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New York Times examines HIV prevention products undergoing clinical trials

The New York Times examines several products being studied in clinical trials that researchers hope will one day prevent sexual transmission of HIV. The newspaper describes the ongoing trials of a vaginal microbicide gel containing the antiretroviral tenofovir which was found to reduce the risk of HIV infection in women by 39 percent, writing, "[o]ther clinical trials will report their results in 2011 and 2012 and, if all goes well, researchers hope to have a product or two ready to enter the market by 2013."

10 Nov 2010

Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the second Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational candidate vaccine being developed to treat nicotine addiction and prevent smoking relapse.

10 Nov 2010

Phytomedics awarded $244,000 QTDP grant for development of RA drug

Phytomedics, Inc., a transformational healthcare company developing a novel portfolio of drugs and consumer products solely derived from plant sources, announced today that it has been awarded a grant in the amount of $244,000 under the Qualifying Therapeutic Discovery Project (QTDP) Program to advance the development of its lead product PMI-001 for Rheumatoid Arthritis. PMI-001 is presently in Phase 2b/3 development.

9 Nov 2010

NeuroDerm commences enrollment in ND0801 Phase 2a clinical study of ADD/ADHD in adults

NeuroDerm, Ltd. announced today that patient enrollment has begun in a Phase 2a clinical study of ND0801, a new product for the treatment of Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder (ADD/ADHD) in adults. ND0801, based on a new, proprietary combination with nicotinic actions, is being developed as a dermal patch and will be evaluated for the treatment of cognitive impairment in several disorders including Alzheimer's disease, schizophrenia and advanced Parkinson's disease, among others.

9 Nov 2010

EntreMed to present data of ENMD-2076 Phase 1 study in multiple myeloma and leukemia at ASH 2010

EntreMed, Inc., a clinical-stage pharmaceutical company developing therapeutics for the treatment of cancer, today announced presentations for its Phase 2 oncology drug candidate, ENMD-2076. Data for the ENMD-2076 Phase 1 studies in multiple myeloma and leukemia will be presented by EntreMed investigators at the 2010 Annual Meeting of the American Society of Hematology (ASH) to be held December 4-7 at the Orange County Convention Center in Orlando, Florida.

9 Nov 2010

Discovery Labs reports net operating loss of $6.2 million for third quarter 2010

Discovery Laboratories, Inc., a biotechnology company developing its novel, synthetic, peptide-containing surfactant and related aerosolization technologies as first in class therapies for severe respiratory diseases, today provides an update on key pipeline and business initiatives and a financial update for the third quarter ended September 30, 2010.

9 Nov 2010

Arena and Eisai report positive results from lorcaserin BLOOM-DM trial in obese, overweight diabetics

Arena Pharmaceuticals, Inc. and Eisai Inc. reported today that top-line results from the one-year lorcaserin BLOOM-DM trial demonstrate statistically significant weight loss in obese and overweight patients with type 2 diabetes. In this trial, lorcaserin met all three co-primary efficacy endpoints. In addition, as described below, lorcaserin patients taking lorcaserin 10 mg twice daily (BID) achieved statistically significant improvements in multiple secondary endpoints, including HbA1c, as compared to patients randomized to placebo.

9 Nov 2010

Arena third quarter net loss increases to $36.3 million

Arena Pharmaceuticals, Inc. today reported financial results for the third quarter ended September 30, 2010. Arena also reported earlier today top-line results from its lorcaserin Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial.

9 Nov 2010

ORAL Solo Phase 3 study shows tasocitinib reduces signs and symptoms of active RA

Pfizer Inc. today announced results of ORAL Solo (1045), a Phase 3 study that showed tasocitinib (CP-690,550), an investigational, novel, oral JAK inhibitor, administered as monotherapy met two primary endpoints, demonstrating a statistically significant reduction in signs and symptoms of moderately to severely active rheumatoid arthritis (RA) and improvement in physical function as measured by ACR20 response rates and mean change in HAQ-DI, respectively, versus placebo at three months.

9 Nov 2010

ORVACS launches ERAMUNE 01 Phase II study to decrease HIV viral reservoirs

ORVACS has launched a Phase II study designed to test the hypotheses that combination therapy with potent antiviral agents and immunomodulator can lead to a decrease in the HIV viral reservoirs and, ultimately, to eradication of the virus. The study is currently being conducted at clinical sites in France, Spain, Italy, and the United Kingdom.

9 Nov 2010

Seattle Genetics, Millennium to feature SGN-35 in two oral presentations at ASH Annual Meeting

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited today announced that brentuximab vedotin (SGN-35) will be featured in two oral presentations at the 52nd American Society of Hematology (ASH) Annual Meeting and Exposition being held December 4-7, 2010 in Orlando, FL.

