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Chelsea Therapeutics announces new investigator to conduct phase II clinical study of Droxidopa

Chelsea Therapeutics International, Ltd. announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, has been initiated in chronic fatigue syndrome (CFS).

20 Aug 2010

FDA grants Acceleron's ACE-031 orphan designation for treatment of DMD

Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced the United States Food and Drug Administration (FDA) granted orphan designation for ACE-031 for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease in which patients experience a progressive loss of muscle mass and strength. ACE-031 is an investigational protein therapeutic being developed to increase muscle mass and strength.

20 Aug 2010

Advaxis completes low dose group patient dosing in phase II cervical dysplasia clinical trial study

Advaxis, Inc.,the live, attenuated Listeria monocytogenes (Listeria) immunotherapy company, has completed the nine (9) doses to be administered to the three (3) vanguard patients in the low dose group of its phase II cervical dysplasia clinical trial study.

19 Aug 2010

FDA grants orphan drug designation to ImmunoGen's lorvotuzumab mertansine for small-cell lung cancer

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its lorvotuzumab mertansine (formerly IMGN901) product candidate when used for the treatment of small-cell lung cancer (SCLC).

19 Aug 2010

Bolder BioTechnology receives $600,000 NIH SBIR grant to study long-acting IL-11 analog in ARS

Bolder BioTechnology, Inc. today announced that it has been awarded a Phase I Small Business Innovation Research (SBIR) grant totaling $600,000 from the National Institute of Allergy and Infectious Diseases (NIAID) of The National Institutes of Health (NIH). The grant will be used to demonstrate the feasibility of using our novel, long-acting IL-11 analog to accelerate platelet recovery and improve survival in a mouse model of Acute Radiation Syndrome (ARS).

18 Aug 2010

Rush University Medical Center tests new drug therapy for West Nile fever

Neurological and infectious disease experts at Rush University Medical Center are testing a new drug therapy for the treatment of individuals with West Nile fever or suspected central nervous system infection due to the West Nile virus. Rush is the only site in the Midwest enrolling patients into the $50 million dollar, NIH-funded, Phase II clinical trial called PARADIGM.

18 Aug 2010

Intellect Neurosciences locks database of OXIGON Phase 1b clinical trial for Alzheimer's disease

Intellect Neurosciences, Inc. a biopharmaceutical company with an internal preclinical and clinical-stage pipeline and licenses with major pharmaceutical companies covering products in late-stage clinical trials, announced that it has locked the database of the Company's Phase 1b clinical trial for its lead Alzheimer's candidate, OXIGON™ (OX1).

18 Aug 2010

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Biogen Idec and Knopp Neurosciences today announced they have entered into an exclusive, worldwide license agreement under which Biogen Idec will develop and commercialize KNS-760704 (dexpramipexole) for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, and potentially other indications.

18 Aug 2010

Quark enters licensing option agreement with Novartis for p53 temporary inhibitor siRNA drug QPI-1002

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that it has granted Novartis an option to obtain an exclusive worldwide license to develop and commercialize its p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase II clinical trial.

18 Aug 2010

Repros Therapeutics requests Type B Meeting to review Androxal Phase III protocols

Repros Therapeutics Inc. today announced that the Company has requested a Type B Meeting in order to review the Company's Phase III protocols for Androxal in the treatment of secondary hypogonadism. Androxal is an oral drug that normalizes both testosterone and sperm levels.

18 Aug 2010

USPTO grants Neogenix Oncology patent for DNAs encoding novel molecular aspects of NPC-1 antibody

Neogenix Oncology, Inc. announced today that the U.S. Patent and Trademark Office (USPTO) has issued Patent No. 7,763,720, with claims related to DNAs encoding the novel molecular aspects of the Company's NPC-1 antibody.

18 Aug 2010

AMT's MAA for LPLD gene therapy product Glybera on schedule

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, today announced that the Marketing Authorisation Application (MAA) for Glybera(R) remains on schedule following meetings with the European Medicine Agency (EMA) concerning the Day 120 List of Questions. The company is confident that Glybera(R), a gene therapy product for lipoprotein lipase deficiency (LPLD), remains on track for a regulatory decision by mid-2011.

