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Genzyme reports results of Clolar combination Phase 3 trial in adult AML

Genzyme Corporation announced results today from its CLASSIC I phase 3 trial comparing Clolar® (clofarabine) in combination with the chemotherapy agent cytarabine (ara-c) to cytarabine plus placebo in relapsed-refractory adult acute myeloid leukemia (AML).

21 Oct 2010

IRB approves CEL-SCI’s Multikine Phase III clinical trial for head and neck cancer

CEL-SCI Corporation announced today it has received approval from seven hospital Institutional Review Boards in India to begin enrollment of subjects for a Phase III clinical trial of Multikine, the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer.

21 Oct 2010

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

Arena Pharmaceuticals, Inc. announced today results from a Phase 1 clinical trial of APD916, a novel drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy with cataplexy.

20 Oct 2010

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

Ipsen announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia. Expected to enter pivotal clinical trials before the end of this year, OBI-1 is designed to treat individuals with hemophilia who have developed inhibitory antibodies (inhibitors) against human Factor VIII (hFVIII).

20 Oct 2010

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Los Alamos National Laboratory researcher Bette Korber is part of an international team of investigators working to design and implement the first human trial of a mosaic HIV vaccine candidate. The vaccine represents a novel strategy for fighting the virus that causes AIDS by attempting to address one of the most daunting challenges in HIV vaccine design: the virus's extensive genetic diversity.

20 Oct 2010

Retina Implant's first clinical trial results presented at 2010 AAO annual meeting

Retina Implant AG, a leading developer of subretinal implants for the visually impaired, is proud to announce Co-Founder and Chairman Eberhart Zrenner, M.D. was invited to present the exciting results of clinical trials he has been leading since 2005 by the American Academy of Ophthalmology at this year's annual meeting that took place October 16-19 at McCormick Place in Chicago, Ill.

20 Oct 2010

Highlights of world's largest ophthalmic education conference

Results of clinical research on new presbyopia treatments now available in Europe-and possibly available soon in the United States-were reported in today's Scientific Program of the 2010 Joint Meeting of the American Academy of Ophthalmology (AAO) and Middle East-Africa Council of Ophthalmology (MEACO). The AAO-MEACO meeting is the world's largest, most comprehensive ophthalmic education conference and is in session October 16 through 19 at McCormick Place, Chicago.

20 Oct 2010

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

Neuralstem, Inc. updated the progress of its ongoing Phase I human clinical trial of the company's spinal cord stem cells in the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig's disease) at Emory University in Atlanta, Georgia.

20 Oct 2010

UTHSC-Houston initiates enrollment in NanoLogix technology trial for detection of GBS in pregnant women

NanoLogix, an innovator in the accelerated detection and identification of microorganisms, announced today that the University of Texas Health Science Center in Houston is enrolling 300 patients in an ongoing clinical trial to study the speed and accuracy of NanoLogix technology. The trial is designed to compare NanoLogix technology to current methods in use for detection and identification of Group B Streptococcus (GBS) in pregnant women.

20 Oct 2010

UH researchers to explore role of Vitamin D in esophageal cancer prevention

In a first-of-its-kind clinical trial, physicians at University Hospitals (UH) Case Medical Center who are Case Western Reserve University School of Medicine researchers are exploring the role of Vitamin D in preventing esophageal cancer.

20 Oct 2010

Particle Sciences enters licensing, technology agreement with Solubest

Particle Sciences Inc. (PSI), a leading pharmaceutical CRO and SoluBest have entered into a licensing and technology development agreement. Under the agreement, Particle Sciences will be the exclusive contract research provider in the U.S. for SoluBest's Solumer technology.

20 Oct 2010

Japanese study finds proton beam therapy safe and effective for Stage I inoperable NSCLC

Proton beam therapy is safe and effective and may be superior to other conventional treatments for Stage I inoperable non-small cell lung cancer (NSCLC) patients, according to a study in the October issue of the International Journal of Radiation Oncology•Biology•Physics, the official journal of the American Society for Radiation Oncology (ASTRO).

