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Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Celldex Therapeutics, Inc. today announced that the Company presented initial clinical data on CDX-1401 at the 25th Annual Meeting of the International Society of Biological Therapy of Cancer (iSBTc) in Washington, DC. CDX-1401 is a novel antibody-based targeted cancer vaccine candidate being evaluated as a treatment for patients with melanoma and other cancers that are known to express the tumor antigen NY-ESO-1.

5 Oct 2010

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Onconova Therapeutics, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon- (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

5 Oct 2010

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Enzo Biochem, Inc., announced today that, following filing of a investigational new drug (IND) application with the FDA, its Enzo Therapeutics division is commencing a clinical trial of Optiquel™ , the Company's proprietary oral therapeutic for chronic non-infectious uveitis. The trial is designed as a randomized, double-masked, placebo-controlled study with a long-term follow-up and is being conducted by the National Institute of Health's National Eye Institute (NEI).

4 Oct 2010

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Onconova Therapeutics®, Inc. announced agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase 3 trial for Estybon™ (ON 01910.Na) as monotherapy in patients with myelodysplastic syndromes (MDS), diseases affecting the production of healthy blood cells in the bone marrow.

4 Oct 2010

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Merck today announced that final results from two pivotal Phase III studies of boceprevir, its investigational oral hepatitis C protease inhibitor, will be presented in oral plenary sessions at the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which is taking place from Oct. 29 through Nov. 2 in Boston. Results for boceprevir in response-guided therapy strategies, which evaluated treatment durations shorter than current standard therapy, will be presented during the meeting.

4 Oct 2010

Neupro improves quality of life in Parkinson's disease patients

People with Parkinson's disease who used once-daily Neupro® (rotigotine) in the RECOVER trial achieved improvements in quality of life, in addition to previously reported beneficial effects on motor and non-motor symptoms.

4 Oct 2010

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that previously reported results from its Phase 2 study evaluating tivozanib for the treatment of advanced renal cell carcinoma (RCC) will be presented at the Ninth International Kidney Cancer Symposium (IKCS) in Chicago, Illinois, October 1-2, 2010.

4 Oct 2010

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Sanofi-aventis announced today that data from the Phase III TROPIC study, which was the basis for the June 2010 U.S. Food and Drug Administration (FDA) approval of Jevtana (cabazitaxel) Injection, was published in the October 2, 2010 print edition of The Lancet in an article titled "Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial.

4 Oct 2010

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Array BioPharma Inc. today announced positive interim results of its novel, oral HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in patients with advanced cancer.

4 Oct 2010

Celsion presents Phase I/II DIGNITY trial data at 2010 Breast Cancer Symposium

Celsion Corporation announced today that interim data from its Phase I/II DIGNITY trial of ThermoDox in Recurrent Chest Wall (RCW) Breast Cancer were presented at the poster session at the 2010 Breast Cancer Symposium.

3 Oct 2010

Bristol-Myers Squibb to present multiple compounds’ data at AASLD annual meeting

New data on multiple Bristol-Myers Squibb Company compounds will be presented at the 61st annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston from October 29 to November 2.

3 Oct 2010

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Isotechnika Pharma Inc. announces that the results of the CONFIRM1 clinical trial conducted by its medical device partner, Atrium Medical Corporation, were presented by Glenn Van Langenhove, MD, PhD (Middelheim Hospital in Antwerp, Belgium), the principal investigator, at the Transcatheter Cardiovascular Therapeutics (TCT) 2010 Scientific Symposium in Washington, DC last week.

3 Oct 2010

Argos' AGS-003 in combination with sunitinib demonstrates favorable PFS for renal cell carcinoma

Argos Therapeutics announced that its Arcelis immunotherapy for renal cell carcinoma (RCC), AGS-003, demonstrated favorable progression-free survival (PFS) and safety in combination with sunitinib, based upon updated results from an ongoing Phase 2 trial.

1 Oct 2010

LSUHSC-S receives $3.9M NIDA grant to develop EMB-001 drug for cocaine dependence

Embera NeuroTherapeutics, Inc., a specialty pharmaceutical company developing novel treatments for addiction and obesity, announced today that the Louisiana State University Health Sciences Center (LSUHSC-S) has received a $3.9 million dollar grant from the National Institute on Drug Abuse (NIDA). The grant will support the next stages of development for Embera's drug candidate EMB-001 to treat cocaine dependence, as well as advance EMB-001 into clinical testing.

