Efficacy News and Research

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Pico-Tesla commences pilot study of its Resonator system for treating type 2 diabetes patients

Pico-Tesla, The Magneceutical™ Therapy Company, announced today that it has commenced a randomized, double-blind, placebo-controlled Pilot Study of up to 165 persons who have type 2 diabetes, the most common form of diabetes.

2 Nov 2009

Enzo Biochem announces results of EGS21 clinical trial for treatment of non-alcoholic steatohepatitis

Enzo Biochem Inc. announced today that favorable results of the Company’s clinical trial for treatment of non-alcoholic steatohepatitis (NASH) were presented at the annual meeting of the American Association for the Study of Liver Diseases. The study was a randomized double blind placebo controlled format of EGS21, Enzo’s orally administered beta glucosylceramide formulation, designed to evaluate safety and efficacy of the study drug in patients with NASH and its associated metabolic syndrome.

2 Nov 2009

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

Gilead Sciences, Inc., in collaboration with GlaxoSmithKline (GSK), today announced plans for an international, event-driven (morbidity and mortality) clinical trial to study combination therapy versus monotherapy in a first-line treatment setting for pulmonary arterial hypertension (PAH).

2 Nov 2009

FDA issues a Complete Response Letter for GTx' toremifene NDA

GTx, Inc. today announced that it has received a Complete Response Letter issued by the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for toremifene 80 mg to reduce fractures in men with prostate cancer receiving androgen deprivation therapy (ADT).

2 Nov 2009

Juvaris BioTherapeutics commences enrollment in its JVRS-100 influenza vaccine adjuvant study

Juvaris BioTherapeutics, Inc., a biotechnology company developing adjuvanted vaccines for infectious diseases, today announced that it has begun enrolling patients in a Phase 2 clinical trial of its lead compound, JVRS-100, as an adjuvant for seasonal influenza vaccines in the elderly population.

2 Nov 2009

Positive results from Aeterna Zentaris' AEZS-108 Phase 2 study in ovarian cancer patients

AEterna Zentaris Inc., a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with platinum-resistant and taxane-pretreated ovarian cancer.

2 Nov 2009

NIAID awards Pulmatrix $2.2M grant for developing novel influenza therapeutics

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the treatment and prevention of infectious and progressive respiratory diseases, today announced that it has been awarded a grant for $2.2 million from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), aimed at advancing the development of novel influenza therapeutics for the treatment of seasonal and pandemic influenza.

2 Nov 2009

Pulmatrix raises $30.2 million through Series B financing

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the treatment and prevention of infectious and progressive respiratory diseases, today announced that it has secured $30.2 million in Series B financing. ARCH Venture Partners and Novartis Bioventures Fund co-led the round with participation from existing investors Polaris Venture Partners and 5AM Ventures.

2 Nov 2009

Deep brain stimulation can help patients with severe forms of depression

In deep brain stimulation, doctors specifically target the impaired function of certain areas of the brain with an electric brain pacemaker. For the purpose of this study, they implanted electrodes in what is known as the nucleus accumbens. That is an important part of the 'reward system' which ensures that we remember good experiences and puts us in a state of pleasant anticipation.

2 Nov 2009

NOXXON Pharma commences human dosing in Spiegelmer NOX-A12 clinical trial

NOXXON Pharma AG, the biopharmaceutical company focusing on the development of novel drugs based on its unique proprietary Spiegelmer® technology, announced today the successful initial dosing of healthy volunteers in a first-in-human clinical trial with Spiegelmer® NOX-A12. NOX-A12 is NOXXON’s second drug candidate entering the clinical stage of development within only five months.

2 Nov 2009

Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

Bristol-Myers Squibb today announced 48-week data from an ongoing study (ETV-048) of chronic hepatitis B patients with decompensated cirrhosis, in which BARACLUDE demonstrated greater viral suppression compared to adefovir. The new BARACLUDE data were presented today at the 60th Annual Meeting of the American Association for the Study of Liver Diseases.

2 Nov 2009

BMY and ZGen present Phase 1B results for PEG-Interferon lambda in HCV patients

Bristol-Myers Squibb Company and ZymoGenetics, Inc. today presented final results from a Phase 1b clinical trial of PEG-Interferon lambda administered with ribavirin in relapsed and treatment-naïve hepatitis C virus (HCV) patients.

