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NOVAVAX completes pre-clinical safety and efficacy study of its RSV vaccine candidate

Novavax, Inc. announced today that it has successfully completed a pre-clinical safety and efficacy study of its RSV vaccine candidate in cotton rats. Results from this study are needed to support an Investigational New Drug (IND) application to advance this novel recombinant F protein particle based RSV (RSV-F) vaccine candidate into clinical development. This vaccine candidate is composed of recombinant 'F' or 'fusion' protein of RSV which is used by the virus to infect and fuse with cells in the respiratory tract and cause disease.

13 Jan 2010

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Spherix Inc., an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the completion of patient enrollment in its global Phase 3 clinical trial NEET (70971-004), which is evaluating the safety and efficacy of D-tagatose as an oral treatment for Type 2 diabetes mellitus.

12 Jan 2010

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

VION PHARMACEUTICALS, INC. announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML). The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

12 Jan 2010

Preliminary results from Nektar Therapeutics' NKTR-102 Phase 2 study in platinum-resistant ovarian cancer

Nektar Therapeutics today announced preliminary results from the first stage of a two-stage Phase 2 clinical study evaluating NKTR-102 in women with platinum-resistant ovarian cancer. In the first stage of the study, 39 patients enrolled with platinum-resistant disease were evaluable for the primary endpoint of overall response rate using Gynecologic Cancer InterGroup (GCIG) criteria, i.e., a combination of response by tumor imaging

12 Jan 2010

VaxInnate grants license to Biological E. to develop and commercialize recombinant H1N1 vaccine in India

VaxInnate Corporation today announced that it has granted Indian biopharmaceutical company Biological E. Limited a license to its recombinant H1N1 pandemic swine flu vaccine and is collaborating to facilitate the manufacture, clinical development and commercialization of the vaccine in India.

12 Jan 2010

HGS reports commercialization of late-stage products for systemic lupus and chronic hepatitis C

Human Genome Sciences, Inc. today will announce its priority goals for 2010 and report on the Company’s increasing momentum toward commercialization of late-stage products for systemic lupus and chronic hepatitis C in a presentation by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 28th Annual JPMorgan Healthcare Conference in San Francisco.

12 Jan 2010

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the U.S. and Europe, a drug that resolves tophi in less than one year would become the patient share leader in the chronic tophaceous gout patient subpopulation and would be used in the vast majority of patients who suffer severe tophaceous gout, according to surveyed U.S. and European rheumatologists.

12 Jan 2010

Pfizer/Medivation's AD drug Dimebon may garner peak year sales of $1.5 billion

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, if Pfizer/Medivation's Dimebon shows efficacy in two ongoing clinical trials in moderate to severe Alzheimer's disease that is equivalent to the impressive clinical trial data it has already shown to date in mild to moderate patients, these positive data would promote the use of Dimebon throughout the course of the disease.

12 Jan 2010

Amicus Therapeutics presents corporate outlook for 2010 at Annual J.P. Morgan Healthcare Conference

Amicus Therapeutics today outlined the Company's three key strategic priorities and presented a corporate outlook for 2010 at the 28th Annual J.P. Morgan Healthcare Conference.

12 Jan 2010

Mango effective against colon and breast cancer

Mango. If you know little about this fruit, understand this: It's been found to prevent or stop certain colon and breast cancer cells in the lab.

12 Jan 2010

Research shows diet plans can have a major influence on weight loss

Many people think the success of dieting, seemingly a national obsession following the excesses and resolutions of the holiday season, depends mostly on how hard one tries -- on willpower and dedication. While this does matter, new research has found that a much more subtle aspect of the diets themselves can also have a big influence on the pounds shed -- namely, the perceived complexity of a diet plan's rules and requirements.

12 Jan 2010

French maritime pine tree extract effective against hemorrhoids

According to the National Digestive Diseases Information Clearinghouse, about half of the U.S. population will have hemorrhoids by the age of 50. While the most common prescription to treat hemorrhoids is over-the-counter remedies, most patients do not report symptoms of acute hemorrhoidal attacks to their doctor until they are in severe distress, including bleeding.

