Clinical Trial News and Research

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Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

Depomed, Inc. today announced top-line results from a Phase 3 clinical trial demonstrating DM-1796 (also referred to as gabapentin ER) achieved a statistically significant reduction in pain associated with postherpetic neuralgia (PHN) versus placebo using the baseline observation carried forward (BOCF) method required by FDA.

5 Oct 2009

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

GlaxoSmithKline and XenoPort, Inc. today announced top-line results from a Phase II clinical trial evaluating GSK1838262/XP13512 (gabapentin enacarbil) in adult patients with neuropathic pain associated with post-herpetic neuralgia (PHN) who have had a history of inadequate response to gabapentin doses of 1800 mg/day or higher.

5 Oct 2009

GVK Biosciences and Quantitative Solutions to develop and market clinical trial outcome databases

GVK Biosciences (GVK BIO), Asia’s leading integrated research services provider and Quantitative Solutions (QS), a modeling and simulation (M&S) consultancy to the pharmaceutical and biotech industry, announced a strategic partnership to develop and market clinical trial outcome databases.

5 Oct 2009

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

Inovio Biomedical Corporation, a leader in DNA vaccine design, development and delivery, announced today interim safety and immunogenicity data from its therapeutic cervical cancer vaccine (VGX-3100) trial. VGX-3100 is a DNA vaccine targeting the E6 and E7 proteins of human papillomavirus (HPV) types 16 and 18 and is delivered via in vivo electroporation.

5 Oct 2009

The Lewin Group issues recommendations to overcome barriers obstructing the lupus drug development

Today, The Lewin Group, a national health care consulting firm, issued recommendations on ways to overcome the barriers that have obstructed lupus drug development resulting in no new drug approval for this disease in more than 50 years - since the Eisenhower Administration.

From CSL Ltd 5 Oct 2009

Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

Xcellerex, Inc. and Itero Biopharmaceuticals, Inc. announced today that they have signed a Letter of Intent to enter into a strategic collaboration for the production of Itero’s lead product, an undisclosed commercially differentiated therapeutic protein. Itero will initiate technology transfer for the product to Xcellerex immediately.

3 Oct 2009

HCRI commences patient enrollment in dual antiplatelet therapy study

The Harvard Clinical Research Institute (HCRI) announced today that the first patients have been enrolled in the DAPT Study, marking the official initiation of the four-year clinical trial to investigate the duration of dual antiplatelet therapy (DAPT, the combination of aspirin and a thienopyridine/antiplatelet medication to reduce the risk of blood clots) following drug-eluting stent implantations.

3 Oct 2009

TMS Health expands its Boca Raton Headquarters

TMS Health, the largest provider of outbound and inbound Teleservices to the U.S. Pharmaceutical Industry, is expanding its Boca Raton headquarters.

3 Oct 2009

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

Cardium Therapeutics announced plans to report on preliminary safety and efficacy data from its Matrix Phase 2b Excellarate clinical study. Based on guidance from Cardium's independent clinical data management company which is currently completing the statistical analysis of all data for the Matrix clinical trial, Cardium expects to receive the locked unblinded data set and be in position to announce preliminary results on or before October 14, 2009.

3 Oct 2009

Quest PharmaTech acquires immunotherapeutic antibody products from Paladin Labs

Quest PharmaTech Inc. ("Quest" or the "Company"), a pharmaceutical company developing and commercializing products for the treatment of cancer, today announced that it has acquired a pipeline of late-stage immunotherapy product candidates from Paladin Labs Inc. ("Paladin").

3 Oct 2009

Chinese government places second purchase order for Sinovac Biotech's H1N1 vaccine

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that Sinovac has received its second purchase order for its H1N1 vaccine, PANFLU.1, from the Ministry of Industry and Information Technology of the People's Republic of China for the national stockpiling plan.

3 Oct 2009

Clinical study data of Thymosin beta 4 presented

REGENERX BIOPHARMACEUTICALS, INC. today reported on several clinical studies with Thymosin beta 4 (Tβ4) presented the Second International Symposium on Thymosins in Health and Disease, in Catania, Italy.

