|Bioheart Announces World's First Combination Stem Cell Treatment; Allergan Announces OZURDEX® Receives European Positive Opinion|
|By Staff and Wire Reports|
|Friday, 25 July 2014 18:25|
Bioheart, Inc. (OTCQB: BHRT) announced it has completed the world's first combination stem cell treatment with Magnum Cell Therapies (Magnum) in Honduras. A patient with congestive heart failure has been treated with a combination of AdipoCell™ or adipose derived stem cells and MyoCell® or muscle derived stem cells. AdipoCell may help to promote angiogenesis or new blood vessel formation in ischemic tissue while MyoCell may help to promote myogenesis or new muscle formation. The cells were delivered directly into the damaged areas of the heart using the MyoCath® Catheter.
The patient was treated at the Honduras Medical Center (http://www.hmc.com.hn/index.php?page=main) with Managing Director Dr. Ricardo Aguilar. The procedure was led by cardiologists Dr. Haroldo Lopez and Dr. Raul Marenco.
Kristin Comella, Bioheart's Chief Scientific Officer, attended the case and said, "We are bringing new regenerative therapies to many patients around the world. We believe that this new method of cell combination is the best therapy available to patients suffering from heart failure."
"Magnum has brought cutting edge regenerative therapies to Honduras," said Dr. Rene Fiallos, Magnum's Chief Medical Officer. "We are seeing excellent results so far with stem cell therapy and we are thrilled to expand our services."
Allergan, Inc. (NYSE: AGN) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX® (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema (DME) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. The CHMP is the scientific committee of the European Medicines Agency (EMA) that recommends medicines for Marketing Authorization across the 28 member states of the European Union. The final decision from the European Commission is expected within a few months.
“With a commitment to the development of innovative treatment options that address unmet patient needs, we are pleased with the CHMP’s recommendation to expand the license for OZURDEX® , an important tool in the armamentarium of the European retinal specialist, as evidenced by the fact that OZURDEX® sales are currently more than twice those of the United States,” said David E.I. Pyott, Allergan's Chairman of the Board and Chief Executive Officer. "Allergan is widely recognized for having one of the most productive R&D pipelines in the industry and secured a record 180-plus approvals for products and indications around the world last year. Our ability to advance R&D programs allows us to continually bring forth new treatment options for physicians and their patients while delivering value to our stockholders.”
DME is a condition that affects approximately 7% of patients with diabetes1 and is the leading cause of sight loss in patients with diabetes.2 The OZURDEX® implant uses the proprietary and innovative NOVADUR® solid polymer delivery system – a biodegradable implant that releases medicine over an extended period of time – to suppress inflammation, which plays a key role in the development of DME.
“OZURDEX® is a leading treatment for macular edema in patients with retinal vein occlusion and uveitis in Europe, and is approved for multiple indications in the United States including most recently for use in certain patients with diabetic macular edema,” said Scott M. Whitcup, M.D., Allergan’s Executive Vice President, Research and Development, Chief Scientific Officer. "DME is a complicated disease to treat, and the additional license for OZURDEX® in the EU would offer another important treatment option to help preserve vision for patients.”
OZURDEX® is already available throughout the European Union as a treatment licensed for macular edema in patients with retinal vein occlusion (RVO) and for inflammation of the posterior segment of the eye characterized as non-infectious uveitis.
Amgen (NASDAQ: AMGN) announced that its Board of Directors today declared a $0.61 per share dividend for the third quarter of 2014. The dividend will be paid on Sept. 5, 2014, to all stockholders of record as of the close of business on Aug. 14, 2014.
Assembly Biosciences, Inc. (Nasdaq:ASMB), a biopharmaceutical company developing innovative treatments for hepatitis B virus (HBV) and C. difficile-associated diarrhea (CDAD,) today announced that it will not pursue further development of VEN 307, an investigational product for the treatment of anal fissures.
Derma Sciences, Inc. (Nasdaq:DSCI), a tissue regeneration company focused on advanced wound care, announces that Edward J. Quilty, its chief executive officer, delivered a presentation highlighting MEDIHONEY® and its robust growth at the Comvita Ltd. annual meetings of shareholders in New Zealand on Thursday, July 24.
Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA), a leader in the development of RNAi-based therapeutics, today announced that the Company will release its second-quarter 2014 financial results after market close on Thursday, August 7.
Galectin Therapeutics (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announced the Company will hold a webcast on Tuesday, July 29, 2014 at 8:30 a.m. Eastern Daylight Time to discuss the findings from cohort 2 of a Phase 1 clinical trial evaluating its galectin inhibitor GR-MD-02 in fatty liver disease (NASH) with advanced fibrosis.
Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig® (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL).
Immune Design (Nasdaq:IMDZ) announced today that the day after it began trading on the Nasdaq Global Market, Theravectys SA ("TVS") filed a lawsuit against the company repeating claims that it had made in a prior lawsuit which TVS had earlier voluntarily dismissed.
Lion Biotechnologies, Inc. (OTCQB:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor infiltrating lymphocytes (TILs), today announced that it has entered into an exclusive, worldwide license agreement with Moffitt Cancer Center.
Novogen Ltd. (ASX; NRT: NASDAQ; NVGN), today announced that they have named two key contract manufacturing organizations (CMOs) to produce clinical batches of the experimental anti-cancer drug, Cantrixil™.
Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced that it will release its second quarter 2014 financial results before the U.S. stock market opens on Monday, August 11, 2014 and has scheduled a conference call at 10:00 a.m. EDT that day to discuss the financial results.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will hold its quarterly conference call to discuss second quarter results on Thursday, July 31, 2014 at 4:30pm Eastern Time.
Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today that it will host an investor meeting on Wednesday, September 17, 2014, at approximately 10:00 am to 1:00 pm ET in New York City.
Vitacost.com, Inc. (Nasdaq:VITC) a leading online retailer of healthy living products, announced today that it has been ranked #5 for fastest Order Life Cycle, a metric that combines the total days to deliver an order with the total days to process a refund, according to StellaService, a company that measures the customer service performance of online retailers.