NeurogesX Receives FDA Acceptance for Review of sNDA for Qutenza 8% Patch; Positive Results from POZEN Phase 1 Study Print E-mail
By Staff and Wire Reports   
Monday, 14 November 2011 21:09
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 14, 2011.

NeurogesX, Inc. (Nasdaq: NGSX) announced the U.S. Food and Drug Administration has accepted for review the Company's supplemental new drug application for Qutenza 8% for the management of neuropathic pain associated with HIV-associated peripheral neuropathy.

The FDA has granted Qutenza a priority six month review classification, assigning a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2012.

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POZEN Inc. (NASDAQ: POZN), presented positive results from a Phase 1 study comparing a dose-timing strategy of PA32540 and clopidogrel spaced 10 hours apart as compared to synchronous administration of enteric-coated omeprazole, enteric-coated aspirin and clopidogrel .

In the Co-Rx study, PA32540, a novel combination of 325 mg of aspirin and 40 mg immediate-release omeprazole, when dosed 10 hours apart from clopidogrel, was associated with greater platelet inhibition than synchronous administration of aspirin, clopidogrel and delayed-release omeprazole (46.5% versus 39.3%), respectively, at day 7.

These findings are directly relevant to the treatment of patients with gastrointestinal (GI) risk who require dual antiplatelet therapy and gastroprotection. The data was presented at the American Heart Association's 2011 Scientific Sessions in Orlando, Florida.



Also Monday:



AdCare Health Systems, Inc.(NYSE Amex: ADK)
, a leading nursing home and assisted living company, has been invited to present at the Southwest IDEAS Investor Conference.

Amgen (NASDAQ: AMGN)
today issued the following statement:  Amgen will be meeting with investors in Europe this week with a view to raise $1-1.5 billion in Euro and Sterling denominated debt to support its share repurchase program, as well as for general corporate purposes.

Anavex Life Sciences Corp. (OTCBB: AVXL) today announced the successful completion of its Phase 1 single ascending dose (SAD) clinical trial of ANAVEX 2-73, the company's lead drug candidate for the treatment of Alzheimer's Disease (AD).

Arrhythmia Research Technology, Inc. (NYSE Amex: HRT) and its subsidiaries reported total revenue of $6,789,000 and net loss of $74,000 for the three months ended September 30, 2011 compared to total revenue of $5,888,000 and net income of $120,000 for the same quarter of 2010.

BioMed Realty Trust, Inc. (NYSE: BMR) today announced that the public offering price for the 22,562,922 shares of its common stock previously sold to UBS Investment Bank, the sole underwriter for the offering, is $17.92 per share, for expected gross proceeds of approximately $404.3 million, before underwriting discounts and estimated expenses.

BioTime, Inc. (NYSE Amex: BTX) and XenneX, Inc. today announced the inclusion of cell identification data in GeneCards® 3.07 available at www.genecards.org.

Cisco (NASDAQ: CSCO) announced the general availability of the newest version of Cisco HealthPresence® technology, an advanced care-at-a-distance platform that connects patients and clinicians via high-definition video, audio, medical devices and collaboration tools.

CNS Response, Inc. (OTCBB: CNSO) today announced that Poster 106, featured at the 2011 NEI Global Psychopharmacology Congress, highlights the use of PEER Online™ to assist physicians in reducing trial and error medication selection and avoiding possible severe adverse events from medications for non-psychotic patients.

Corporate Profile's financial website, www.CPreports.com, announces Ray Dirks' update on Pluristem Therapeutics, Inc. (NASDAQ: PSTI).

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), reports today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (LEMTRADA™) as compared with Rebif® (44 mcg subcutaneous interferon beta-1a).

Kraig Biocraft Laboratories, Inc. (OTCQB: KBLB.PK) (Pinksheets: KBLB.PK)  announced that researchers at the University of Notre Dame, utilizing customized zinc finger configurations licensed to Kraig from Sigma-Aldrich, succeeded in creating seven or more strains of transgenically modified silkworms.

Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that two posters highlighting potential cost savings based on observations from previous clinical trials of Zerenex™ (ferric citrate) were presented by DaVita Clinical Research this past weekend during the American Society of Nephrology (ASN) Kidney Week 2011 Annual Meeting and Exposition in Philadelphia.

Luminex Corporation (NASDAQ: LMNX)
today announced Dr. Amy Altman, vice president of Biodefense will present at the Defense Threat Reduction Agency's (DTRA) 2011 Chemical and Biological Defense Science and Technology (CBD S&T) Conference, which takes place November 14-16, 2011 in Las Vegas, Nevada.

Neuralstem, Inc. (NYSE Amex: CUR) announced that the ongoing Phase I trial to test its spinal cord stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease) was featured Wednesday night on Fox 5 News in Atlanta  http://www.neuralstem.com/neuralstem-in-the-news

Nile Therapeutics, Inc. (OTCQB: NLTX), a biopharmaceutical company that develops novel therapeutics for heart failure patients, today announced its third quarter financial results for 2011.

Oncolytics Biotech Inc. (TSX:ONC, NASDAQ: ONCY) today announced that positive results from a Phase 2 clinical trial (REO 015) using intravenous administration of REOLYSIN® in combination with paclitaxel and carboplatin in patients with advanced head and neck cancers will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

Origin Agritech Limited (NASDAQ:SEED) (“Origin” or the “Company”), a technology-focused supplier of crop seeds and agricultural products in China, today announced that Dr. James Chen will join Origin’s executive management team as the Chief Financial Officer.

Positron Corporation (OTCBB:POSC.OB), a leading molecular imaging company specializing in the field of nuclear cardiology is pleased to announce today that on Friday November 11, 2011, Positron and Manhattan Isotope Technology LLC. (MIT LLC) entered into a binding Letter of Intent to acquire MIT LLC. The transaction will close January 2, 2012 upon execution of final transaction documents.

Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that it will host an Investor and Analyst Day at NASDAQ Tower in New York on Monday, November 14, 2011 from 2:00 to 5:00 pm ET.

Soligenix, Inc. (OTCBB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today its financial results for the third quarter of 2011.

Transgenomic, Inc.(OTCBB: TBIO) today announced the launch of two innovative genetic tests at the annual meeting of the American Heart Association in Orlando, Florida.

Unigene Laboratories, Inc. (OTCBB: UGNE)
, a leader in the design, delivery, manufacture and development of peptide-based therapeutics, today announced that Novartis Pharma AG ("Novartis") has disclosed to Unigene its first interpretable results from a three-year Phase 3 trial, Study 2303, conducted by its license partner Nordic Bioscience, assessing the safety and efficacy of an oral formulation of calcitonin (SMC021), which used Emisphere’s proprietary oral delivery technology, in the treatment of post-menopausal osteoporosis.

Unilens Vision Inc. (OTCBB: UVIC) (OTCQB: UVIC) (TSX-V: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today reported its operating results for the first quarter of FY2012.

ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company employing small molecule and synthetic biology approaches to cancer therapy, announced today promising clinical results from an ongoing multicenter Phase 1b, open-label, dose escalation study of intravenous (IV) palifosfamide (Zymafos® or ZIO-201) in combination with etoposide and carboplatin in patients with small cell lung cancer (SCLC) and other selected cancers.

ZOLL Medical Corporation (NASDAQ GS: ZOLL), a manufacturer of medical devices and related software solutions, announced today that data showing the cost-effectiveness of the LifeVest®Wearable Defibrillator was presented in two scientific presentations and posters at the American Heart Association’s Scientific Sessions 2011 in Orlando over the weekend.



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