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Keryx Announces Positive Top-Line Results from Phase 3 Study; Medgenics Files for Orphan Drug Designation for INFRADURE
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 23, 2012.
Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX), announced its Japanese partner, Japan Tobacco Inc. (JT) and Torii Pharmaceutical Co., Ltd. (Torii), has announced positive top-line results from a Phase 3 study of ferric citrate in Japan for the treatment of hyperphosphatemia in end-stage renal disease patients on hemodialysis. This study is part of an ongoing Phase 3 program for ferric citrate in Japan for the treatment of hyperphosphatemia.
The Phase 3 study, conducted in Japan, was an open-label, randomized study evaluating the efficacy and safety of ferric citrate against an active control, sevelamer hydrochloride, over 12 weeks in hemodialysis patients with hyperphosphatemia. In the top-line results, which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of ferric citrate within the treatment period.
JT/Torii stated that it is AIMing to submit the marketing application for ferric citrate in Japan in the fiscal year ending March 31, 2013.
Ron Bentsur, Chief Executive Officer of Keryx, said, "We congratulate our partner, JT/Torii, on their successful Phase 3 study and we are excited by their progress. We are also encouraged about our partner's plans to file their marketing application in Japan within less than a year, similar to our expected timelines for the U.S. NDA and European MAA filings." Mr. Bentsur added, "We are enthusiastic about Zerenex's potential differentiated product profile and its prospects for becoming an important part of the treatment of hyperphosphatemia in dialysis patients worldwide."
Zerenex" (ferric citrate), a ferric iron-based phosphate binder, is also in a Phase 3 clinical program in the United States for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease on dialysis, which is being conducted pursuant to a Special Protocol Assessment agreement with the FDA.
Keryx holds a worldwide license (except for certain Asian Pacific countries) to Zerenex from Panion & BF Biotech, Inc.
Medgenics, Inc. (NYSE: MDGN) announced it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE™ for the treatment of hepatitis D. INFRADURE is based on Medgenics' proprietary tissue-based Biopump™ platform technology, which uses the patient's own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis.
Orphan Drug Designation carries multiple benefits, including the availability of grant money, certain tax credits and seven years of market exclusivity, as well as the possibility of an expedited regulatory process.
Abbott (NYSE: ABT) and St. Jude Medical (NYSE: STJ) today announced Choice Alliance, a multi-year joint initiative that provides mutual U.S. customers access to a robust portfolio of interventional cardiology, cardiac rhythm management, electrophysiology and intravascular imaging and diagnostic technologies.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the election of Dennis A. Ausiello, M.D. to its Board of Directors and Scientific Advisory Board.
Pomerantz Haudek Grossman & Gross LLP is investigating clAIMs on behalf of investors of Ardea Biosciences, Inc. (NASDAQ: RDEA) (ISIN: US03969P1075) concerning the proposed acquisition of Ardea by AstraZeneca in a cash transaction valued at approximately $1.26 billion.
Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the third quarter of fiscal 2012 on Monday, April 30, 2012, and will hold a conference call on Tuesday, May 1, 2012 at 9:00 a.m. Eastern time to discuss these results.
Baxter International Inc. (NYSE:BAX) will webcast its annual meeting of shareholders on Tuesday, May 8, 2012, at 9:00 a.m. Central Time.
BioLineRx Ltd. (NASDAQ:BLRX) (TASE:BLRX.TA), a biopharmaceutical development company, announced the release today of its investor relations app for iPhone, now available for free at the Apple App store on the iPhone or at http://bit.ly/I6oKhw.
BioScrip, Inc. (NASDAQ: BIOS) (the “Company”) today announced that Hai V. Tran has been appointed as Senior Vice President, Chief Financial Officer and Treasurer effective May 14, 2012.
BioTime, Inc. (NYSE Amex: BTX) announced today that David Warshawsky, Ph.D., CEO of BioTime’s subsidiary LifeMap Sciences, Inc. will provide and update on product development at an investor meeting in New York City today.
Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that Biovest and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) have entered into a Cooperative Research and Development Agreement (CRADA) to further develop Biovest’s hollow fiber perfusion bioreactors as a flexible and modular manufacturing platform for the rapid, robust and cost-effective production of medical countermeasures to emerging and genetically engineered infectious diseases.
