&D plan as part of our goal of being a leading player in the generic topical pharmaceutical market."
Pluristem Therapeutics, Inc. (PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapies, today announced that Dr. Scott Rodeo of New York's Hospital for Special Surgery (HSS) presented his research findings in a scientific poster titled, "Use of Human Placental-Derived Adherent Stromal Cells Improves Tendon Healing in a Preclinical Model of Tendon Injury," at the American Academy of Orthopedic Surgeons' (AAOS) Annual Meeting, on March 11-15 in New Orleans.
At the AAOS meeting, Dr. Rodeo's poster presentation concluded that: a) placental-expanded cell therapy appeared to have an early beneficial effect on tendon healing following collagenase injury in this preclinical model; b) since these cells are immune-privileged and are expanded ex vivo, its potential for "off-the-shelf" use is attractive relative to existing cell-based therapies; and c) additional preclinical studies are necessary to understand how these cells may affect tendon repair.
"Although our findings should be considered preliminary, adherent stromal cells derived from human placenta appear promising as a readily available cell source to aid tendon healing and regeneration," stated Dr. Rodeo.
"These detailed preclinical results, as well as the favorable top-line results we announced from our Phase I/II muscle injury study in January, both validate our strategy to pursue advanced clinical studies of our PLX cells for the sports and orthopedic market," stated Pluristem CEO Zami Aberman.
Dr. Rodeo and his orthopedic research team at HSS studied the effects of Pluristem's PLacental eXpanded (PLX)-PAD cells in a preclinical model of patellar tendons that had sustained collagenase-induced injuries. Favorable results from the study were announced by Pluristem on August 14, 2013. Dr. Rodeo, the Principal Investigator for this study is Professor of Orthopedic Surgery at Weill Cornell Medical College; Co-Chief of the Sports Medicine and Shoulder Service at HSS; Associate Team Physician for the New York Giants Football Team; and Physician for the U.S.A. Olympic Swimming Team.
Akers Biosciences, Inc. (LSE:AKR) (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products, today announces that President and CEO Thomas A. Nicolette will be stepping down from the board and leaving the Company, effective March 28, 2014.
BG Medicine, Inc. (Nasdaq:BGMD) welcomed today an announcement by La Jolla Pharmaceutical Company (LJPC) on March 10, 2014 of positive top-line results of its randomized, placebo-controlled Phase 2 trial of the galectin-3 inhibitor compound GCS-100 in chronic kidney disease.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today the enrollment of the first patient in its "PUMA" (PROHEMA® in UMbilical cord blood transplant in Adults) study, a Phase 2 clinical trial of PROHEMA® (16, 16-dimethyl prostaglandin E2, or dmPGE2, modulated cord blood) using the Company's nutrient-rich media formulation.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the home care setting, announced today that it will release its financial results for the fourth quarter of 2013 after the close of trading on Thursday, March 27, 2014.
Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX), a biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of renal disease, today announced its financial results for the fourth quarter and year ended December 31, 2013.
Kips Bay Medical, Inc. (Nasdaq:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting surgery, today provided a business update and announced financial results for its fourth quarter and full year ended December 31, 2013.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate in two investor conferences next week.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability and clinical systems that seek to advance healthcare, today announced NexxRad Teleradiology Partners, provider of professional radiology services via teleradiology, will implement Merge PACS™, Merge's real-time picture archiving communication system.
Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, will announce its fourth quarter and year-end financial results for 2013 and give an operational update in a press release to be issued before the market opens on Thursday, March 20, 2014.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a specialty biopharmaceutical company which develops botulinum toxin products for use in aesthetic and therapeutic indications, today announced that the company will release fourth quarter and full year 2013 financial results on Wednesday, March 26, 2014 after the close of market.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2013.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today reported financial results for the fourth quarter and full year 2013 and discussed key company developments.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that its subsidiary, Symmetry Surgical, is launching the newest innovation in its industry-leading Bookwalter® portfolio, the Bookwalter® Femoral Elevator, at the Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, March 11-15, 2014.