|Aegerion Announces Date of FDA Advisory Committee Review of Lomitapide NDA; FDA Accepts CRS Regarding Ampligen NDA|
|By Staff and Wire Reports|
|Tuesday, 14 August 2012 19:58|
Aegerion Pharmaceuticals, Inc. (Nasdaq: AEGR), an emerging biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat debilitating and often fatal rare diseases, announced the U.S. FDA has scheduled a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee on October 17, 2012, to review the Company's New Drug Application for lomitapide in the treatment of adult patients with Homozygous Familial Hypercholesterolemia (HoFH).
Details of the meeting will be available in the Federal Register.
Hemispherx Biopharma, Inc. (NYSE: HEB) filed on July 31, 2012 with the U.S. FDA its complete response to the FDA's November 25, 2009 Complete Response Letter in support of Ampligen®'s New Drug Application for Chronic Fatigue Syndrome ("CFS").
On August 10, 2012, the FDA acknowledged in writing receipt of the Company's August 1, 2012, response stating, "We consider this a complete, class 2 response to our November 25, 2009, action letter. Therefore, the user fee goal date is February 2, 2013."
Arrhythmia Research Technology, Inc. (NYSE MKT: HRT) and its subsidiaries reported total revenue of $4,977,000 and net loss of $1,040,000 for the three months ended June 30, 2012 compared to total revenue of $6,018,000 and net loss of $255,000 for the same quarter of 2011.
BioLife Solutions, Inc. (OTCBB: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced record results for the second quarter ended June 30, 2012.
Cardium Therapeutics (NYSE MKT: CXM) today presented its financial results for the second quarter ended June 30, 2012 and reported on other recent developments including: (1) agreement with Advanced Biosciences Research, an affiliate of bioRASI, for the planned commercialization of Excellagen®physician-use wound care product in the Russian Federation and the CIS; (2) agreement with Angel Biomedical for the manufacture of Excellagen and to assist Cardium in filing for a CE Mark for the potential marketing and sale of Excellagen in the European Union; (3) selection of Excellagen as one of the top ten podiatry innovations in 2012 by Podiatry Today publication; (4) publication of important research findings that have been incorporated into the treatment protocols of the Company's Generx® ASPIRE Phase 3 / registration study for patients with advanced coronary disease; and (5) introduction of the Neo-Chill Nutra-App® to the Company's MedPodium® healthy lifestyle product platform. Consistent with its long-term business strategy, Cardium continues to identify and evaluate businesses, product opportunities and technologies for potential acquisition on favorable economic terms consistent with the Company's long-term business strategy.
CONMED Corporation(NASDAQ: CNMD) and Viking Systems, Inc.(OTCBB: VKNG) (OTCQB: VKNG) today announced that the companies have entered into a definitive agreement providing for CONMED to acquire Viking for $0.27 per share in cash.
CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to modulate the immune system to prevent or treat organ failure caused by life-threatening illnesses, announced a corporate update and its financial results for the three months ended June 30, 2012.
Deaf-Talk, Inc. (PINKSHEETS: MGQG), dba DT Interpreting (DTI), the industry leader in on-demand video sign language interpreting, today announced that it is experiencing a significant surge in new and renewed contracts, with installations over the last several months of 87 new mobile video units dedicated to on-demand ASL video interpreting.
Dyadic International, Inc. ("Dyadic") (OTC Pink: DYAI), a global biotechnology company focused on the discovery, development, manufacture and sale of enzymes and other proteins for the bioenergy, bio-based chemicals, biopharmaceutical and industrial enzyme industries, today announced financial results for the second quarter and six months ended June 30, 2012.
Graymark Healthcare, Inc. (NASDAQ: GRMH), the nation's second largest provider of diagnostic sleep services and an innovator in comprehensive care for obstructive sleep apnea (OSA), reported financial results for the second quarter ended June 30, 2012.
Graymark Healthcare, Inc. (NASDAQ: GRMH) and Foundation Healthcare Affiliates, LLC today jointly announced the signing of a definitive agreement for Graymark to acquire 100% of the equity interest of Foundation Surgical Hospital Affiliates, LLC, and Foundation Surgery Affiliates, LLC from Foundation Healthcare Affiliates in a transaction valued at $1.10 per common share for an aggregate transaction value of approximately $52.5 million.
Home Health International Inc. (PINKSHEETS: HHII), a Medicare-certified home health agency and durable medical equipment (DME) supplier, announced today that it has accepted initial contract terms for an FDA approved supplement company to supply its patients with needed treatments and vitamins at considerable discounts.
Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company dedicated to the development of innovative inhaled pharmaceuticals for the treatment of serious lung infections, today announced that Timothy Whitten, President and Chief Executive Officer, will be presenting a corporate overview at the 2012 Wedbush PacGrow Life Sciences Management Access Conference in New York on Wednesday, August 15, 2012, at 8:35 AM ET.
M Line Holdings, Inc. (OTCBB: MLHC), announced today that it has retained Hong Kong Alliance Fund Limited, ("HK Alliance") to represent the Company to investors, potential shareholders and customers, internationally, specifically in the Far East.
MultiCell Technologies, Inc. (OTCBB: MCET.OB), a clinical-stage biopharmaceutical company developing novel therapeutics and discovery tools that address unmet medical needs for the treatment of neurological disorders, hepatic disease and cancer, announced the results from its annual shareholders meeting held Friday, August 10, 2012 in San Diego, CA.
PDI, Inc. (Nasdaq: PDII), today reported financial and operational results for the second quarter ended June 30, 2012.
Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for helping determine a patient's response to cancer therapy, today announced its consolidated financial results for the second quarter ended June 30, 2012.
Stellar Pharmaceuticals Inc. (OTCQB:SLXCF)(OTCBB:SLXCF)(PINKSHEETS:SLXCF) ("Stellar" or "the Company"), an emerging specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today announced financial results for the period ended June 30, 2012.
Viking Systems, Inc. (OTCBB: VKNG), a leading worldwide developer, manufacturer and marketer of 3D and 2D visualization solutions for complex minimally invasive surgery today announced results for the quarter ended June 30, 2012.
VirtualScopics, Inc. (NASDAQ: VSCP), a leading provider of quantitative imaging, today reported revenues of $3,335,861 for the second quarter of 2012 compared to revenues of $3,852,925 in the second quarter of 2011.
WuXi PharmaTech (Cayman) Inc. (NYSE: WX), a leading research and development outsourcing company serving the pharmaceutical, biotechnology, and medical device industries, with operations in China and the United States, today announced its financial results for the second quarter of 2012.
ZYTO Corp (OTCBB: ZYTC) (www.ZYTO.com) a Utah-based biotech company specializing in biocommunication applications, today reported net income of $31,270 for the second quarter of 2012, compared to a net loss of $66,238 for the same quarter last year, reflecting an increase of $97,508.