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Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Oncolytics Biotech Inc. today announced that it has received a No Objection Letter from Health Canada to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers.

19 Jul 2010

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Genetic Immunity, a US/Hungarian biopharmaceutical company developing nanomedicine-based immunotherapies for HIV/AIDS and other chronic diseases, is releasing Phase II data on the Company's novel DermaVir therapeutic vaccine for HIV/AIDS during the XVIII International AIDS Conference this week in Vienna, Austria. DermaVir, the first dendritic cell-targeting topical HIV vaccine candidate, employs nanotechnology to induce multi-faceted and long-lived immune responses capable of eliminating HIV infected cells.

19 Jul 2010

Pacific Shore releases clinical trial results for Burner Balm lip balm

Pacific Shore Holdings, Inc., today announced the release of the highly anticipated clinical trial results for Burner Balm lip balm. According to lead clinical investigator, Dr. David E. Toomey, who has orchestrated a multitude of clinical trials for some of the top pharmaceutical manufacturers in the United States, "Over a twelve week period, 120 study participants who were overweight participated in the study. The Burner Balm group lost an average of 7 to 9 pounds versus the placebo group who lost an average of 1.43 to 1.64 pounds in the 12 week period.

17 Jul 2010

MPI reduces depressive symptoms: Study

This randomized controlled trial aimed to evaluate the effectiveness of a nurse-led minimal psychological intervention (MPI) in chronically ill elderly persons with minor depression or mild-to-moderate major depression, and type II diabetes or chronic obstructive pulmonary disease. Nine months after the intervention, patients receiving the MPI showed a 50% reduction in depressive symptoms relative to baseline values and diabetic MPI patients had a better quality of life than diabetic controls.

16 Jul 2010

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS (pioglitazone HCl) offers an established safety profile regarding the risk of CV events in people living with type 2 diabetes.

16 Jul 2010

American Heart Association comments on FDA advisory committee's rosiglitazone recommendations

After two days of hearings, an advisory committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA allow the type 2 diabetes drug rosiglitazone (brand name, Avandia), to stay on the market, but with most committee members suggesting that the label be revised to include increased warnings. Rosiglitazone is one in a class of drugs called thiazolidinediones (TZDs), used to treat type 2 diabetes.

15 Jul 2010

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

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

15 Jul 2010

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

15 Jul 2010

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

ISTA Pharmaceuticals, Inc., today announced it has initiated a Phase 1/2 clinical study of bepotastine besilate nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. The randomized, placebo-controlled, parallel-group study will evaluate the safety and efficacy of three concentrations of bepotastine besilate, dosed twice daily, in an Environmental Exposure Chamber model of allergic rhinitis caused by natural exposure to seasonal allergens.

14 Jul 2010

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

Presidio Pharmaceuticals, Inc. announced today the successful completion of a Phase 1a clinical trial of PPI-461, its lead HCV NS5A inhibitor, in healthy subjects. This first-in-human trial evaluated four single doses of PPI-461, followed by a five-day, once-a-day treatment regimen with PPI-461 at the highest tested dose.

14 Jul 2010

New research studies presented at Alzheimer's Association International Conference

The primary therapeutic target in Alzheimer's disease has been the beta amyloid peptide, which clusters outside cells in the brain to form sticky clumps known as plaques. Recently, more attention has been given to the tau protein, which aggregates inside the brain cells of people with Alzheimer's, forming neurofibrillary tangles. Precisely how these proteins interact in causing the disease is unclear.

14 Jul 2010

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

Supernus Pharmaceuticals, Inc. today announced the initiation of a Phase IIa U.S. clinical trial of its product candidate SPN812 for the treatment of ADHD in adults. The trial is a proof-of-concept, randomized, double-blind, placebo-controlled study in healthy adults aged 18 to 64, inclusive, with ADHD. Supernus expects to enroll 50 subjects in the study at 5 sites across the United States.