1 Oct 2010

AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

AcelRx Pharmaceuticals, Inc. today announced that it has completed an End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) for ARX-02, a proprietary Sufentanil NanoTab™ Breakthrough Pain Management System for the treatment of cancer breakthrough pain in opioid-tolerant patients. FDA reviewed a package based on the previously announced positive Phase 2 clinical study results to date for ARX-02 and provided AcelRx with guidance on the Phase 3 program design and NDA requirements.

1 Oct 2010

Benicar better than Cozaar in reducing blood pressure: Study

New study results show that patients treated with Benicar® (olmesartan medoxomil) 40 mg once daily had significantly greater reductions in blood pressure and higher rates of goal attainment than patients receiving Cozaar® (losartan potassium) 100 mg once daily at week 8, according to findings of a new head-to-head study presented today at the late breaker session at the 23rd Scientific Meeting of the International Society of Hypertension (ISH) in Vancouver, Canada.

1 Oct 2010

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

Intra-Cellular Therapies, Inc. today announced results from studies demonstrating the anti-Parkinson and other beneficial effects of ITI-002 (IC200214), the Company's novel and selective phosphodiesterase type I (PDE1) inhibitor.

1 Oct 2010

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Emergent BioSolutions Inc. announced today that its anthrax monoclonal antibody development program investigating AVP-21D9 for the treatment of inhalational anthrax has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). Emergent recently commenced a Phase I clinical trial for AVP-21D9, which is a fully human monoclonal antibody product candidate being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease.

1 Oct 2010

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Featured in the October edition of the Journal of Thoracic Oncology (JTO), data from The Tarceva Lung Cancer Survival Treatment (TRUST) confirms the safety and efficacy profile of erlotinib, a highly potent oral active, reversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine-kinase (TK) activity in a large heterogeneous non-small cell lung cancer (NSCLC) population.

1 Oct 2010

Herpevac Trial for Women finds experimental vaccine ineffective in prevention of genital herpes disease

An experimental vaccine intended to prevent genital herpes disease in women, although generally safe and well-tolerated, proved ineffective when tested in the recently concluded clinical study known as the Herpevac Trial for Women.

1 Oct 2010

Drug Trial News

Celldex Therapeutics presents initial clinical data on CDX-1401 cancer vaccine candidate at iSBTc meeting

Onconova announces agreement with FDA for Estybon- MDS Phase 3 trial

Enzo commences clinical trial of Optiquel for chronic non-infectious uveitis

Onconova enters agreement with FDA for Estybon Phase 3 trial SPA

Merck's boceprevir Phase III studies for HCV to be presented at 61st AASLD

Neupro improves quality of life in Parkinson's disease patients

AVEO Pharmaceuticals to present tivozanib Phase 2 study results at IKCS Symposium

Sanofi-aventis publishes Phase III TROPIC study data in The Lancet article

Array BioPharma to present positive interim results of Phase 1 ARRY-380 trial at ASCO Symposium

Celsion presents Phase I/II DIGNITY trial data at 2010 Breast Cancer Symposium

Bristol-Myers Squibb to present multiple compounds’ data at AASLD annual meeting

Isotechnika announces CONFIRM1 clinical trial results at TCT 2010 Symposium

Argos' AGS-003 in combination with sunitinib demonstrates favorable PFS for renal cell carcinoma

LSUHSC-S receives $3.9M NIDA grant to develop EMB-001 drug for cocaine dependence

AcelRx completes ARX-02 End-of-Phase 2 meeting with FDA for cancer breakthrough pain management system

Benicar better than Cozaar in reducing blood pressure: Study

Intra-Cellular Therapies demonstrates ability of ITI-002 to improve motor and non-motor behaviors in PD

FDA grants Emergent Fast Track Designation for AVP-21D9 anthrax monoclonal antibody development program

Global phase IV study confirms efficacy of erlotinib in treatment of non-small cell lung cancer

Herpevac Trial for Women finds experimental vaccine ineffective in prevention of genital herpes disease

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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