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FDA accepts, files Genentech's sBLA for subcutaneous use of Xolair in people with CIU

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted and filed the company's supplemental Biologics License Application for subcutaneous use of Xolair (omalizumab) in people with Chronic Idiopathic Urticaria who remained symptomatic despite treatment with H1-antihistamine therapy at approved doses.

11 Oct 2013

Researchers explore effects of soy, whey protein supplementation on hormonal responses to resistance exercise

A group of researchers recently expanded upon the limited prior research examining the effects of soy and whey protein supplementation on testosterone, sex hormone binding globulin (SHBG), and cortisol responses to an acute bout of resistance exercise.

11 Oct 2013

Adding danoprevir to treatment regimen for hepatitis C patients leads to high rates of remission

The addition of danoprevir to the current treatment regimen for patients with hepatitis C leads to high rates of remission, according to a new article in Gastroenterology, the official journal of the American Gastroenterological Association.

11 Oct 2013

Teva Cutting 5,000 Jobs In Global Restructuring

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10 Oct 2013

Transcendental Meditation technique has large effect on reducing trait anxiety, shows analysis

A new meta-analysis published today in the Journal of Alternative and Complementary Medicine (2013;19(10):1-12)1 found the Transcendental Meditation- technique (TM) has a large effect on reducing trait anxiety for people with high anxiety.

10 Oct 2013

Phase 3 study of idelalisibin reports positive results in CLL patients

Following a recommendation by an independent Data Monitoring Committee (DMC), Gilead Sciences, Inc. (Nasdaq:GILD) today announced that its Phase 3 study (Study 116) evaluating idelalisib in previously-treated chronic lymphocytic leukemia (CLL) patients who are not fit for chemotherapy will be stopped early.

10 Oct 2013

Lundbeck, Otsuka to continue development of Lu AE58054 compound for Alzheimer's disease

H. Lundbeck A/S and Otsuka Pharmaceutical Co., Ltd. announced today the continuation of the development program of Lu AE58054 for the treatment of Alzheimer's disease, initiating the first out of four phase III clinical trials with the compound.

10 Oct 2013

Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis

Pfizer Inc. announced today top-line results from two Phase 3 clinical trials of tofacitinib, a novel, oral Janus kinase inhibitor that is being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis: OPT Compare (A3921080) and OPT Retreatment (A3921111).

10 Oct 2013

Adempas drug gets FDA approval for treatment of pulmonary hypertension

The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs.

10 Oct 2013

Study proposes novel treatment for narcolepsy

Lancet Neurology, a prestigious journal in its domain, publishes in its last issue, an article entitled "Pitolisant versus placebo and modafinil in patients with narcolepsy: a double-blind randomised trial" authored by Y. Dauvilliers and others from the HARMONY I study group which proposes a novel treatment for this orphan disease. It is accompanied by a Commentary entitled "A need for new treatments in narcolepsy".

10 Oct 2013

Promedior starts Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis

Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, announced today that it has initiated a Phase 2 clinical trial to evaluate PRM-151, its lead product candidate, in patients with myelofibrosis.

10 Oct 2013

New HIV vaccines stimulate critical immune response in infants born to HIV-infected mothers

A new analysis of two HIV vaccine trials that involved pediatric patients shows that the investigational vaccines stimulated a critical immune response in infants born to HIV-infected mothers, researchers at Duke Medicine report.

9 Oct 2013

EGS announced that enrollment for RESPECT study has surpassed company's original target

EndoGastric Solutions (EGS), the leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), announced today that enrollment for the RESPECT study (Randomized EsophyX vs. Sham/Placebo Controlled Trial) is complete and has surpassed the company's original target of 120 patients.

9 Oct 2013

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening.

9 Oct 2013

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Alkermes plc (NASDAQ: ALKS) today announced completion of patient enrollment in the pivotal, multinational phase 3 study evaluating aripiprazole lauroxil in patients with schizophrenia.

9 Oct 2013

Arrowhead initiates Phase 1 study of ARC-520 for treatment against chronic HBV infection

Arrowhead Research Corporation (NASDAQ: ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today announced that it completed enrollment in a Phase 1 clinical trial of ARC-520, its RNAi-based candidate against chronic hepatitis B virus infection.

9 Oct 2013

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the first patient has been enrolled in the second clinical trial of Glial Growth Factor 2 (GGF2). This Phase 1b single-infusion trial in people with heart failure will assess tolerability of three dose levels of GGF2, and also includes several explorative measures of efficacy.

9 Oct 2013

Study: Effect of medication treatments on patients with alcoholism and anxiety

Domenic Ciraulo, MD, chair of psychiatry at Boston University School of Medicine (BUSM) and David H. Barlow, PhD, professor of psychology at Boston University (BU), have collaborated to study the effect of behavioral and medication treatments on patients with alcoholism and anxiety.

8 Oct 2013

Researchers examine probiotics to prevent excessive crying in infants

There still appears to be insufficient evidence to support using probiotics (Lactobacillus reuteri) to manage colic or to prevent crying in infants, especially in formula-fed babies, but it may be an effective treatment for crying infants who are breastfed exclusively and have colic, according to a study by Valerie Sung, M.P.H., of the Murdoch Childrens Research Institute and Royal Children's Hospital, Australia, and colleagues.

8 Oct 2013

AbbVie announces HUMIRA phase II study results for treating hidradenitis suppurativa

AbbVie (NYSE: ABBV) today announced results from a post-hoc analysis of an investigational Phase II study, which evaluated HUMIRA® (adalimumab) in the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS) after 16 weeks of therapy.

7 Oct 2013

Placebo News and Research

FDA accepts, files Genentech's sBLA for subcutaneous use of Xolair in people with CIU

Researchers explore effects of soy, whey protein supplementation on hormonal responses to resistance exercise

Adding danoprevir to treatment regimen for hepatitis C patients leads to high rates of remission

Teva Cutting 5,000 Jobs In Global Restructuring

Transcendental Meditation technique has large effect on reducing trait anxiety, shows analysis

Phase 3 study of idelalisibin reports positive results in CLL patients

Lundbeck, Otsuka to continue development of Lu AE58054 compound for Alzheimer's disease

Pfizer reports positive results from two tofacitinib Phase 3 trials for chronic plaque psoriasis

Adempas drug gets FDA approval for treatment of pulmonary hypertension

Study proposes novel treatment for narcolepsy

Promedior starts Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis

New HIV vaccines stimulate critical immune response in infants born to HIV-infected mothers

EGS announced that enrollment for RESPECT study has surpassed company's original target

Bayer HealthCare receives FDA approval for Adempas tablets

Alkermes completes patient enrollment in phase 3 study of aripiprazole lauroxil in schizophrenia patients

Arrowhead initiates Phase 1 study of ARC-520 for treatment against chronic HBV infection

Acorda Therapeutics initiates second clinical trial of Glial Growth Factor 2 in heart failure patients

Study: Effect of medication treatments on patients with alcoholism and anxiety

Researchers examine probiotics to prevent excessive crying in infants

AbbVie announces HUMIRA phase II study results for treating hidradenitis suppurativa

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