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Taiho receives CHMP positive opinion on Teysuno in combination with cisplatin for advanced gastric cancer

Taiho Pharmaceutical Co., Ltd., and its parent company, Otsuka Holdings Co., Ltd., announced today that the Committee for Medicinal Products for Human Use (CHMP), a division of the European Medicines Agency (EMA), has issued an opinion recommending approval of Teysuno™ (S-1), a novel oral anti-cancer agent, intended for the treatment of advanced gastric cancer in adults when given in combination with cisplatin.

17 Dec 2010

City Tech Nursing Professor provides community-based care plan to study difference in health outcomes

Patients with diabetes who follow a self-care regimen generally have success in controlling their disease. But what about patients whose other health conditions, such as cognitive impairment and/or depression, create barriers to effective treatment?

17 Dec 2010

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

Repros Therapeutics Inc. today announced it has commenced preparation for dosing the 3 mg cohort in the Company's low dose study of Proellex® following a safety review of data from women that have completed 8 weeks of treatment at a 1 mg dose. No signals of liver toxicity were detected to date in the 1 mg group. Unexpectedly, low levels of drug activity were detected in this first cohort. The Company plans to commence dosing of the second group, 3 mg Proellex, next week.

17 Dec 2010

Bayer's SAFYRAL oral contraceptive receives FDA approval

Bayer HealthCare Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved a new oral contraceptive (OC), SAFYRAL™ (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets). In women who choose an OC for birth control, SAFYRAL raises folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking SAFYRAL or shortly after discontinuing it.

17 Dec 2010

Health law challenges shift to Florida courtroom

Today marks a "new day in court" as oral arguments will be heard in a Florida courtroom regarding the 20-state legal challenge. This lawsuit includes issues surrounding the health law's individual mandate and Medicaid expansions. Meanwhile, analysis continues regarding Monday's decision by a federal court judge in Virginia and a new round of debate regarding whether the health overhaul lawsuits bring to light issues of judicial bias.

16 Dec 2010

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

Anacor Pharmaceuticals announced today that enrollment has been initiated and the first patient has been dosed in the Phase 3 program of AN2690, a topical antifungal product candidate for the treatment of onychomycosis.

16 Dec 2010

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Manhattan Pharmaceuticals, Inc. announced preliminary results today from a Phase 1/2 study of AST-915 for the treatment of essential tremor. Data from this single dose study demonstrated that AST-915 was safe and well tolerated and demonstrated a clear effect on tremor power.

16 Dec 2010

Adeona expands and enhances zinc-based product candidate portfolio

Adeona Pharmaceuticals, Inc., a developer of innovative medicines for serious central nervous system diseases, announced today that it has acquired access to clinical data supporting a zinc-based therapy for the prevention of infections in the elderly. This acquisition expands and enhances Adeona's zinc-based product candidate portfolio that already includes its proprietary zinc-based tablets for use in the dietary management of mild to moderate Alzheimer's disease and mild cognitive impairment patients, and age-related macular degeneration.

16 Dec 2010

Pico-Tesla commences pilot study of Magneceutical Therapy in fibromyalgia patients

Pico-Tesla, The Magneceutical® Company, announced that it has commenced a randomized, double-blind, placebo-controlled pilot study of 30 patients who have fibromyalgia. The pilot study seeks to determine whether the application of magnetic fields generated by Pico-Tesla's patented Resonator™ system can be effective as an adjunctive therapy to oral medications in ameliorating the symptoms of fibromyalgia.

16 Dec 2010

ADA supports FDA panel's recommendation for continuing review of existing, new scientific information

The American Dental Association today praised a Food and Drug Administration advisory panel's finding that the FDA acted appropriately when it ruled last year that dental amalgam is a safe and effective treatment option for the general population.

16 Dec 2010

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

CEL-SCI Corporation announced today it has received governmental approval from the Health Authority, Ministry of Health of Ukraine, to begin enrollment of subjects for a Phase III clinical trial of Multikine® in Ukraine. Multikine is the Company's flagship immunotherapy developed as a first-line standard of care in treating head and neck cancer. Ukraine is one of nine countries to participate in this global Phase III trial. The Phase III trial will be run at about 48 clinical centers, of which about 6 centers will be in Ukraine.

