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Phase II ALSTAR trial: Talampanel is safe for ALS patients

Teva Pharmaceutical Industries Ltd. today announced results from the Phase II ALSTAR trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in Amyotrophic Lateral Sclerosis patients.

18 May 2010

UMPIRE trial of Red Heart Pill launched to combat cardiovascular problems

Researchers will be exploring whether a new, very low cost, one-a-day combined 'polypill' could reduce the risk of heart attacks, strokes and other cardiovascular problems across the world, in a major new international trial that launches today.

18 May 2010

FibroGen's FG-3019 human monoclonal antibody against CTGF reverses progression of lung fibrosis

FibroGen, Inc. today announced that administration of investigational therapy FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), reversed the process of fibrosis in a preclinical model of radiation-induced lung fibrosis, a finding that has implications for treating multiple types of fibrotic disease.

18 May 2010

BaroFold licenses PreEMT Technology to Nuron Biotech for development of BaroFeron

BaroFold, Inc. today announced that it has entered into an agreement to exclusively license its PreEMT™ Technology to Nuron Biotech for the development of BaroFeron™ and follow-on interferon beta products. BaroFeron is a proprietary recombinant human interferon beta being developed for the treatment of multiple sclerosis. Specific terms of the agreement are not disclosed.

17 May 2010

Mpex Pharmaceuticals presents Phase 2b trial results of Aeroquin for cystic fibrosis at ATS Annual Meeting

Mpex Pharmaceuticals, Inc. today announced the presentation of data from its Phase 2b clinical trial with Aeroquin™ (a proprietary aerosol formulation of levofloxacin, MP-376) in cystic fibrosis (CF) at the American Thoracic Society (ATS) Annual Meeting in New Orleans.

17 May 2010

FDA grants NeoPharm's IL13-PE38QQR orphan-drug designation for treatment of IPF

NeoPharm, Inc., announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted orphan-drug designation for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

17 May 2010

Argos Therapeutics presents AGS-004 autologous dendritic cell therapy Phase 2a trial data at 19th CAHR

Argos Therapeutics today announced the presentation of data from the Phase 2a trial of AGS-004, demonstrating that the personalized immunotherapy has a positive impact on the genetic diversity of residual HIV virus, and also results in substantially increased time to viral rebound in HIV patients treated with AGS-004 following antiretroviral therapy (ART) interruption.

17 May 2010

Hemispherx Biopharma to conduct study of Ampligen antiviral in China

As part of its expanding international program Hemispherx Biopharma, Inc., announced an agreement with Fountain Medical Development Ltd., a leading Chinese clinical research organization (CRO) to prepare, file and gain approval from the authorities in China to conduct a study of Ampligen, an investigational therapeutic.

17 May 2010

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

ARCA biopharma, Inc. today announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a clinical trial to assess the safety and efficacy of bucindolol in approximately 3,200 patients with chronic heart failure who have the genotype that appears to respond most favorably to bucindolol. Bucindolol is the Company's investigational, pharmacologically unique, beta-blocker and mild vasodilator.

17 May 2010

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Emergent BioSolutions Inc. announced today that its Investigational New Drug (IND) application, to commence a Phase I clinical trial for its anthrax monoclonal antibody therapeutic, has cleared U.S. Food and Drug Administration (FDA) review. The Phase I study will evaluate the safety and pharmacokinetics of the company's fully human monoclonal antibody being developed as a parenteral post-exposure therapy for individuals who have symptoms of anthrax disease. In pre-clinical therapeutic studies, Emergent's monoclonal antibody was found to be effective.

17 May 2010

Celldex Therapeutics commences screening in CDX-1307 Phase 2 study for bladder cancer

Celldex Therapeutics, Inc. today announced that the first patient has been screened in a randomized Phase 2 study of the Company's novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta.

17 May 2010

Tranzyme Pharma to present data on prokinetic agent TZP-101 in GI recovery at ASCRS 2010

Tranzyme Pharma today announced that Philippa Charlton, MD, Tranzyme's Medical Director, and her colleagues G. Bochicchio, J.C. Pezullo, G. Kosutic, and A. Senagore, will present a poster entitled "The Prokinetic Agent TZP-101 (a Ghrelin Agonist) Accelerates GI Recovery in Partial Colectomy Patients Independently of Total Opioid Use and Type of Surgery" at the upcoming 2010 Annual Scientific Meeting of the American Society of Colon and Rectal Surgeons (ASCRS; Minneapolis, May 15-19).