18 Aug 2010

Lilly to halt development of potential Alzheimer's disease drug semagacestat

Eli Lilly and Company will halt development of semagacestat, a gamma secretase inhibitor being studied as a potential treatment for Alzheimer's disease, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.

18 Aug 2010

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

Researchers from this international study found that patients with chronic hepatitis B virus (HBV) infection who received at least 3 years of cumulative entecavir (antiviral) therapy achieved substantial histologic improvement and regression of fibrosis or cirrhosis. Full details of the study appear in the September issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases (AASLD).

18 Aug 2010

BioMarin commences Phase 3b study of Kuvan's neuropsychiatric effects in phenylketonuria patients

BioMarin Pharmaceutical Inc. announced today that the first subject has initiated treatment in a Phase 3b study (PKU-016) to evaluate the effects of Kuvan (sapropterin dihydrochloride) on neuropsychiatric symptoms in subjects with phenylketonuria (PKU). BioMarin expects to report results in the first half of 2012.

18 Aug 2010

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

Palatin Technologies, Inc. today announced positive results of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without sustained clinically significant blood pressure effects and support the continued development of bremelanotide.

17 Aug 2010

Xenon Pharmaceuticals commences phase 2 clinical trial of XEN402 therapy for PHN

Xenon Pharmaceuticals Inc. announced today that it has initiated a phase 2 clinical trial evaluating its novel topical XEN402 therapy for the treatment of PHN.

17 Aug 2010

Hospitals save $284 million through Premier's Quality Connect quality improvement program

Hospitals participating in a Premier healthcare alliance quality improvement program have saved more than $284 million over the past year through improvements in clinical performance and enhancements in professional practice evaluation.

17 Aug 2010

Intercell reports significant increase in second quarter revenue

Today, Intercell AG announced its financial results for Q2 and H1 2010.IXIARO/JESPECT sales increased significantly from EUR 2.4m in Q2 2009 to EUR 5.2m in Q2 2010 Continued focus on growing marketing and sales of product in traveler and military markets

17 Aug 2010

Key scientific work in Cardio3 BioSciences' C-Cure stem cell heart failure treatment published in JACC

Cardio3 BioSciences, a leading Belgian biotechnology company specialising in regenerative therapies for the treatment of cardiovascular disease, today announces that the key scientific work underlying its lead pharmaceutical product C-Cure(R), a revolutionary stem cell treatment for heart failure, has been published in the Journal of the American College of Cardiology (JACC). The findings were described as "landmark work" in the accompanying editorial in today's publication.

17 Aug 2010

Drug Trial News

Chelsea Therapeutics announces new investigator to conduct phase II clinical study of Droxidopa

FDA grants Acceleron's ACE-031 orphan designation for treatment of DMD

Advaxis completes low dose group patient dosing in phase II cervical dysplasia clinical trial study

FDA grants orphan drug designation to ImmunoGen's lorvotuzumab mertansine for small-cell lung cancer

Bolder BioTechnology receives $600,000 NIH SBIR grant to study long-acting IL-11 analog in ARS

Rush University Medical Center tests new drug therapy for West Nile fever

Intellect Neurosciences locks database of OXIGON Phase 1b clinical trial for Alzheimer's disease

Biogen Idec, Knopp Neurosciences enter license agreement for KNS-760704 ALS drug candidate

Quark enters licensing option agreement with Novartis for p53 temporary inhibitor siRNA drug QPI-1002

Repros Therapeutics requests Type B Meeting to review Androxal Phase III protocols

USPTO grants Neogenix Oncology patent for DNAs encoding novel molecular aspects of NPC-1 antibody

AMT's MAA for LPLD gene therapy product Glybera on schedule

Lilly to halt development of potential Alzheimer's disease drug semagacestat

Long-term entecavir therapy suppresses HBV DNA, normalizes ALT and improves liver histology

BioMarin commences Phase 3b study of Kuvan's neuropsychiatric effects in phenylketonuria patients

Palatin reports positive results from bremelanotide Phase 1 trial for sexual dysfunction

Xenon Pharmaceuticals commences phase 2 clinical trial of XEN402 therapy for PHN

Hospitals save $284 million through Premier's Quality Connect quality improvement program

Intercell reports significant increase in second quarter revenue

Key scientific work in Cardio3 BioSciences' C-Cure stem cell heart failure treatment published in JACC

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