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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

Shire to present key data on ADHD treatments at national psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, announced today that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV- (guanfacine) Extended Release Tablets, Vyvanse- (lisdexamfetamine dimesylate) Capsules CII, and Daytrana- (methylphenidate transdermal system) CII, at a national meeting of psychiatrists to be held October 27 - November 1 in Honolulu.

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

Schering-Plough receives FDA complete response letter regarding PEGINTRON

Schering-Plough Corp. announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter to the company's supplemental Biologics License Application regarding PEGINTRON® (pegylated interferon alfa-2b) for the adjuvant treatment of patients with stage III malignant melanoma after complete lymphadenectomy.

31 Oct 2009

Quintiles and Eisai partner to develop potential oncology products

Quintiles today announced a strategic alliance with leading global pharmaceutical company Eisai Co., Ltd. (Tokyo, Japan) to develop six potential oncology products in Eisai’s R&D pipeline. Under the terms of the agreement, Quintiles’ oncology experts will conduct Phase II proof-of-concept studies for 11 solid tumor indications. A key goal of the alliance is to determine the efficacy of the products in the shortest possible time in order to bring therapies to market faster for the benefit of cancer patients worldwide.

31 Oct 2009

NovaBay Pharmaceuticals' Aganocide compounds demonstrate potent antifungal activity against onychomycosis

NovaBay Pharmaceuticals, Inc. today announced that its Aganocide® compounds demonstrate potent antifungal activity in an established pre-clinical infected nail model of onychomycosis. The study data will be presented tomorrow at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA) in Philadelphia.

31 Oct 2009

Data from multiple clinical and preclinical studies evaluating Hematide announced

Affymax, Inc. and Takeda Pharmaceutical Global Research & Development Center, Inc., today announced data from multiple clinical and preclinical studies evaluating Hematide, including preliminary results of a Phase 2 trial which demonstrated that Hematide increased hemoglobin levels in a group of anemic hemodialysis (HD) patients.

31 Oct 2009

Bayer HealthCare's Phase II study results of imaging agent florbetaben

Bayer HealthCare presented results from a global Phase II study of florbetaben, its imaging agent in development for the detection of cerebral beta-Amyloid plaques, at the 19th World Congress of Neurology (WCN).

30 Oct 2009

Sunesis Pharmaceuticals enrolls 113 patients in voreloxin REVEAL-1 trial

Sunesis Pharmaceuticals, Inc. today reported that it has completed enrollment in the REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose regimen optimization trial of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard induction chemotherapy. A total of 113 patients were enrolled and dosed according to one of three dosing schedules.

30 Oct 2009

Idenix Pharmaceuticals reports phase I study results of IDX184 for treating HCV

Idenix Pharmaceuticals, Inc.a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced presentations of data on IDX184, a once-daily novel liver-targeted nucleotide prodrug of 2'-methyl guanosine (2'MeG) for the treatment of HCV, at the annual meeting of the American Association for the Study of Liver Diseases (AASLD) currently being held in Boston, Massachusetts.

30 Oct 2009

Updated results from Oncolytics Biotech's Phase II study of REOLYSIN presented at CTOS meeting

Oncolytics Biotech Inc. announced that a poster presentation covering updated results of a Phase II study of REOLYSIN(R) administered intravenously to patients with sarcomas metastatic to the lung will be presented at the 15th Annual Connective Tissue Oncology Society (CTOS) Meeting being held in Miami Beach, Florida on November 6th, 2009.

30 Oct 2009