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Phase IIa clinical data of EHT 0202 released

Top-line Phase IIa clinical data released today demonstrate that EHT 0202, ExonHit’s lead candidate for the treatment of Alzheimer’s disease, is safe and generally well tolerated in patients and that it could potentially enhance cognition in Alzheimer’s disease patients.

14 Sep 2009

Clinical data emphasizing on efficacy and potency of torezolid to be presented

Trius Therapeutics, Inc. announced today that 13 posters will be presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) supporting the potency, efficacy and safety of torezolid as a potential new antibiotic for the treatment of severe skin infections caused by gram positive bacteria including MRSA.

14 Sep 2009

Phase III clinical trial results of DAR-31 published

Gilead Sciences, Inc. today announced the publication of data from DAR-311 (DORADO), a Phase III clinical trial evaluating the company’s once-daily oral endothelin receptor antagonist (ERA) darusentan as an add-on treatment for resistant hypertension, defined as the failure to achieve blood pressure goal while adhering to full doses of an appropriate three (or more) drug antihypertensive regimen that includes a diuretic.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Quest Diagnostics' OVA1 ovarian cancer test cleared by the FDA

The U.S. Food and Drug Administration (FDA) today cleared the OVA1(TM) Test, the first blood test that, prior to surgery, can help physicians determine if a woman is at risk for a malignant pelvic mass. OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy.

From Quest Diagnostics 14 Sep 2009

FOCUS 1 and FOCUS 2 clinical trial results released

Forest Laboratories, Inc today presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients.

14 Sep 2009

NIAID conducts human clinical trials of 2009 H1N1 influenza vaccines

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, also is conducting clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials are testing two different dosages (15 micrograms versus 30 micrograms) and evaluating the immune response to one and two doses of these vaccines.

14 Sep 2009

Oral NKTR-118 has low risk for mediating significant drug-drug interactions

Nektar Therapeutics presented clinical study data today demonstrating that the oral tablet formulation of NKTR-118 has favorable systemic bioavailability and a low risk for mediating significant drug-drug interactions.

14 Sep 2009

Phase 2 MS clinical trial data continues to show durable reductions in relapse rate

Genzyme Corporation reported today that four-year follow-up data from its completed Phase 2 multiple sclerosis (MS) trial continued to show durable reductions in relapse rate and sustained accumulation of disability three years after the majority of patients received their last course of the investigational compound alemtuzumab.

14 Sep 2009

U.S., Australian researchers say single H1N1 vaccine dose protects adults against virus

The results of clinical trials have shown one dose of the H1N1 (swine) flu vaccine is enough to offer adults protection against the virus, U.S. and Australian researchers said Thursday, the Associated Press reports (Neergaard, 9/11).

11 Sep 2009

Stem Cell Therapy International to merge with Histostem Korea

Stem Cell Therapy International Inc. (OTCBB: SCII) announced today that the Company has agreed to be a party to the settlement between Histostem, Incorporated, a Delaware Corporation ("Histostem USA") and Histostem Corporation, a Korean Corporation ("Histostem Korea"). The agreement is contingent upon the close of the SCII and Histostem Korea merger, and specifically, the agreement is contingent that at the close of the merger, SCII will acquire no less than 90% of the total fully diluted equity of Histostem Korea.

11 Sep 2009

Delcath Systems to continue Phase III clinical trial

Delcath Systems, Inc., a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced that the Data and Safety Monitoring Board ("DSMB") reviewed clinical data on 77 patients enrolled in its pivotal Phase III clinical trial and unanimously recommended that the trial continue to enroll patients with the goal of reaching the 92 patients required to complete the study.

11 Sep 2009

Pluristem begins enrollment following FDA approval for clinical trials of its PLX-PAD stem cell product

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company’s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).

11 Sep 2009

First patient enrolled in Phase 2b RADAR clinical trial

Regado Biosciences, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, announced that on September 8, 2009 enrollment of the first patient in a Phase 2b, randomized, partially-blinded, multi-center, active-controlled, dose-ranging study of its lead product candidate, the REG1 anticoagulation system (REG1) was achieved.

11 Sep 2009

BioOhio and GCIC launch Ohio Bioscience Resource Directory

BioOhio and the Global Cardiovascular Innovation Center (GCIC) have launched an expanded and improved Ohio Bioscience Resource Directory, the most comprehensive online collection of Ohio companies, organizations, and research centers involved in the biosciences.

11 Sep 2009

Phase 3 trial results of LEVADEX orally inhaled migraine therapy to be presented

MAP Pharmaceuticals, Inc. announced today that it will present analysis of data from the efficacy portion of the first Phase 3 trial of its novel LEVADEX orally inhaled migraine therapy, currently in development, at the 14th Congress of the International Headache Society.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Positive results from Mpex' Phase 2b clinical trial with Aeroquin

Mpex Pharmaceuticals, Inc. today announced positive data from its Phase 2b clinical trial with Aeroquin((R)) (a novel aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF). Trial results showed that nebulized Aeroquin met the primary endpoint of reducing bacterial counts of Pseudomonas aeruginosa (P. aeruginosa) in sputum after 28 days of dosing versus placebo.

11 Sep 2009

Phase 3 trial of ataluren commences

PTC Therapeutics, Inc. (PTC) today announced the initiation of a Phase 3 trial of ataluren (formerly PTC124(R)), an investigational protein restoration therapy in patients with nonsense mutation cystic fibrosis (nmCF).

11 Sep 2009

Phase II clinical trial of TAK-700 for treating advanced prostate cancer commences

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary Millennium: The Takeda Oncology Company today announced the initiation of the Phase II portion of a Phase I/II clinical trial of TAK-700 in patients with advanced prostate cancer.

11 Sep 2009