Capsalus Corp. (OTCBB: WELL and, temporarily, OTCBB: WELLE), today announced that the necessary revenue numbers for its fourth quarter are not yet available to include in its Fiscal 2011 10-K annual report for the fiscal year ending Dec. 31, 2011 due to a required change in GeneLink Biosciences, Inc. (OTCBB: GNLK) auditors.
Catalyst Health Solutions, Inc., (NASDAQ: CHSI) today announced that Mercer, one of the world’s leading human resource consulting firms, has selected Catalyst Rx to participate in the Mercer Pharmacy Collective making them a preferred provider of Pharmacy Benefit Management (PBM) services for the employers belonging to the Mercer Pharmacy Collective.
Compugen Ltd. (NASDAQ: CGEN) today announced that the Company will host a conference call at 10:00 AM EST on Tuesday, May 1, 2012 to review first quarter 2012 results.
Compugen Ltd. (NASDAQ: CGEN) announced today that Dr. Mary Haak-Frendscho, Compugen Inc.'s Executive Chairperson of the Board, will deliver the keynote address at the 7th International China Pharmaceutical R&D Summit, on April 24, 2012 in Shanghai, China.
CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company specializing in oncology, today announced that it has received a favorable ruling from the NASDAQ Hearings Panel (the “Panel”), whereby the Panel has granted the Company’s request to remain listed on The NASDAQ Capital Market.
Exact Sciences Corp. (Nasdaq: EXAS) today announced that the company will host a webcast and conference call to discuss its first-quarter 2012 financial results on May 1, 2012.
Five Star Quality Care, Inc. (NYSE: FVE) today announced that it will host a conference call in conjunction with the announcement of its first quarter 2012 financial results.
Illumina, Inc. (NASDAQ:ILMN) today announced its financial results for the first quarter of 2012.
InSite Vision Incorporated (OTCBB: INSV) announced today that it will report financial results for the first quarter ended March 31, 2012 on Tuesday, May 1, 2012.
International Stem Cell Corporation (ISCO.OB), today announced that several of its senior scientists, led by Dr. Ruslan Semechkin Vice President Research and Development, will present the results of their most recent experiments on the therapeutic use of human parthenogenetic stem cells (hpSCs) in Parkinson’s disease at the 64th Annual Meeting of American Academy of Neurology in New Orleans (April 21 to 28 2012).
International Stem Cell Corporation (OTCBB: ISCO) today announced it has appointed MZ Group as its investor relations advisor.
Landec Corporation (Nasdaq:LNDC), a company that develops and markets patented products for food, agricultural and biomedical applications, announced today that its wholly owned food subsidiary, Apio, Inc., has acquired GreenLine Foods, Inc. from The Riverside Company, a global private equity firm.
Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE™ for the treatment of hepatitis D. INFRADURE is based on Medgenics’ proprietary tissue-based Biopump™ platform technology, which uses the patient’s own tissue to continuously produce and deliver therapeutic proteins, such as interferon-alpha for use in the treatment of hepatitis.
Natus Medical Incorporated (NASDAQ:BABY) today announced that Natus management will host an investment-community conference call this morning, Monday, April 23, 2012 beginning at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time) to discuss the acquisition announced earlier today.
NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the diagnosis and treatment of neurological complications of diabetes announced that it will support a clinical study entitled “Evaluation of the Effect of Intensive Diabetes Control Through Non-surgical Intensive Lifestyle Modifications and Weight Reduction on Diabetic Peripheral Neuropathy”.
Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Company will report first quarter 2012 financial results following the close of the U.S. financial markets on Monday, May 7, 2012.
Spectrum Pharmaceuticals (NasdaqGS:SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that in order to meet the needs of cancer patients in the United States, the Company has substantially increased its manufacturing capacity of FUSILEV® (levoleucovorin) for injection, since its approval for use in advanced metastatic colorectal cancer.
W. R. Grace & Co. (NYSE: GRA), in partnership with Formac Pharmaceuticals NV, a research and development pharmaceutical company, announced today positive data from initial human studies enabled by the companies’ unique mesoporous silica-based drug delivery technology.
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