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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

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

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

Alnylam Pharmaceuticals presents new data from its transthyretin-mediated amyloidosis program

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it presented new pre-clinical research findings from its transthyretin (TTR)-mediated amyloidosis (ATTR) program at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (“The Liver Meeting”).

2 Nov 2009

Vanda Pharmaceuticals announces financial results for the third quarter of 2009

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the third quarter ended September 30, 2009.

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

ACM Global Central Laboratory celebrates landmark anniversary

ACM Global Central Laboratory, the global central lab that continually defines the customer-service standard with its flexible approach, is this week celebrating its 10th anniversary of providing central laboratory services throughout Europe.

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

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

Eli Lilly selects ICON to provide clinical data management outside the US

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it has signed an extension to its strategic agreement with Eli Lilly and Company (NYSE:LLY) to manage the company’s clinical data management outside the US.

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

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

Multicenter study finds AMD patients can benefit from cataract surgery

This month's Ophthalmology, the journal of the American Academy of Ophthalmology (Academy) reports on a national study that finds cataract surgery is likely to benefit patients with age-related macular degeneration (AMD) at all stages of the disease, on a clinical trial showing that the steroid triamcinolone may be effective in advanced diabetic macular edema (DME) patients when standard treatment fails, and on the public's use of two Academy-sponsored online eye health forums.

2 Nov 2009

Shire announces third quarter 2009 financial results

Shire plc, the global specialty biopharmaceutical company, announces results for the three months to September 30, 2009.

31 Oct 2009

Replenish+ delays the progression of AIDS in HIV-infected patients not receiving ART

Data presented today from a 310 patient, 52 week, double-blind, controlled clinical trial demonstrates that a micronutrient supplement, Replenish+™ delays the progression of AIDS in HIV-infected patients not receiving antiretroviral treatment (ART).

31 Oct 2009

Geron plans to advance clinical program for spinal cord injury

Geron Corporation today announced the company’s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury.

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