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Synageva's SBC-102 enzyme replacement therapy for LAL deficiency granted European orphan product designation

Synageva BioPharma Corp., a privately held biopharmaceutical company, announced that the European Medicines Agency (EMA) granted orphan product designation for SBC-102 (Recombinant Human Lysosomal Acid Lipase), the Company's enzyme replacement therapy in development to treat Lysosomal Acid Lipase (LAL) Deficiency.

10 Nov 2010

BioInvent receives FDA IND clearance for BI-204 Phase II trial in cardiovascular disease

BioInvent International AB today announces IND clearance from the U.S. Food & Drug Administration (FDA) to initiate a Phase II study for BI-204. BI-204 is a human monoclonal antibody that specifically targets oxidized forms of a low-density lipoprotein (LDL) which has been linked to increased inflammatory processes leading to plaque formation in the blood vessel walls. BI-204 is being co-developed with Genentech for secondary prevention of cardiovascular events in patients with acute coronary syndrome (ACS).

10 Nov 2010

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

TONIX Pharmaceuticals (formerly known as Krele Pharmaceuticals), a specialty central nervous system (CNS) pharmaceutical company, announced results of a new analysis of a Phase 2a study, which previously demonstrated reduced pain, fatigue and tenderness in patients with Fibromyalgia Syndrome (FMS) following bedtime administration of very low dosage (VLD) cyclobenzaprine (CBP).

10 Nov 2010

Silence Therapeutics' Atu027 RNAi drug prevents pulmonary metastasis formation

Silence Therapeutics plc announces positive research findings demonstrating the ability of the Company's lead RNA interference (RNAi) drug candidate, Atu027, to prevent the formation of pulmonary metastasis in various animal models of cancer metastasis. Researchers showed that Atu027 inhibited multiple key biological processes that enable and contribute to the dissemination and formation of pulmonary metastases in a murine breast cancer metastasis model.

10 Nov 2010

Diamyd completes patient screening for DiaPrevent Phase III study

Diamyd Medical has completed the screening of patients for the US Phase III study, DiaPrevent, ending the recruitment campaign. More than 310 recently diagnosed type 1 diabetes patients between 10 and 20 years of age have already been enrolled in the study and have received their first injection of the antigen-based therapy Diamyd® or placebo.

10 Nov 2010

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

Drug Trial News

Synageva's SBC-102 enzyme replacement therapy for LAL deficiency granted European orphan product designation

BioInvent receives FDA IND clearance for BI-204 Phase II trial in cardiovascular disease

TONIX Pharmaceuticals announces Phase 2a study results of cyclobenzaprine in Fibromyalgia Syndrome

Silence Therapeutics' Atu027 RNAi drug prevents pulmonary metastasis formation

Diamyd completes patient screening for DiaPrevent Phase III study

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

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

How GLP‑1 Agonists Are Shaping the Future of Obesity Treatment With Dr Bryony Henderson

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