14 Jul 2010

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

A new Australian drug has been shown to assist in protecting patients with a rare genetic disorder that makes their skin toxic to light and UV, and previously forced them to live in the shadows.

13 Jul 2010

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Innocoll, Inc. announced that its wholly-owned subsidiary, Innocoll Technologies Ltd., has submitted a Special Protocol Assessment (SPA) for a proposed phase 3 clinical trial to support the U.S. approval of Cogenzia™: Innocoll's topical antibiotic therapy for the adjuvant treatment of infected diabetic foot ulcers.

13 Jul 2010

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

BioSante Pharmaceuticals, Inc. today announced the initiation of a LibiGel (testosterone gel) clinical trial to evaluate its effect on cognitive function in menopausal women. The trial is a randomized, 6-month comparison of the effect of LibiGel compared to placebo treatment on a variety of learning and memory tasks. The study is being conducted by Dr. Susan Davis, Professor of Women's Health, Department of Medicine, Monash University Women's Health Program in Australia.

13 Jul 2010

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract, SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia.

13 Jul 2010

Jellyfish protein may help cognitive function in Alzheimer’s

Quincy Bioscience, a research-based biotechnology company, is attending the annual Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD) sharing promising interim data from the Madison Memory Study, a randomized controlled trial, which shows the jellyfish protein apoaequorin improves cognitive function in individuals with memory concerns.

13 Jul 2010

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

Cumberland Pharmaceuticals Inc. today announced that data supporting the efficacy of Caldolor in treating fever associated with falciparum malaria was published in the July edition of the peer-reviewed American Journal of Tropical Medicine and Hygiene. The study, which is the first to document an antipyretic effect of an injectable non-steroidal anti-inflammatory drug on fever caused by malaria, demonstrated that patients who received intravenous ibuprofen experienced a greater reduction in their temperatures than those who received placebo.

13 Jul 2010

New research evaluates effectiveness of popular slimming supplements

New research evaluating the effectiveness of a broad selection of popular slimming supplements sold in pharmacies and health food shops has found no evidence that any of them facilitate weight loss beyond the placebo effect.

12 Jul 2010

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

A second-generation experimental anti-obesity and diabetes drug has shown promise in reducing body weight in rodents just as effectively as the predecessor rimonabant while avoiding the risk of psychiatric side effects that led to the withdrawal of rimonabant from the market and stopped further development of other brain-penetrating drugs of its type.

12 Jul 2010

Placebo News and Research

Oncolytics Biotech receives Canadian approval for combination REOLYSIN Phase 3 trial in head, neck cancer

Phase II data on Genetic Immunity's DermaVir vaccine to be presented at XVIII International AIDS Conference

Pacific Shore releases clinical trial results for Burner Balm lip balm

MPI reduces depressive symptoms: Study

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

American Heart Association comments on FDA advisory committee's rosiglitazone recommendations

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

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Phase 1/2 clinical study of bepotastine besilate nasal spray initiated for seasonal allergic rhinitis

Presidio Pharmaceuticals completes Phase 1a clinical trial of PPI-461 in healthy subjects

New research studies presented at Alzheimer's Association International Conference

Supernus initiates SPN812 Phase IIa clinical trial for ADHD in adults

SCENESSE reduces, prevents phototoxic reactions experienced by EPP patients in Phase III trial

Innocoll submits SPA for phase 3 clinical trial of Cogenzia for adjuvant treatment of infected diabetic foot ulcers

Clinical trial initiated to evaluate LibiGel on cognitive function in menopausal women

SPET-085 is effective in blocking critical enzyme that leads to BPH: Study

Jellyfish protein may help cognitive function in Alzheimer’s

Efficacy data of Caldolor Injection in treating fever associated with falciparum malaria published

New research evaluates effectiveness of popular slimming supplements

Experimental anti-obesity and diabetes drug avoids risk of psychiatric side effects: Study

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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