9 Nov 2010

Inspiration receives two grants under QTDP program to advance development of IB1001, OBI-1 products

Inspiration Biopharmaceuticals, Inc. today announced the Company was awarded two grants, totaling $488,958, under the Qualifying Therapeutic Discovery Projects Grant Program (QTDP).

9 Nov 2010

EVP-6124 receptor acts as co-agonist with ACh to enhance cognition

EnVivo Pharmaceuticals today announced it has discovered that EVP-6124, its alpha-7 nicotinic acetylcholine receptor agonist, possesses a novel mechanism not previously seen in the scientific community: it acts as a co-agonist with Acetylcholine (ACh) to enhance cognition.

9 Nov 2010

Colcrys safe for treating gout flares

Patients who experience gout flares can be treated safely with Colcrys (colchicine, USP), even in the presence of co-morbid conditions that often present physicians with treatment challenges, according to a new analysis presented here at the 74th Annual Scientific Meeting of the American College of Rheumatology (ACR).

9 Nov 2010

Genta commences tesetaxel Phase 2b clinical trial as 1st-line chemotherapy for metastatic breast cancer

Genta Incorporated today announced that the Company has initiated a new Phase 2b clinical trial of tesetaxel as 1st-line chemotherapy for women with metastatic breast cancer. Tesetaxel is the leading oral taxane currently in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY and at the Accelerated Community Oncology Research Network (ACORN) based in Memphis, TN.

9 Nov 2010

SIMPONI injection improves inflammation, structural damage in RA patients

Magnetic resonance imaging (MRI) analyses from two Phase 3 clinical trials showed that once every four week subcutaneous injections of SIMPONI (golimumab) 50 mg plus methotrexate resulted in statistically significant improvements in markers of inflammation and structural damage in patients with active rheumatoid arthritis (RA) compared with placebo plus methotrexate.

9 Nov 2010

Merrimack receives $2.44 million under QTDP program to support cancer research

Merrimack Pharmaceuticals was awarded $2.44 million to support research on 10 of its cancer programs through the Qualifying Therapeutic Discovery Project, a grant program created as part of the Patient Protection and Affordable Care Act of 2010 to advance research in areas of unmet medical need.

9 Nov 2010

Dabigatran etexilate benefits AF patients with previous stroke or transient ischemic attack

Today, The Lancet Neurology published positive results from a sub-group analysis of the landmark Randomized Evaluation of Long-Term Anticoagulant Therapy (RE-LY®) trial - the largest atrial fibrillation (AF) outcomes trial ever completed (18,113 patients in 44 countries worldwide). The new findings fully support the convincing results from the RE-LY® trial and show that AF patients with previous stroke or transient ischemic attack (TIA) may benefit substantially from treatment with dabigatran etexilate.

9 Nov 2010

EpiCept third quarter net loss decreases to $3.2 million

EpiCept Corporation today announced operating and financial results for the three and nine months ended September 30, 2010, and provided an update with respect to the Company's key business initiatives.

9 Nov 2010

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

BioCryst Pharmaceuticals, Inc. announced the presentation of new data related to the efficacy and safety of BCX4208 for the treatment of gout at the 74th ACR Scientific Meeting being held in Atlanta, Georgia.

9 Nov 2010

Drug Trial News

New York Times examines HIV prevention products undergoing clinical trials

Enrollment complete in Nabi's second NicVAX Phase III clinical trial for nicotine addiction

Phytomedics awarded $244,000 QTDP grant for development of RA drug

NeuroDerm commences enrollment in ND0801 Phase 2a clinical study of ADD/ADHD in adults

EntreMed to present data of ENMD-2076 Phase 1 study in multiple myeloma and leukemia at ASH 2010

Discovery Labs reports net operating loss of $6.2 million for third quarter 2010

Arena and Eisai report positive results from lorcaserin BLOOM-DM trial in obese, overweight diabetics

Arena third quarter net loss increases to $36.3 million

ORAL Solo Phase 3 study shows tasocitinib reduces signs and symptoms of active RA

ORVACS launches ERAMUNE 01 Phase II study to decrease HIV viral reservoirs

Seattle Genetics, Millennium to feature SGN-35 in two oral presentations at ASH Annual Meeting

Inspiration receives two grants under QTDP program to advance development of IB1001, OBI-1 products

EVP-6124 receptor acts as co-agonist with ACh to enhance cognition

Colcrys safe for treating gout flares

Genta commences tesetaxel Phase 2b clinical trial as 1st-line chemotherapy for metastatic breast cancer

SIMPONI injection improves inflammation, structural damage in RA patients

Merrimack receives $2.44 million under QTDP program to support cancer research

Dabigatran etexilate benefits AF patients with previous stroke or transient ischemic attack

EpiCept third quarter net loss decreases to $3.2 million

BioCryst to present data on BCX4208 for gout at ACR Scientific Meeting

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