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Positive results obtained from phase 3 clinical trial of lurasidone for treating schizophrenia

Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from PEARL 2 - a phase 3 clinical trial of lurasidone for the treatment of patients with schizophrenia. In this trial, both lurasidone 40 and 120 mg/day were significantly more effective than placebo for the treatment of schizophrenia. Lurasidone was well-tolerated with an overall discontinuation rate that was similar to placebo.

26 Aug 2009

Alvine Pharmaceuticals commences Phase 2a clinical trial to evaluate the efficacy of ALV003

Alvine Pharmaceuticals, Inc. today announced that patient enrollment has begun in a Phase 2a, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of ALV003 for use in the treatment of celiac disease.

26 Aug 2009

Venlafaxine alleviates depressive symptoms

The Institute for Quality and Efficiency in Health Care (IQWiG) was commissioned by the Federal Joint Committee (G-BA) to investigate whether patients with depression benefit from taking drugs belonging to the selective serotonin and norepinephrine reuptake inhibitor (SNRI) drug class.

25 Aug 2009

Regado Biosciences to commence Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system

Regado Biosciences, Inc, a privately held company leading the development of antithrombotic therapeutic aptamers with active control agents, today announced enrollment of the first patient in the first Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system.

25 Aug 2009

Comparative effectiveness: Back surgery remains popular despite poor study results

Studies have recently found that vertebroplasty - a type of back surgery in which cement is injected into the spine - isn't effective, but many patients and their doctors insist it works.

25 Aug 2009

Retigabine's Phase IIa clinical trial preliminary results announced

Valeant Pharmaceuticals International today announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles.

24 Aug 2009

Phase 2 clinical study of Resolvin RX-10045 for dry eye syndrome provides positive data

Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced positive data from a Phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome.

24 Aug 2009

FDA issues complete response letter regarding the NDA for carisbamate

The U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for carisbamate, an anti-epileptic drug in development, announced Ortho-McNeil-Janssen Pharmaceuticals, Inc.

23 Aug 2009

Results of PCF funded study could impact the standard of care for prostate cancer patients

Twice-yearly intravenous infusion with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer. The report from an international research study, the first to document reduced fracture risk in men receiving the hormone-blocking treatment, was published today in the print edition of the New England Journal of Medicine (NEJM). Both fundamental research on rank ligand (RANKL) in prostate cancer bone metastasis and other molecular factors involved in the denosumab study were supported at Massachusetts General Hospital with funding from the Prostate Cancer Foundation (PCF).

21 Aug 2009

TCT Featured Clinical Trials to be presented on September 24 in San Francisco

A series of Featured Clinical Trials will be presented at Transcatheter Cardiovascular Therapeutics (TCT), in addition to late-breaking clinical trials. These featured clinical trials represent groundbreaking research and will yield data and insight that will further the field of interventional cardiology.

21 Aug 2009

RBC Life Sciences reports on patent-pending, nutritional supplement

RBC Life Sciences, Inc., a provider of proprietary nutritional supplements and wound care/pain management products, announced today the debut of NeuroBright(TM), a patent-pending, nutritional supplement that improved test subjects' learning and memory skills by 50 percent during a recent laboratory trial.

20 Aug 2009

Study unveils detrimental effects of high-dose ursodeoxycholic acid on patients with PSC

Primary sclerosing cholangitis (PSC) is an uncommon chronic liver disease characterized by progressive inflammation and destruction of the bile ducts. The disease progresses slowly, usually leading to biliary cirrhosis, portal hypertension and liver failure over a 10-15 year period. PSC is a common cause of adult cholestatic liver diseases and a primary source behind many of the liver transplantations in U.S. adults. At least 70% of PSC cases are associated with chronic inflammatory bowel disease (IBD), usually ulcerative colitis. Currently, there is no cure for PSC and prospective treatments remain ineffective.

20 Aug 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Arzoxifene phase 3 study results reported by Lilly

Eli Lilly and Company announced today that initial results from its pivotal, five-year, Phase III GJAD "GENERATIONS" trial for arzoxifene met its primary endpoints of significantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.