3 Oct 2009

FDA approves Bayer's IUD Mirena for treating heavy menstrual bleeding

The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

3 Oct 2009

Phase 1b clinical trial results of PEG-Interferon lambda to be presented

Bristol-Myers Squibb Company and ZymoGenetics, Inc. (NASDAQ:ZGEN) announced that final results from a Phase 1b clinical trial in patients with hepatitis C (HCV) treated with PEG-Interferon lambda, a new class of interferon, in combination with ribavirin will be presented at the American Association for the Study of Liver Diseases (AASLD) annual meeting October 30–November 3, 2009, in Boston.

3 Oct 2009

EMEA grants positive opinion for Baxter's CELVAPAN H1N1 pandemic vaccine

Baxter International Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its “positive opinion” for CELVAPAN H1N1 pandemic vaccine using Baxter’s Vero cell technology. This positive opinion confirms the acceptability of Baxter’s regulatory submission to obtain final marketing authorization and licensure of the product.

From Baxter International Inc. 3 Oct 2009

NIH awards Titan $7.6M grant for Probuphine clinical development

Titan Pharmaceuticals, Inc today announced that the National Institutes of Health (NIH) has awarded a Research and Research Infrastructure Grand Opportunities grant to the company through the American Reinvestment and Recovery Act of 2009 (ARRA). The two year grant for Probuphine clinical development is expected to provide approximately $7.6 million, with the first year award of approximately $ 5.6 million now made available to Titan by the NIH.

3 Oct 2009

Aspirin use in seniors study

Researchers at Monash University and the United States-based Berman Center for Outcomes & Clinical Research will lead an international clinical trial to test whether taking aspirin contributes to good health in the elderly.

1 Oct 2009

Catalyst Pharmaceutical Partners to continue development of CPP-109 drug

Catalyst Pharmaceutical Partners, Inc. today announced that the Company will continue to develop CPP-109 (Catalyst's version of vigabatrin) for the treatment of cocaine and methamphetamine addiction.

1 Oct 2009

First prescription foam formulation of benzoyl peroxide available

Onset Therapeutics, a specialty pharmaceutical company focused on dermatology, announced today the commercial availability of BenzEFoam (benzoyl peroxide) 5.3% Emollient Foam, the first prescription foam formulation of benzoyl peroxide.

1 Oct 2009

CVRx commences enrollment in study evaluating the Rheos System to treat heart failure

CVRx, Inc. reported the first enrollment of a patient in the HOPE4HF Trial, a study that is evaluating the Rheos System to treat heart failure. The Rheos System uses Baroreflex Activation Therapy® technology, an entirely new non-pharmaceutical approach designed to treat cardiovascular disease. The HOPE4HF Trial is being conducted under an approved investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA).

1 Oct 2009

Clinical Trial News and Research

Positive results from Depomed's Phase 3 clinical trial of DM-1796 for postherpetic neuralgia

GSK reports positive Phase II results from trial evaluating GSK1838262 for post-herpetic neuralgia

GVK Biosciences and Quantitative Solutions to develop and market clinical trial outcome databases

Phase I clinical trial results to test the safety and immunogenicity of VGX-3100 released

The Lewin Group issues recommendations to overcome barriers obstructing the lupus drug development

Xcellerex and Itero collaborate in production of an undisclosed therapeutic protein

HCRI commences patient enrollment in dual antiplatelet therapy study

TMS Health expands its Boca Raton Headquarters

Cardium announces positive results from the Phase 1 / 2 clinical study of Excellarate

Quest PharmaTech acquires immunotherapeutic antibody products from Paladin Labs

Chinese government places second purchase order for Sinovac Biotech's H1N1 vaccine

Clinical study data of Thymosin beta 4 presented

FDA approves Bayer's IUD Mirena for treating heavy menstrual bleeding

Phase 1b clinical trial results of PEG-Interferon lambda to be presented

EMEA grants positive opinion for Baxter's CELVAPAN H1N1 pandemic vaccine

NIH awards Titan $7.6M grant for Probuphine clinical development

Aspirin use in seniors study

Catalyst Pharmaceutical Partners to continue development of CPP-109 drug

First prescription foam formulation of benzoyl peroxide available

CVRx commences enrollment in study evaluating the Rheos System to treat heart failure

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