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Interim data from Schering-Plough's narlaprevir Phase IIa study

Schering-Plough Corporation reported that interim results from an ongoing Phase IIa study of narlaprevir (SCH 900518), its investigational, once-daily protease inhibitor, demonstrated potent antiviral activity in treatment-naive patients with chronic hepatitis C virus (HCV) genotype 1.

3 Nov 2009

NUVIGIL improves wakefulness in patients with excessive sleepiness associated with shift work disorder

Cephalon, Inc. today announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demonstrating that NUVIGIL® (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD).

3 Nov 2009

BioVex publishes OncoVEX (GM-CSF) Phase 2 study results

BioVex Inc, a company developing new generation biologics for the treatment and prevention of cancer and infectious disease, announced today that the data from its completed Phase 2 clinical study of OncoVEX (GM-CSF) for the treatment of advanced melanoma has been published in the Journal of Clinical Oncology (JCO). The previously announced top line results report a high objective durable response rate and a high complete response rate, combined with a relatively benign side effect profile.

2 Nov 2009

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

Dendreon submits an amended BLA for PROVENGE active cellular immunotherapy

Dendreon Corporation today announced that it has completed the submission of the amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T), the Company's lead investigational product, to the U.S. Food and Drug Administration (FDA). Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

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

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

EnzymeRx, LLC (www.enzymerx.com), a clinical-stage biotechnology company, announced that it has launched its first clinical study of Uricase-PEG 20. Subjects have begun enrolling in a phase 1 safety, pharmacokinetic and pharmacodynamic study of single intravenous doses of Uricase-PEG 20.

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

Avila Therapeutics presents preclinical study data of its AVL-181 HCV protease inhibitor

Avila Therapeutics™, Inc., a biotechnology company developing novel covalent drugs that treat diseases through protein silencing, presented results of preclinical studies on its highly selective, small molecule Hepatitis C Virus (HCV) protease inhibitor, AVL-181. Avila showed that AVL-181 promoted complete viral clearance in vitro when used at clinically-relevant concentrations in combination with other HCV therapies.

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

LRI and lupus organizations congratulate HGS and GlaxoSmithKline for achieving historical landmark

The Lupus Research Institute (LRI) and its National Coalition of state and local lupus organizations congratulate Human Genome Sciences (HGS) and GlaxoSmithKline for achieving an historical landmark - the second positive phase 3 clinical trial of Benlysta (belimumab), the first successfully tested new drug developed specifically for people with systemic lupus.

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

HGS and GSK announce results from phase III clinical trials of BENLYSTA

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) today announced positive results from BLISS-76, the second of two large-scale phase III clinical trials of BENLYSTA(TM) (belimumab) for treating systemic lupus. A full presentation of results from BLISS-52 was recently shared at the 73rd Annual Scientific meeting of the American College of Rheumatology. Both trials succeeded in meeting their primary endpoints, which should make BENLYSTA eligible for approval by the U.S. Food and Drug Administration (FDA).

2 Nov 2009

BENLYSTA meets primary endpoint in BLISS-76 trial for systemic lupus erythematosus

Human Genome Sciences, Inc. and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA™ (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE). BLISS-76 study results through 52 weeks showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care.

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

Vertex Pharmaceuticals announces study results of telaprevir-based regimen

More than 80 percent of hepatitis C patients in each arm of the Phase 2 Study C208 achieved a sustained viral response (SVR) with a telaprevir-based regimen according to results of an intent-to-treat (ITT) analysis announced today by Vertex Pharmaceuticals Incorporated.

2 Nov 2009

Optimer Pharmaceuticals presents additional data from Phase 3 fidaxomicin study

Optimer Pharmaceuticals, Inc. today announced the presentation of new data from fidaxomicin's North American phase 3 study at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia, PA.

2 Nov 2009

Amgen publishes Phase 3 study results of Aranesp

Amgen today announced the publication of results from TREAT (the Trial to Reduce Cardiovascular Events with Aranesp® Therapy), a large, randomized, double-blind, placebo-controlled, Phase 3 pivotal study of patients with chronic kidney disease (CKD) not on dialysis, moderate anemia and type-2 diabetes.

31 Oct 2009

Drug Trial News

Interim data from Schering-Plough's narlaprevir Phase IIa study

NUVIGIL improves wakefulness in patients with excessive sleepiness associated with shift work disorder

BioVex publishes OncoVEX (GM-CSF) Phase 2 study results

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

Dendreon submits an amended BLA for PROVENGE active cellular immunotherapy

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

EnzymeRx commences patient enrollment in Uricase-PEG 20 phase 1 study

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

Avila Therapeutics presents preclinical study data of its AVL-181 HCV protease inhibitor

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

LRI and lupus organizations congratulate HGS and GlaxoSmithKline for achieving historical landmark

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

HGS and GSK announce results from phase III clinical trials of BENLYSTA

BENLYSTA meets primary endpoint in BLISS-76 trial for systemic lupus erythematosus

Gilead Sciences to present Viread Phase III clinical trial data

Vertex Pharmaceuticals announces study results of telaprevir-based regimen

Optimer Pharmaceuticals presents additional data from Phase 3 fidaxomicin study

Amgen publishes Phase 3 study results of Aranesp

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