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Knopp Neurosciences enters $345 million worldwide licensing agreement with Biogen Idec

A Pittsburgh start-up company that received an early investment from one of Pennsylvania's most dynamic resources has entered into an exclusive licensing agreement to help find the cure for Lou Gehrig's disease, or ALS, Department of Community and Economic Development Secretary Austin Burke announced today.

20 Aug 2010

Trial shows positive results for radioembolisation technique for colorectal cancer liver metastases treatment

Using the innovative technique of radioembolisation to treat patients with inoperable colorectal cancer liver metastases who have failed all standard-of-care chemotherapy options can more than double the time until their disease progresses, according to the final results of a Phase III randomised controlled trial published in the prestigious Journal of Clinical Oncology.

20 Aug 2010

SRI and Taiho collaborate to advance clinical development of TAS-108 breast cancer program

SRI International, an independent nonprofit research and development organization, announced today that it has assumed responsibility for further clinical development of the TAS-108 breast cancer program, in cooperation with Taiho Pharmaceuticals Co., Ltd., a leading Japanese pharmaceutical company. Further clinical development will focus on the lead compound's registration for the treatment of tamoxifen and aromatase inhibitor-resistant breast cancers.

20 Aug 2010

Quark Pharmaceuticals announces option agreement with Novartis for QPI-1002 siRNA drug

Silence Therapeutics plc, a leading international RNAi therapeutics company, is pleased to note that its partner, Quark Pharmaceuticals, Inc., has announced the grant of an option to Novartis to obtain an exclusive worldwide license to develop and commercialise QPI-1002, a p53 temporary inhibitor siRNA drug which incorporates Silence's AtuRNAi technology.

20 Aug 2010

Bioniche provides update on Urocidin clinical development program for non-muscle-invasive bladder cancer

Bioniche Life Sciences Inc., a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin.

20 Aug 2010

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

Drug Trial News

Knopp Neurosciences enters $345 million worldwide licensing agreement with Biogen Idec

Trial shows positive results for radioembolisation technique for colorectal cancer liver metastases treatment

SRI and Taiho collaborate to advance clinical development of TAS-108 breast cancer program

Quark Pharmaceuticals announces option agreement with Novartis for QPI-1002 siRNA drug

Bioniche provides update on Urocidin clinical development program for non-muscle-invasive bladder cancer

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

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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