Below is a look at some of the headlines for companies that made news in the healthcare sector on August 6, 2013.
Cardium Therapeutics (NYSE: CXM) announced it has entered into an agreement with Orbsen Therapeutics Ltd and the National University of Ireland, Galway, to utilize Cardium's Excellagen® pharmaceutically-formulated gel as a delivery agent for Orbsen's proprietary stromal cell therapy in pre-clinical studies for the potential treatment of diabetic foot ulcers. The research is being conducted by the Regenerative Medicine Institute (REMEDI), at the National University of Ireland Galway (NUIG), a world-class biomedical research centre focused on mesenchymal stromal cell (MSC) research. The research initiative is funded by REDDSTAR, a European Union Framework 7 (EU FP7) research collaboration focused on treating diabetes and its complications with a defined MSC therapy and enlisting academic and industry partners throughout Europe in the program (www.reddstar.eu).
Cardium's FDA-cleared Excellagen is an aseptically-manufactured, quaternary fibrillar Type I bovine collagen homogenate that is configured into a staggered array of three-dimensional, triple helical, telopeptide-deleted, tropocollagen molecules. This linear array forms a flowable, biocompatible and bioactive structural matrix that promotes chemotaxis, cellular adhesion, migration and proliferation to stimulate tissue formation. The Excellagen homogenate represents a new product delivery platform that allows for the potential development of a portfolio of advanced tissue regeneration therapeutic opportunities that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media.
Chelsea Therapeutics International, Ltd. (NASDAQ:CHTP) today reported financial results for the second quarter ended June 30, 2013. "Chelsea continues to diligently manage its financial resources, which are projected to fund operating expenses into the third quarter of 2014, as we work to finalize our NDA submission for NORTHERA" (droxidopa) in the treatment of symptomatic Neurogenic Orthostatic Hypotension (NOH)," said Joseph G. Oliveto, Interim CEO of Chelsea. "We anticipate that this effort will be completed in August, at which point a new PDUFA date, expected in the first quarter of 2014, will be set by the Agency."
Recent Highlights--In early July 2013, Chelsea resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market Northera for the treatment of symptomatic NOH. On July 29, Chelsea reported that the U.S. Food and Drug Administration (FDA) identified certain technical difficulties with the resubmitted New Drug Application (NDA). The Company expects to submit the necessary response in August 2013, at which point a new six month Prescription Drug User Fee Act (PDUFA) review clock is expected to begin.
In June 2013, Chelsea was added to the Russell 3000® and Russell 2000® Indexes when the Russell Investment Group reconstituted its family of U.S. indexes.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., announced today financial results for the second quarter of fiscal year 2013, ended June 30, 2013.
Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced that it will report second quarter 2013 operational results after closing of the NASDAQ Global Market on August 13, 2013.
Arch Therapeutics, Inc. (OTCQB: ARTH), a life science company and developer of AC5™, a novel product aimed at controlling bleeding and fluid loss in order to provide faster and safer surgical and interventional care, is pleased to provide a brief review of proposed future activities.
Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company™, today announced that it will issue financial results and corporate highlights for the quarter ended June 30, 2013, following the close of market on Wednesday, August 14, 2013.
Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) today reported financial results for the three and nine-months ended June 30, 2013.
Bio-Rad Laboratories, Inc. (NYSE: BIO) and (NYSE: BIO.B), a multinational manufacturer and distributor of life science research and clinical diagnostic products, announced financial results today for the second quarter ended June 30, 2013.
Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) today reported financial results for the second quarter ended June 30, 2013.
China Biologic Products, Inc. (NASDAQ: CBPO), a leading fully integrated plasma-based biopharmaceutical company in China, today announced its unaudited financial results for the second quarter of 2013.
Covance Inc. (NYSE: CVD), one of the world's largest and most comprehensive drug development services companies, announced the creation of a new service offering focused on providing its biopharmaceutical and medical device clients support to effectively manage contracts in managed markets.
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company and leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging diagnostics for personalized therapy in cancer and other serious diseases, today announced the company's management team will present at the Wedbush 2013 Life Sciences Management Access Conference on Tuesday, Aug. 13, at 8 a.m. The conference is being held in New York.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today reported financial results for its second quarter 2013, and provided an update on recent accomplishments.
MediSwipe Inc. (OTCQB: MWIP), a patient security solutions and software development company for the medicinal marijuana and health care industry, and 800 Commerce Inc., an innovative online directory and mobile marketing company, today announced the status of the fifth round of comments and filing of the amended S-1A registration statement to the Securities and Exchange Commission.
Mesa Laboratories, Inc. (NASDAQ: MLAB) today reported a six percent increase in revenues for the first quarter ended June 30, 2013.
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that its presentation at the Canaccord Genuity 33rd Annual Growth Conference will be webcast on Wednesday, August 14 at 2:30 p.m. ET.
Nanosphere, Inc., (NASDAQ: NSPH) a company enhancing medicine through targeted molecular diagnostics, today reported financial results for the second quarter ended June 30, 2013.
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the three and six months ended June 30, 2013.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced results for the second quarter 2013.
Novavax, Inc. (Nasdaq:NVAX) a clinical-stage vaccine company, announced today that Stanley C. Erck, President and Chief Executive Officer of Novavax, will present at the 2013 Wedbush Life Sciences Management Access Conference on Wednesday, August 14, 2013 at 10:55 a.m. ET in New York City at the Le Parker Meridien.
Oncothyreon Inc. (NASDAQ: ONTY) today reported financial results for the second quarter ending June 30, 2013.
Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced business and financial results for the second quarter ended June 30, 2013.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the quarter ended June 30, 2013.
Pluristem Therapeutics Inc. (Nasdaq: PSTI) (TASE:PLTR) today announced that its wholly owned subsidiary, Pluristem Ltd., has received approval for a 12 million New Israeli Shekels (approximately $3.3 million) grant from the Office of the Chief Scientist (OCS) within the Israeli Ministry of Economy.
Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced that it will report financial results and highlights for the quarter ended June 30, 2013 on Tuesday, August 13, 2013, after the U.S. financial markets close.
Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH), is pleased to announce that it has issued a letter from Stellar President and CEO Frank Oakes, to update shareholders on the status of the Company.
Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN), today announced that the Company expects to report financial results for the quarter ended June 30, 2013 after the market closes on Tuesday August 13, 2013.
Titan Medical Inc. (TSX VENTURE:TMD) (OTCQX:TITXF) announced today its results for the three and six months ended June 30, 2013.
Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremities specialists, reported today its financial results for the second quarter ended June 30, 2013.
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering.
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