20 Oct 2010

Adamis acquires prostrate drug candidates from Colby Pharmaceuticals

Adamis Pharmaceuticals Corporation today announced the completion of the acquisition from Colby Pharmaceuticals of the remaining exclusive license agreements relating to two drug product candidates for the treatment of prostate cancer (PCa).

20 Oct 2010

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

MannKind Corporation today announced the first patient has been dosed in a phase 2 clinical trial of the novel, investigational cancer vaccine MKC1106-MT. As a part of MannKind's cancer immunotherapy program, this phase 2 study will evaluate the safety, tolerability, immune response and clinical response of MKC1106-MT in patients with advanced melanoma.

20 Oct 2010

Research paves way to understand the mechanism of leptin therapy to improve type 1 diabetes

New findings by UT Southwestern Medical Center researchers suggest a novel role for the brain in mediating beneficial actions of the hormone leptin in type 1 diabetes.

20 Oct 2010

European Commission grants orphan drug status to OBI-1 for hemophilia treatment

Inspiration Biopharmaceuticals, Inc. announced today that the European Commission has granted orphan drug status for OBI-1 for the treatment of hemophilia.

20 Oct 2010

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Ceregene, Inc., a biopharmaceutical company, announced today that enrollment has begun in a new double-blind sham surgery-controlled Phase 2b study evaluating CERE-120 in Parkinson's disease patients. CERE-120 is a gene therapy product that delivers the neurotrophic factor neurturin to degenerating or dying dopamine neurons. Data from the first Phase 2 clinical trial of CERE-120 are being published later this year in Lancet Neurology (to appear online October 21, 2010).

20 Oct 2010

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

The U.S. Food and Drug Administration today approved Pradaxa capsules (dabigatran etexilate) for the prevention of stroke and blood clots in patients with abnormal heart rhythm (atrial fibrillation).

20 Oct 2010

BioMarin announces BMN-111 program for treatment of achondroplasia

BioMarin Pharmaceutical Inc. today announced its program for BMN-111, a peptide therapeutic for the treatment of achondroplasia. BioMarin plans to file an IND in the fourth quarter of 2011 and to initiate a Phase 1 clinical trial by the first quarter of 2012.

19 Oct 2010

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

Forest Laboratories, Inc., an international pharmaceutical manufacturer and marketer, announced that diluted earnings per share equaled $1.00 in the second quarter of fiscal 2011.

19 Oct 2010

Clinical Trial News and Research

Genzyme reports results of Clolar combination Phase 3 trial in adult AML

IRB approves CEL-SCI’s Multikine Phase III clinical trial for head and neck cancer

Arena reports results of APD916 Phase 1 clinical trial for narcolepsy with cataplexy

European Commission grants Ipsen's OBI-1 orphan drug status for treatment of hemophilia

LANL's researcher to implement first human trial of mosaic HIV vaccine candidate

Retina Implant's first clinical trial results presented at 2010 AAO annual meeting

Highlights of world's largest ophthalmic education conference

Neuralstem updates Phase I human clinical trial of spinal cord stem cells for ALS

UTHSC-Houston initiates enrollment in NanoLogix technology trial for detection of GBS in pregnant women

UH researchers to explore role of Vitamin D in esophageal cancer prevention

Particle Sciences enters licensing, technology agreement with Solubest

Japanese study finds proton beam therapy safe and effective for Stage I inoperable NSCLC

Adamis acquires prostrate drug candidates from Colby Pharmaceuticals

MannKind begins MKC1106-MT Phase 2 trial for advanced melanoma

Research paves way to understand the mechanism of leptin therapy to improve type 1 diabetes

European Commission grants orphan drug status to OBI-1 for hemophilia treatment

Ceregene commences enrollment in CERE-120 Phase 2b study for Parkinson's disease

Anticoagulant Pradaxa receives FDA approval for prevention of stroke in atrial fibrillation patients

BioMarin announces BMN-111 program for treatment of achondroplasia

Forest Laboratories second quarter net sales increase 7.7% to $1,037.3 million

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