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FDA grants accelerated approval for Allos Therapeutics’ FOLOTYN

Allos Therapeutics, Inc. (Nasdaq:ALTH) today announced that last night the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

28 Sep 2009

Quintiles opens an expanded regional facility

To enhance service offerings throughout Europe, Quintiles Transnational Corp. today announced the opening of an expanded regional facility near Edinburgh, Scotland. The purpose-built facility consolidates three buildings into a single state-of-the-art complex.

28 Sep 2009

Investigational vaccine regimen 31% effective in preventing HIV infection

In an encouraging development, an investigational vaccine regimen has been shown to be well-tolerated and to have a modest effect in preventing HIV infection in a clinical trial involving more than 16,000 adult participants in Thailand. Following a final analysis of the trial data, the Surgeon General of the U.S. Army, the trial sponsor, announced today that the prime-boost investigational vaccine regimen was safe and 31 percent effective in preventing HIV infection.

27 Sep 2009

Pfizer to commence Phase 3 trial of oral c-Met and ALK inhibitor

Pfizer Oncology announced today that it will initiate a global, Phase 3 clinical trial of its investigational oral c-Met and ALK inhibitor, PF-02341066, versus standard of care chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) carrying the ALK (anaplastic lymphoma kinases) fusion gene, who have progressed on one prior treatment with a platinum-based chemotherapy.

26 Sep 2009

HORIZONS-AMI clinical trial demonstrates efficacy of drug-eluting stent

Late-breaking data from the landmark HORIZONS-AMI clinical trial, presented at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, demonstrated that after two years, in heart attack patients, the use of a drug-eluting stent (paclitaxel) was safer and more effective than a bare-metal stent; and that the administration of the anticoagulant medication bivalirudin enhanced safety and efficacy compared to the use of heparin + GPIIb/IIIa inhibitors.

25 Sep 2009

Affymax may sell up to.$60 million of its registered common stock to Azimuth Opportunity

Affymax, Inc. (Nasdaq:AFFY) today announced that it has obtained an issuer managed equity facility under which it may sell up to $60 million of its registered common stock to Azimuth Opportunity, Ltd. Affymax is not obligated to utilize any of the facility, which has a term of 24 months.

25 Sep 2009

NCI awards Altor Bioscience a $3 MM grant to develop its targeted cancer therapeutic ALT-801

Altor BioScience Corporation announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase II Bridge Grant by the National Cancer Institute (NCI). The award of $3 MM over three years will help Altor further its clinical development of ALT-801, a novel tumor-targeted immunotherapeutic designed to improve the efficacy and safety of the FDA-approved anticancer cytokine, interleukin-2 (IL-2).

25 Sep 2009

Investigational New Drug application for Uricase-PEG 20 approved

EnzymeRx, LLC, a clinical-stage biotechnology company, announced that its Investigational New Drug (IND) application for Uricase-PEG 20, filed with the U.S. Food and Drug Administration (FDA) last month, has become effective.

25 Sep 2009

ethica Clinical Research, Matrix Pharma sign worldwide agreement

ethica Clinical Research Inc. ("ethica"), a Contract Research Organization (CRO) headquartered in Montreal, and Matrix Pharma Canada Inc. ("Matrix Pharma"), have announced the signing of an agreement, valued at CAD1.25 Million, that provides ethica with an exclusive, worldwide license to promote and use Matrix Pharma's proprietary research data analysis technology for life sciences applications, notably for the identification and optimization of biomarkers.

25 Sep 2009

Vertex Pharmaceuticals to present SVR data at the 60th Annual Meeting of the American Association

Vertex Pharmaceuticals Incorporated today announced that sustained virologic response (SVR) data from Study C208, which evaluated twice-daily dosing of Vertex’s investigational hepatitis C virus (HCV) protease inhibitor telaprevir, will be presented in an oral presidential plenary session at the 60th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) taking place Oct. 30 – Nov. 3, 2009 in Boston.

25 Sep 2009

Researchers to use Intravenous Immune Globulin for slowing AD progression

Researchers from the Memory and Cognition Center at University Hospitals Case Medical Center will begin testing an intriguing new approach to slowing down the progression of Alzheimer's Disease (AD) using Intravenous Immune Globulin (IGIV), also known as gammaglobulin.

25 Sep 2009

PACTR: The first WHO endorsed trials registry in Africa

The Pan-African Clinical Trials Registry (PACTR) has been accepted as a primary clinical trials registry - the first World Health Organization (WHO) endorsed trials registry in Africa. This registry will feed data into the global WHO International Clinical Trials Registry Platform (ICTRP) search portal facilitating African representation in the global picture of planned, ongoing and completed clinical trials. The Registry is currently funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and coordinated by the South African Cochrane Centre (SACC) at the Medical Research Council (MRC).

25 Sep 2009

Results from COGENT clinical trial presented at TCT symposium

Results from a late breaking clinical trial called COGENT demonstrate that the combination of giving patients clopidogrel, a blood thinner commonly prescribed to patients with cardiovascular disease, and stomach medicines such as omeprazole, known as proton pump inhibitors (PPIs), did not lead to adverse events, as some prior studies had suggested.

25 Sep 2009

PROSPECT clinical trial results announced

Abbott today announced primary results from its groundbreaking PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) clinical trial.

25 Sep 2009

Huachansu may slow cancer progression

Huachansu, a Chinese medicine that comes from the dried venom secreted by the skin glands of toads, has tolerable toxicity levels, even at doses eight times those normally administered, and may slow disease progression in some cancer patients, say researchers from The University of Texas M. D. Anderson Cancer Center.

25 Sep 2009

Phase III clinical trial of investigational HIV vaccine regimen complete

Global Solutions for Infectious Diseases (“GSID”) announced today that a Phase III clinical trial of an investigational HIV vaccine regimen has been shown to be safe and modestly effective in preventing HIV infection. The double-blind, placebo controlled study was conducted in Thailand among more than 16,000 volunteers.

25 Sep 2009

Webcast on the treatment of cardiovascular diseases

On September 24th at 7:00pm EDT, Dr. Holly Andersen, Director of Education and Outreach at the Ronald O. Perelman Heart Institute at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, will host a live webcast exploring the advances and innovations in the treatment of cardiovascular disease. The air live on ORLive.com from the Hospital's new Ronald O. Perelman Heart Institute.

25 Sep 2009

Partial success reported in the Phase 3 trial of HIV/AIDS vaccine

GeoVax Labs, Inc., an Atlanta-based, biopharmaceutical company developing human vaccines for HIV/AIDS (HIV-1, Human Immunodeficiency Virus), was pleased to hear the announcement today of partial success in the recently completed Phase 3 trial in Thailand of a candidate HIV/AIDS vaccine owned by Sanofi-Aventis and Global Solutions for Infectious Diseases.

25 Sep 2009

Investigational vaccine shows modest potential for protecting against HIV infection

For the first time, scientists say an investigational vaccine has modest potential for protecting people against HIV infection, the Associated Press reports. "The vaccine — a combination of two previously unsuccessful vaccines — cut the risk of becoming infected with HIV by ... 31 percent in the world's largest [HIV] vaccine trial of more than 16,000 volunteers in Thailand, researchers announced Thursday in Bangkok," the news service writes (Marchione/Casey, 9/24).

25 Sep 2009

Multi-modality imaging to identify plaque

Late-breaking results from the PROSPECT clinical trial shed new light on the types of vulnerable plaque that are most likely to cause sudden, unexpected adverse cardiac events, and on the ability to identify them through imaging techniques before they occur.

25 Sep 2009