19 Aug 2009

Novavax reports positive preclinical results for H1N1 influenza VLP vaccine

Novavax, Inc. (Nasdaq: NVAX) announced positive preclinical results with Novavax's 2009 novel H1N1 influenza virus-like particle (VLP) vaccine. The study, conducted by scientists from Novavax and the Centers for Disease Control and Prevention (CDC) based in Atlanta, GA, under a collaborative agreement, represents the first efficacy report of a 2009 novel H1N1 vaccine in ferrets. The ferret model is widely accepted to be the most appropriate animal model for evaluating influenza disease and vaccines. Novavax scientists designed the vaccine using recombinant virus like particles (VLP) technology against an H1N1 virus strain (A/California/04/2009) isolated in the beginning of the 2009 H1N1 outbreak.

19 Aug 2009

CSL Biotherapies to supply Afluria influenza vaccines from newly licensed packaging facility

CSL Biotherapies, a subsidiary of CSL Limited, one of the world's leading manufacturers of influenza vaccine, announced today that the U.S. Food and Drug Administration (FDA) has licensed the company’s newest vaccine filling and packaging facility, located in Kankakee, Ill. The facility, part of an investment to expand CSL’s U.S. influenza vaccine production capabilities, includes a high-speed, single-dose vaccine syringe filling line.

19 Aug 2009

Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Forest Laboratories, Inc. (NYSE: FRX) and Glenmark Pharmaceuticals S.A. (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals India (GPL) today announced top-line results from a Phase IIb dose range-finding study of oglemilast in patients with Chronic Obstructive Pulmonary Disease (COPD). Once-daily treatment with oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is decreased in patients with COPD. Oglemilast was well tolerated at all doses studied.

19 Aug 2009

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Genentech, Inc. today announced that a Phase III study (RIBBON 2) of Avastin (bevacizumab) in combination with chemotherapy increased the time women with metastatic HER2-negative breast cancer whose initial chemotherapy had stopped working lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone.

18 Aug 2009

Aspirin improves survival after colorectal cancer diagnosis

Men and women who were diagnosed with colorectal cancer and began regular use of aspirin had a lower risk of overall and colorectal cancer death compared to patients not using aspirin, according to a study in the August 12 issue of JAMA.

18 Aug 2009

$Denosumab reduces fractures in postmenopausal women with osteoporosis$

Denosumab reduces fractures in postmenopausal women with osteoporosis

Fractures are a major cause of disability and health care costs among postmenopausal women. Now a study in the New England Journal of Medicine highlights an alternative therapy that prevents fractures in postmenopausal women with osteoporosis.

18 Aug 2009

Placebo News and Research

Positive results obtained from phase 3 clinical trial of lurasidone for treating schizophrenia

Alvine Pharmaceuticals commences Phase 2a clinical trial to evaluate the efficacy of ALV003

Venlafaxine alleviates depressive symptoms

Regado Biosciences to commence Phase I study of a subcutaneous administration formulation of the REG1 anticoagulation system

Comparative effectiveness: Back surgery remains popular despite poor study results

Retigabine's Phase IIa clinical trial preliminary results announced

Phase 2 clinical study of Resolvin RX-10045 for dry eye syndrome provides positive data

FDA issues complete response letter regarding the NDA for carisbamate

Results of PCF funded study could impact the standard of care for prostate cancer patients

TCT Featured Clinical Trials to be presented on September 24 in San Francisco

RBC Life Sciences reports on patent-pending, nutritional supplement

Study unveils detrimental effects of high-dose ursodeoxycholic acid on patients with PSC

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Arzoxifene phase 3 study results reported by Lilly

Novavax reports positive preclinical results for H1N1 influenza VLP vaccine

CSL Biotherapies to supply Afluria influenza vaccines from newly licensed packaging facility

Results of Phase IIb dose range finding of oglemilast in chronic obstructive pulmonary disease announced

Genentech announces Phase III study results for Avastin (bevacizumab) in combination with chemo in HER2-negative breast cancer

Aspirin improves survival after colorectal cancer diagnosis

Denosumab reduces fractures in postmenopausal women with osteoporosis

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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