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Medivation, Astellas enroll 1,199 patients in MDV3100 Phase 3 AFFIRM study in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced that patient enrollment was completed on November 15, 2010 in the Phase 3 AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy. The companies also announced that clinical development of MDV3100 in Japan has commenced, with the initiation of patient dosing in a Phase 1-2 clinical study.

30 Nov 2010

USPTO awards Immunitor key patent for viral vaccine

Immune Network Ltd., advises that its potential acquisition, Immunitor USA Inc., has been issued a key patent by the U.S. Patent and Trademark Office (USPTO).

29 Nov 2010

Amarin reports top-line results from AMR101 Phase 3 trial for treatment of high triglycerides

Amarin Corporation plc, a clinical-stage biopharmaceutical company with a focus on cardiovascular disease, today reported positive, statistically significant top-line results from the MARINE study, its first Phase 3 clinical trial of lead drug candidate AMR101.

29 Nov 2010

NovaBay announces meeting with FDA to discuss Aganocide compound for impetigo

NovaBay Pharmaceuticals, Inc., a clinical stage biotechnology company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, announces a successful meeting with the US Food and Drug Administration (FDA) to discuss the Company's clinical development of its Aganocide compound NVC-422, intended for use in the treatment of impetigo.

29 Nov 2010

Phase 3 trial: TYSABRI improves vision in MS patients

Results recently presented from a study of multiple sclerosis (MS) patients taking TYSABRI (natalizumab) are supported by a Canadian woman's improved vision since starting the therapy.

25 Nov 2010

FTC/TDF tablet reduces HIV infection among high-risk individuals: iPrEx study

In a finding with the potential to fundamentally change strategies to slow the global HIV epidemic, a new study called iPrEx shows that individuals at high risk for HIV infection who took a single daily tablet containing two widely used HIV medications, emtricitabine and tenofovir (FTC/TDF), experienced an average of 43.8% fewer HIV infections than those who received a placebo pill. New England Journal of Medicine, is the first evidence that this new HIV prevention method, called pre-exposure prophylaxis or PrEP, reduces HIV infection risk in people.

24 Nov 2010

GCM supports iPrEx Study to prevent HIV infection among MSM

The Global Campaign for Microbicides (GCM) welcomes today's news from the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Disease (NIAID) of the US National Institutes of Health (NIH) and the Gladstone Institutes of the University of California, San Francisco that daily use of oral emtricitabine (FTC) with tenofovir (TDF) in one tablet shows promise to safely and effectively help to prevent HIV infection among men who have sex with men (MSM).

24 Nov 2010

Important queries about PrEP, iPrEx trial for HIV infection

The results of the iPrEx PrEP effectiveness trial of once-daily TDF/FTC (brand name Truvada) in gay men, transgender women and other men who have sex with men are a landmark in HIV prevention research.

24 Nov 2010

HIV treatment drugs also help prevent HIV infection in high-risk men: Study

In a significant advance for HIV prevention research, a clinical trial confirms that the same drugs used for treating HIV can also help prevent HIV infection in the first place.

24 Nov 2010

iPrEx study: PrEP reduces HIV infection risk among gay, bisexual men

A daily dose of an oral antiretroviral drug, currently approved to treat HIV infection, reduced the risk of acquiring HIV infection by 43.8 percent among men who have sex with men.

24 Nov 2010

iPrEx trial shows reduction in new HIV infections

Results of the world's first efficacy trial of an HIV-prevention approach called oral pre-exposure prophylaxis, or PrEP, were released online in the New England Journal of Medicine today.

24 Nov 2010

iPrEx oral PrEP study achieves major milestone in HIV prevention research

This is a great day in the fight against AIDS. The positive results of the iPrEx oral PrEP study are a major milestone in HIV prevention research and provide important information about how antiretroviral drugs might be used for prevention by HIV-negative people at high risk for HIV infection, said AVAC Executive Director Mitchell Warren.

24 Nov 2010

Daily oral antiretroviral reduces HIV infection risk in MSM by 44%, study finds

A study that included nearly 2,500 HIV-negative men and transgender women who have sex with men has shown that a daily dose of Truvada, a pill containing the AIDS drugs emtricitabine and tenofovir, "can reduce risk of contracting [HIV] by an average of 44% - and by more than 70% if the subjects" follow the regimen closely, Los Angeles Times reports (Maugh, 11/23).

24 Nov 2010

Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

Combination of caffeine and glucose can improve cognitive performance: Study

The combination of caffeine and glucose can improve the efficiency of brain activity, according to a recent study in which functional magnetic resonance imaging was used to identify the neural substrate for the combined effects of these two substances.

23 Nov 2010

Botox Cosmetics increase overall quality of life and self-esteem

Chicago Facial Plastic Surgeon, Steven H. Dayan, MD, FACS, publishes a study in the November 2010 issue of Dermatologic Surgery, a prominent Dermatology journal, demonstrating that increases in overall quality of life and self-esteem were observed in participants treated with Botulinum Toxin Type A or Botox Cosmetic. In this double-blind randomized placebo-controlled survey, Dr. Dayan and DeNova research worked with one hundred participants who were treated with either Botox Cosmetic or a saline placebo for facial wrinkles.

23 Nov 2010

Hemispherx announces publication of Ampligen Phase III data in Journal of Applied Research

Hemispherx Biopharma, Inc., announced the publication of a peer-reviewed article providing new data on Ampligen [rintatolimod; poly(I)·poly(C12,U)], an experimental therapeutic in Phase III clinical testing, in the current issue of The Journal of Applied Research.

23 Nov 2010

Apricus files protocol of PrevOnco Phase 3 clinical trial for FDA SPA program

Apricus Biosciences, Inc., today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA).

23 Nov 2010

Omthera reaches agreement with FDA on SPA for Epanova Phase III trial in patients with very high triglycerides

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, today announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of its planned Phase III registration clinical trial of Epanova™, the Company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega 3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

22 Nov 2010

Neurocrine announces results from elagolix Phase II Daisy PETAL study in endometriosis

Neurocrine Biosciences, Inc. today announced results from the open-label portion of the six month Phase II Daisy PETAL study (901 study) using its proprietary, orally-active nonpeptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis.

22 Nov 2010