16 Dec 2010

Use of vitamin K antagonists is driven by availability of oral formulation

Arlington Medical Resources (AMR), a provider of premier market intelligence for the pharmaceutical and diagnostic imaging industries, finds that, in the treatment of atrial fibrillation, surveyed European cardiologists indicate that use of vitamin K antagonists, as a class, is primarily driven by the availability of an oral formulation, overall low cost and widespread inclusion on European medical society guidelines and hospital formularies.

16 Dec 2010

Inhaled corticosteroids may cause diabetes

In a study published in the most recent issue of The American Journal of Medicine, researchers found that inhaled corticosteroids were associated with a 34% increase in the rate of diabetes onset and in the rate of diabetes progression. At the highest inhaled doses the risk increased by 64% in diabetes onset and 54% in diabetes progression.

15 Dec 2010

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Drug addiction investigators with joint appointments at Columbia University Medical Center and the New York State Psychiatric Institute along with MediciNova Inc, a biopharmaceutical company publicly traded on the Nasdaq Global Market and the Jasdaq Market of the Osaka Securities Exchange, today reported preliminary results of the company's neurological drug candidate, ibudilast (MN-166/AV411), in a Phase 1b/2a trial in opioid addicts. The study was largely funded by the National Institute on Drug Abuse (NIDA) with MediciNova supplementation.

14 Dec 2010

Unigene enters agreement with GSK to advance oral PTH Phase 2 program for osteoporosis

Unigene Laboratories, Inc. today announced that the Company entered into an amended and restated exclusive worldwide license agreement with GlaxoSmithKline (GSK) to develop and commercialize an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women and plans to initiate a Phase 2 study in the first quarter of 2011.

14 Dec 2010

Scientists discover new way in which HPV triggers cancer

University of Manchester scientists have discovered for the first time an important new way in which the human papilloma virus (HPV) triggers cancer in what could lead to new treatments for cervical and mouth cancer.

14 Dec 2010

Scientists perform metagenomic analysis of bacterial immune system for personalized oral health care

The human body is home to a complex ecosystem of microbes increasingly recognized as having a critical role in both health and disease.

14 Dec 2010

GTx announces Capesaris proof of concept clinical trail in men with advanced prostate cancer

BETHESDA, Md.,GTx, Inc. this weekend presented results of the Capesaris™ (GTx-758) proof of concept pharmacokinetic-pharmacodynamic (PK/PD) clinical trial at the Annual Meeting of the Society of Urologic Oncology.

14 Dec 2010

Even small amount of alcohol increases chances of developing cancer

When raising your glass at this year's holiday toast, choose your beverage wisely, say experts at The University of Texas MD Anderson Cancer Center. If adults wish to drink alcohol, they should select drinks low in calories and alcohol content to limit cancer risk.

14 Dec 2010

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced first-in-human Phase 1 clinical trial results for CMX157 demonstrating a favorable safety, tolerability and drug distribution profile.

14 Dec 2010

Oral News and Research

Taiho receives CHMP positive opinion on Teysuno in combination with cisplatin for advanced gastric cancer

City Tech Nursing Professor provides community-based care plan to study difference in health outcomes

Repros prepares for dosing 3 mg cohort in low dose Proellex study in uterine fibroids and endometriosis

Bayer's SAFYRAL oral contraceptive receives FDA approval

Health law challenges shift to Florida courtroom

Anacor Pharmaceuticals initiates AN2690 phase 3 program for onychomycosis fungal infection

Manhattan Pharmaceuticals reports preliminary results from AST-915 Phase 1/2 study in essential tremor

Adeona expands and enhances zinc-based product candidate portfolio

Pico-Tesla commences pilot study of Magneceutical Therapy in fibromyalgia patients

ADA supports FDA panel's recommendation for continuing review of existing, new scientific information

CEL-SCI receives Ukraine government approval for Multikine Phase III clinical trial in head and neck cancer

Use of vitamin K antagonists is driven by availability of oral formulation

Inhaled corticosteroids may cause diabetes

Preliminary results from Phase 1b/2a trial of MediciNova's ibudilast in opioid addicts announced

Unigene enters agreement with GSK to advance oral PTH Phase 2 program for osteoporosis

Scientists discover new way in which HPV triggers cancer

Scientists perform metagenomic analysis of bacterial immune system for personalized oral health care

GTx announces Capesaris proof of concept clinical trail in men with advanced prostate cancer

Even small amount of alcohol increases chances of developing cancer

Chimerix reports positive results from CMX157 Phase 1 clinical trial for HIV

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