FDA Panel Rules Favorably on Theravance's VIBATIV; NPS Publishes Pivotal Phase 3 Study of Gattex Print E-mail
By Staff and Wire Reports   
Thursday, 29 November 2012 20:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 29, 2012.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that its Phase 3 study of Gattex (teduglutide), a novel analog of glucagon-like peptide 2, has been published online in the peer-reviewed journal, Gastroenterology, the official journal of the American Gastroenterological Association. The 24-week study, known as STEPS, shows that Gattex is effective and well-tolerated in reducing parenteral support volume and number of infusion days in short bowel syndrome-intestinal failure (SBS-IF) patients.

Researchers performed a 24-week study of patients with SBS-IF who were given either daily subcutaneous dosing of 0.05 mg/kg teduglutide (n=43) or placebo (n=43). Parenteral support (PS) was reduced if 48-hour urine volumes exceeded baseline values by 10 percent. The primary efficacy endpoint was defined as the number of patients who achieved a 20 to 100 percent reduction in weekly PS volume, from baseline, at Weeks 20 and 24.

There were significantly more responders in the teduglutide group (27 of 43) than the placebo group (13 of 43, p=.002). At Week 24, patients who received teduglutide experienced an average 4.4 liter reduction in weekly PS volume from a baseline of 12.9 liters. Patients who received placebo experienced an average 2.3 liter reduction from a baseline of 13.2 liters (p<.001).

After completing 24 weeks of treatment, 54 percent (21 of 39) of teduglutide-treated patients were able to reduce the number of infusion days per week by one or more days, compared to 23 percent (9 of 39) of those treated with placebo (p=0.005).

The distribution of treatment-emergent adverse events that led to study discontinuation was similar between patients given teduglutide (n=2) or placebo (n=3). The most commonly reported adverse events were gastrointestinal-related and appear to be consistent with the pharmacological effects of the drug.


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Theravance Inc. (NASDAQ: THRX)
announced a favorable outcome of the Anti-Infective Drugs Advisory Committee (AIDAC) of the U.S. FDA meeting on VIBATIV(R) (telavancin) for the treatment of nosocomial pneumonia (NP) due to susceptible isolates of Gram-positive microorganisms.



Also Thursday:



Alimera Sciences, Inc. (NASDAQ: ALIM)
(Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Amarantus Bioscience, Inc. (OTCQB: AMBS)
, a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centered on its proprietary anti-apoptosis therapeutic protein MANF, today announced that an independent peer-reviewed research paper entitled Upregulation of mesencephalic astrocyte-derived neurotrophic factor in glial cells is associated with ischemia-induced glial activation was published in the Journal of Neuroinflammation.

Applied DNA Sciences, Inc. (OTCBB: APDN)
, (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions, announced today that it has entered into a Securities Purchase Agreement (the "Agreement") with an institutional accredited investor, Crede CG II, Ltd., to provide a minimum of $7.5 Million in financing.

Atossa Genetics, Inc. (NASDAQ: ATOS)
announced today that Dr. Steven C. Quay, M.D., Ph.D., FCAP, chairman, CEO and president of Atossa Genetics, Inc., will present at the 5th Annual LD Micro Conference on Wednesday, December 5, 2012, at 10:00 AM Pacific Time, at the Luxe Sunset Bel Air Hotel in Los Angeles, California.

BioTime, Inc. (NYSE MKT: BTX)
, a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer Michael D. West, Ph.D. will present at the World Stem Cell Summit 2012 in West Palm Beach, Florida on Tuesday, December 4, 2012.

BrainStorm Cell Therapeutics Inc. (OTC:BCLI)
, a leading developer of adult stem cell technologies and therapeutics, announced today that its senior management will hold a conference call on Tuesday, December 11, 2012 at 8:00 a.m. EST in Hebrew and at 8:45 a.m. EST in English.