17 May 2010

Polypill to be tested in new heart disease trial

17 May 2010

Roche to commence clinical study of TB-403 in patients with colorectal and ovarian cancer

BioInvent International AB and ThromboGenics NV announce today that their partner Roche will begin an imaging study with the novel anti-cancer antibody TB-403 (RG7334) in patients with metastatic, treatment-refractory, colorectal and ovarian cancer.

17 May 2010

Treatment with MP-376 reduces P. aeruginosa in CF patients: Research

A new possible treatment to treat P. aeruginosa in cystic fibrosis patients appears to be promising, according to research to be presented at the ATS 2010 International Conference in New Orleans.

17 May 2010

Inhibitex commences trials on INX-189 for treatment of Hepatitis C infections

The first clinical trials have started on a new investigational drug, discovered by researchers at Cardiff University, which is being developed to treat infections caused by Hepatitis C virus.

15 May 2010

Merck, Cardiome Pharma show superiority of BRINAVESS to amiodarone injection

In a new Phase III study, BRINAVESSTM (vernakalant) intravenous, an investigational compound being developed in the European Union by Merck (known as MSD outside the USA and Canada) and Cardiome Pharma Corp. to treat atrial fibrillation, showed that BRINAVESS was superior to amiodarone injection, in converting patients' heart rate from atrial fibrillation (AF) to sinus rhythm (SR) within 90 minutes of the start of administration.

15 May 2010

Data from RGN-259 study published in Archives of Ophthalmology

RegeneRx Biopharmaceuticals, Inc. announced today the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal.

14 May 2010

Phase 2a study results of Aerosurf for prevention of RDS in premature infants published

Discovery Laboratories, Inc., announces the publication of results from its previously-conducted Phase 2a feasibility study of Aerosurf, the Company's aerosolized KL4 surfactant, for the prevention of respiratory distress syndrome in premature infants, in the May 2010 issue of the Journal of Aerosol Medicine and Pulmonary Drug Delivery in the study titled "An Open Label, Pilot Study of Aerosurf Combined with nCPAP to Prevent RDS in Preterm Neonates".

14 May 2010

Inhibitex reports net loss of $4.8M for first-quarter 2010

Inhibitex, Inc. today announced its financial results for the first quarter ended March 31, 2010. The Company also announced that it has initiated a Phase I single ascending dose trial of INX-189, its lead HCV nucleotide polymerase inhibitor, in healthy volunteers under an Investigational New Drug application with the U.S. Food and Drug Administration.

14 May 2010

Drug Trial News

Phase II ALSTAR trial: Talampanel is safe for ALS patients

UMPIRE trial of Red Heart Pill launched to combat cardiovascular problems

FibroGen's FG-3019 human monoclonal antibody against CTGF reverses progression of lung fibrosis

BaroFold licenses PreEMT Technology to Nuron Biotech for development of BaroFeron

Mpex Pharmaceuticals presents Phase 2b trial results of Aeroquin for cystic fibrosis at ATS Annual Meeting

FDA grants NeoPharm's IL13-PE38QQR orphan-drug designation for treatment of IPF

Argos Therapeutics presents AGS-004 autologous dendritic cell therapy Phase 2a trial data at 19th CAHR

Hemispherx Biopharma to conduct study of Ampligen antiviral in China

ARCA biopharma announces SPA agreement with FDA for bucindolol clinical trial

Emergent BioSolutions' anthrax monoclonal antibody IND for Phase I study clears FDA review

Celldex Therapeutics commences screening in CDX-1307 Phase 2 study for bladder cancer

Tranzyme Pharma to present data on prokinetic agent TZP-101 in GI recovery at ASCRS 2010

Polypill to be tested in new heart disease trial

Roche to commence clinical study of TB-403 in patients with colorectal and ovarian cancer

Treatment with MP-376 reduces P. aeruginosa in CF patients: Research

Inhibitex commences trials on INX-189 for treatment of Hepatitis C infections

Merck, Cardiome Pharma show superiority of BRINAVESS to amiodarone injection

Data from RGN-259 study published in Archives of Ophthalmology

Phase 2a study results of Aerosurf for prevention of RDS in premature infants published

Inhibitex reports net loss of $4.8M for first-quarter 2010

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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