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Phase Forward to participate in DIA Workshop and Clinical Trial Supply event

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, will participate in two industry events this month: The 13th Annual DIA Workshop in Japan for Clinical Data Management (Booths 4 and 5) and VIB Pharma’s 11th Annual Clinical Trial Supply (Booth 3).

4 Feb 2010

Results from three phase two studies show the effectiveness of Tanezumab

Tanezumab, a humanized monoclonal antibody that targets nerve-growth factor, reduced pain in three common pain conditions, according to the results from three phase two studies presented today in a single poster at the American Academy of Pain Medicine's 26th Annual Meeting.

4 Feb 2010

Transplantation of pulmonary progenitor cells derived from hESCs promising for acute lung injury

Stem cell researchers exploring a new approach for the care of respiratory diseases report that an experimental treatment involving transplantable lung cells was associated with improved outcomes in tests on mice with acute lung injury. The lung cells were derived from human embryonic stem cells (hESCs). Findings by investigators at The University of Texas Health Science Center at Houston are scheduled to appear in the March issue of Molecular Therapy.

4 Feb 2010

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

Seattle Genetics, Inc. and Millennium Pharmaceuticals, Inc.: The Takeda Oncology Company today announced that they have initiated a phase I clinical trial of brentuximab vedotin (SGN-35) in combination with chemotherapy for the treatment of newly diagnosed Hodgkin lymphoma patients. Brentuximab vedotin is an antibody-drug conjugate (ADC) that is also in single-agent clinical trials, including a pivotal trial for relapsed and refractory Hodgkin lymphoma and a phase II trial for systemic anaplastic large cell lymphoma.

4 Feb 2010

UBC announces the opening of new global office in Tokyo, Japan

nited BioSource Corporation (UBC) today announced the opening of its newest global office in Tokyo, Japan. The UBC office will be led by Kumpei Kobayashi, PharmD, a biopharmaceutical industry veteran with over 20 years of product development experience throughout the Asia-Pacific region.

4 Feb 2010

Phase 2a clinical trial results of VX-809 in patients with CF announced

Vertex Pharmaceuticals Incorporated today announced results from a preliminary analysis of data from a 28-day Phase 2a clinical trial of VX-809 in patients with cystic fibrosis (CF) who are homozygous for the F508del mutation.

4 Feb 2010

TGen, Horizon Discovery partner in development of novel cancer cell-lines

The Translational Genomics Research Institute (TGen) and Horizon Discovery today announced plans to develop human disease models for use in TGen's cancer research.

3 Feb 2010

Hypertension drug market to decrease through 2013 due to generic erosion and few emerging therapies

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in addition to extensive generic erosion, the hypertension drug market will be constrained through 2018 by a pipeline containing very few emerging therapies with novel mechanisms of action. Gilead's darusentan was positioned to be the next emerging therapy with a novel mechanism of action to reach the hypertension market. However, following darusentan's failure to meet its primary endpoint in the recent DORADO-AC Phase III clinical trial, further development of the agent has been terminated.

3 Feb 2010

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

Hovione is announcing the filing of a new drug application in Japan by its licensee Daiichi Sankyo Company Ltd. for the influenza drug CS-8958, which is delivered using Hovione's TwinCaps(R) inhaler.

2 Feb 2010

New formulated soy product offers heart health benefits

Just in time for Heart Health Month, EcoNugenics introduces the newest in their scientifically formulated product line: CIRCUTOL™ Cardiovascular Health Support.

2 Feb 2010

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Spectrum Pharmaceuticals signs co-development and commercialization agreement with TopoTarget A/S

Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has entered into a co-development and commercialization agreement with TopoTarget A/S for Belinostat, a novel histone deacetylase (HDAC) inhibitor.

2 Feb 2010

Decision Resources: Benlysta to garner more than $500M in 2018

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, following its expected regulatory approval in 2011 in the United States and Europe, Human Genome Sciences/GlaxoSmithKline's Benlysta will garner sales of more than $500 million in 2018 in the systemic lupus erythematosus drug market.

2 Feb 2010

Positive results from Phosphagenics' TPM Phase 1B clinical study for transdermal delivery of oxycodone

Phosphagenics Limited today announced positive results from a Phase 1B clinical study using the Company’s patented TPM™ (Targeted Penetration Matrix) for the transdermal delivery of oxycodone. The results of the successful trial demonstrate that daily application of a TPM™ patch delivers therapeutic levels of oxycodone into the blood stream in a reproducible, consistent and sustained manner.

2 Feb 2010

Long-chain omega-3 polyunsaturated fatty acids may reduce risk of psychotic disorders

Individuals at extremely high risk of developing psychosis appear less likely to develop psychotic disorders following a 12-week course of fish oil capsules containing long-chain omega-3 polyunsaturated fatty acids, according to a report in the February issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

2 Feb 2010

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Pervasis Therapeutics, Inc. today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial for Vascugel®, an investigational new drug for the prevention of hemodialysis access graft failure.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

Congress faces one-month deadline on doctor payment fix

The doctor payment fix and several marketplace issues, such as insurance red tape and malpractice cases, continue to loom while health care reform efforts stall.

1 Feb 2010

FDA approves Allergan's JUVÉDERM XC dermal filler

Allergan, Inc. today announced the U.S. Food and Drug Administration’s (FDA) approval of JUVÉDERM® XC, a new formulation of the currently FDA-approved JUVÉDERM® dermal filler and the latest advancement in hyaluronic acid (HA) dermal fillers.

1 Feb 2010

Managing Myeloma reviews past accomplishments; discusses future goals in evolving therapeutic landscape

Managing Myeloma (www.ManagingMyeloma.com) convened the 2010 Multidisciplinary Advisory Board on January 16, 2010 to review the past 18 months and discuss the educational and practical needs of myeloma practitioners in an evolving therapeutic landscape.

1 Feb 2010

Clinical Trial News and Research

Phase Forward to participate in DIA Workshop and Clinical Trial Supply event

Results from three phase two studies show the effectiveness of Tanezumab

Transplantation of pulmonary progenitor cells derived from hESCs promising for acute lung injury

Brentuximab vedotin-chemotherapy combination clinical trial for Hodgkin lymphoma announced

UBC announces the opening of new global office in Tokyo, Japan

Phase 2a clinical trial results of VX-809 in patients with CF announced

TGen, Horizon Discovery partner in development of novel cancer cell-lines

Hypertension drug market to decrease through 2013 due to generic erosion and few emerging therapies

Hovione announces filing of new drug application in Japan for the influenza drug CS-8958

New formulated soy product offers heart health benefits

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

Spectrum Pharmaceuticals signs co-development and commercialization agreement with TopoTarget A/S

Decision Resources: Benlysta to garner more than $500M in 2018

Positive results from Phosphagenics' TPM Phase 1B clinical study for transdermal delivery of oxycodone

Long-chain omega-3 polyunsaturated fatty acids may reduce risk of psychotic disorders

Pervasis Therapeutics reaches agreement with FDA on pivotal Phase 3 clinical trial for Vascugel

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Congress faces one-month deadline on doctor payment fix

FDA approves Allergan's JUVÉDERM XC dermal filler

Managing Myeloma reviews past accomplishments; discusses future goals in evolving therapeutic landscape

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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