Cambrex Corporation (NYSE: CBM)
announced that Shlomo Yanai was appointed to its Board of Directors yesterday and will serve as its Non-Executive Vice Chairman.

Cytomedix, Inc. (OTCQX: CMXI)
(the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today it has received CE Mark approval for the Angel® Concentrated Platelet Rich Plasma (cPRP) System for processing blood and bone marrow aspirate.

DARA BioSciences, Inc. (NASDAQ: DARA)
, a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today it has submitted an Orphan Drug Application to the U.S. Food and Drug Administration (FDA) for KRN5500, a compound in development to treat a painful form of chronic chemotherapy-induced peripheral neuropathy (CCIPN).

Daxor Corporation (NYSE MKT: DXR)
, an investment company with medical instrumentation and biotechnology operations, announced the payment of a dividend today.

Echo Therapeutics, Inc. (Nasdaq: ECTE)
, a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced that it has withdrawn the previously announced proposed underwritten public offering of its common stock due to market conditions.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, announced today that The Edwards Lifesciences Fund is expected to grant nearly $5 million to approximately 250 non-profit organizations around the world in 2012.

GeoVax Labs, Inc. (OTCQB: GOVX)
, an Atlanta-based biopharmaceutical firm developing vaccines to prevent and fight Human Immunodeficiency Virus (HIV) infections, announced that Robert T. McNally, Ph.D., President and CEO, will present at the fifth annual LD Micro Conference on Wednesday, December 5, 2012, at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

Ingen Technologies, Inc. (PINKSHEETS: IGNT)
, an emerging medical device manufacturer with patented proprietary medical technology for the growing $4-Billion Respiratory Industry is pleased to announce that the Company's Smart Nasal Cannula product has been approved and endorsed by the world-renowned Chronic Obstructive Pulmonary Disease (COPD) Alert Support and Advocacy Group.

InSite Vision Incorporated (OTCBB: INSV)
today announced that patient enrollment has been completed in the first Phase 3 clinical trial of BromSite™ (ISV-303) for the reduction of pain and inflammation after cataract surgery.

NPS Pharmaceuticals, Inc. (NASDAQ: NPSP)
, a biopharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, announced today that its Phase 3 study of Gattex (teduglutide), a novel analog of glucagon-like peptide 2, has been published online in the peer-reviewed journal, Gastroenterology, the official journal of the American Gastroenterological Association.

Saint Mary's Healthcare, the first hospital in New York State to achieve the "Pathway to Excellence" Designation from the American Nurses Credentialing Center, and Masimo (NASDAQ: MASI) today jointly announce that Saint Mary's has standardized to Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry, the standard-of-care at leading hospitals worldwide.

Persistent Systems (BSE: PERSISTENT) (NSE: PERSISTENT)
, the global leader in software product and technology services, and Voltage Security®, the world leader in data-centric security and key management, today announced an innovative arrangement that greatly accelerates the process through which 1,000 enterprise users of Voltage SecureData™ data protection solution will receive product releases and patches.

Protalex, Inc. (OTCBB:PRTX)
, a clinical stage biopharmaceutical company, today announced enrollment and dosing of the first patient in the U.S. for its new multicenter Phase 1b randomized, multiple-dose, dose-escalation study of PRTX-100 in adults with active rheumatoid arthritis (RA).

pSivida Corp. (NASDAQ: PSDV) (ASX: PVA)
, a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
today announced that it was named "Biotechnology Company of the Year" by Scrip Intelligence at the 8th annual Scrip Awards.

SmartMetric, Inc. (OTCQB: SMME)
-- Speaking today from London, The President and CEO of SmartMetric, Inc. Ms. Chaya C. Hendrick said SmartMetric's Fingerprint Biometrics Portable Electronic Medical Records is the Safest and Most Secure Method of Storing a person's Medical Records while also ensuring ease of access when and wherever needed.

VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF)
announces that it has filed its financial statements and related management's discussion and analysis, for its third quarter ended September 30, 2012.



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