2 Nov 2009

Gilead Sciences to present Viread Phase III clinical trial data

Gilead Sciences, Inc. today announced the presentation of three-year (144-week) open label data from two pivotal Phase III clinical trials, Studies 102 and 103, evaluating the safety and efficacy of once-daily Viread® (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

2 Nov 2009

ExonHit Therapeutics to take part in MAPT study for early detection of Alzheimer’s disease

ExonHit Therapeutics (Paris:ALEHT) together with Toulouse University Hospital and l’Institut de Recherche Pierre Fabre (IRPF) will participate in the Multidomain Alzheimer Preventive Trial (MAPT). The study’s main objective is to assess the efficacy of a multidomain (nutrition, physical exercise, cognitive stimulation) intervention associated with an omega-3 treatment in preventing the decline of cognitive functions in aged and frail individuals.

2 Nov 2009

London Genetics enters an intensive partnering programme

London Genetics Limited, an expert in the use of pharmacogenetics in clinical drug discovery and development, has entered an intensive partnering programme following on from its successful pharmacogenetic conference in September.

31 Oct 2009

Molecular imaging pinpoints inflammation in the brains of schizophrenics and migraine sufferers

Inflammatory response of brain cells-as indicated by a molecular imaging technique-could tell researchers more about why certain neurologic disorders, such as migraine headaches and psychosis in schizophrenic patients, occur and provide insight into how to best treat them, according to two studies published in the November issue of the Journal of Nuclear Medicine.

31 Oct 2009

Shire announces Phase IIIb study results of Daytrana

Shire plc, the global specialty biopharmaceutical company, today announced findings at a major medical meeting from a Phase IIIb study of the tolerability and effectiveness of Daytrana® (methylphenidate transdermal system) in adolescents aged 13 to 17 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD).

31 Oct 2009

New study results of INTUNIV presented at a major psychiatric medical meeting

Shire plc, the global specialty biopharmaceutical company, announced new study results on INTUNIV- (guanfacine) Extended Release Tablets, at a major psychiatric medical meeting today.

31 Oct 2009

Conference to address the need for gender specific diagnostic strategies for women

The 'Red Alert for Women's Hearts' conference, taking place on 5 November 2009, at the European Heart House, Sophia Antipolis, France, will address the subject of Women and CVD. The conference is jointly organised by the European Society of Cardiology (ESC) and European Heart Network (EHN), as part of Work Package 6 of the EuroHeart project .

31 Oct 2009

Four abstracts on RSV and influenza prevention in pediatric health to be presented

MedImmune announced today it will present four abstracts at the 47th Annual Meeting of Infectious Disease Society of America (IDSA) being held here October 29 through November 1, 2009. These abstracts advance the body of data surrounding respiratory syncytial virus (RSV) and influenza prevention, highlighting MedImmune's leadership in pediatric health.

31 Oct 2009

Efficacy News and Research

Pico-Tesla commences pilot study of its Resonator system for treating type 2 diabetes patients

Enzo Biochem announces results of EGS21 clinical trial for treatment of non-alcoholic steatohepatitis

Study of combination therapy versus monotherapy for pulmonary arterial hypertension

FDA issues a Complete Response Letter for GTx' toremifene NDA

Juvaris BioTherapeutics commences enrollment in its JVRS-100 influenza vaccine adjuvant study

Positive results from Aeterna Zentaris' AEZS-108 Phase 2 study in ovarian cancer patients

NIAID awards Pulmatrix $2.2M grant for developing novel influenza therapeutics

Pulmatrix raises $30.2 million through Series B financing

Deep brain stimulation can help patients with severe forms of depression

NOXXON Pharma commences human dosing in Spiegelmer NOX-A12 clinical trial

Interim data from Bristol-Myers Squibb's BARACLUDE study for chronic hepatitis B patients

BMY and ZGen present Phase 1B results for PEG-Interferon lambda in HCV patients

Gilead Sciences to present Viread Phase III clinical trial data

ExonHit Therapeutics to take part in MAPT study for early detection of Alzheimer’s disease

London Genetics enters an intensive partnering programme

Molecular imaging pinpoints inflammation in the brains of schizophrenics and migraine sufferers

Shire announces Phase IIIb study results of Daytrana

New study results of INTUNIV presented at a major psychiatric medical meeting

Conference to address the need for gender specific diagnostic strategies for women

Four abstracts on RSV and influenza prevention in pediatric health to be presented

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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