12 Jan 2010

4SC commences treatment in its resminostat Phase II trial for HL

4SC AG, a drug discovery and development company focused on autoimmune and cancer indications, today announced the treatment of the first patient in a Phase II study evaluating resminostat (4SC-201), an oral pan-histone-deacetylase (HDAC) inhibitor in relapsed or refractory Hodgkin's Lymphoma (HL) patients.

12 Jan 2010

Sage Bionetworks, Pfizer sign new research partnership to analyze advanced network models of cancer

Sage Bionetworks has announced today a new research partnership with Pfizer, Inc. to build, analyze and exploit advanced network models of cancer. Pfizer will provide research funding to Sage to analyze large, globally coherent datasets from Pfizer, Sage and the public domain.

12 Jan 2010

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

MAP Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company's LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine. The Company announced in May 2009 that the efficacy portion of its Phase 3 FREEDOM-301 clinical study of LEVADEX met all four primary endpoints. The Company had previously anticipated initiating a second pivotal efficacy study in the first quarter of 2010.

12 Jan 2010

AvidBiotics and Ecolab to develop new technology that reduces food pathogens in meat products

AvidBiotics Corp. and Ecolab Inc. today announced an agreement under which they will work to develop a new technology to dramatically reduce the presence of the dangerous pathogen E. coli O157:H7 in red meat products.

12 Jan 2010

YM BioSciences announces results of cancer antibody-radionuclide conjugate development collaboration

YM BioSciences Inc. today announced results of a collaboration with researchers at the University of Toronto for the development of highly potent antibody-radionuclide conjugates for use in the treatment of cancer. The approach has successfully concluded its first series of proof-of-principle experiments establishing promise for future development and application.

12 Jan 2010

GSK exercises option to obtain exclusive license to develop and commercialize Traficet-EN

GlaxoSmithKline (GSK) and ChemoCentryx, Inc. today announced that GSK has exercised its option to obtain an exclusive license for further development and worldwide commercialization of Traficet-EN(TM) (CCX282-B), a specific CCR9 antagonist with the potential to offer a new approach for the treatment of inflammatory bowel diseases, including Crohn's disease.

12 Jan 2010

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Trubion Pharmaceuticals, Inc. today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).

12 Jan 2010

Biocomposites' geneX ds, the resorbable bone graft material with negative surface charge launched

Biocomposites, the pioneers in synthetic bone graft materials have launched geneX ds, a dual syringe mixing and minimally invasive delivery system containing geneX, the unique resorbable bone graft material with a negative surface charge.

12 Jan 2010

Efficacy News and Research

NOVAVAX completes pre-clinical safety and efficacy study of its RSV vaccine candidate

Patient enrollment in Spherix's global Phase 3 clinical trial NEET completed

Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

Preliminary results from Nektar Therapeutics' NKTR-102 Phase 2 study in platinum-resistant ovarian cancer

VaxInnate grants license to Biological E. to develop and commercialize recombinant H1N1 vaccine in India

HGS reports commercialization of late-stage products for systemic lupus and chronic hepatitis C

Market for chronic tophaceous gout medications will be led by drug that resolves tophi in less than a year

Pfizer/Medivation's AD drug Dimebon may garner peak year sales of $1.5 billion

Amicus Therapeutics presents corporate outlook for 2010 at Annual J.P. Morgan Healthcare Conference

Mango effective against colon and breast cancer

Research shows diet plans can have a major influence on weight loss

French maritime pine tree extract effective against hemorrhoids

4SC commences treatment in its resminostat Phase II trial for HL

Sage Bionetworks, Pfizer sign new research partnership to analyze advanced network models of cancer

Second pivotal efficacy study not required for MAP Pharmaceuticals' LEVADEX NDA

AvidBiotics and Ecolab to develop new technology that reduces food pathogens in meat products

YM BioSciences announces results of cancer antibody-radionuclide conjugate development collaboration

GSK exercises option to obtain exclusive license to develop and commercialize Traficet-EN

Pfizer commences SBI-087 Phase 2 clinical trial for RA

Biocomposites' geneX ds, the resorbable bone graft material with negative surface charge launched

Leveraging the power of automation to boost research

Automating research - solutions and best practices

How can microdialysis benefit drug development

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