Efficacy News and Research

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Data of focusing on Rebif and Cladribine Tablets to be presented at AAN Annual Meeting

EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, today announced that new data from the company's multiple sclerosis portfolio of approved and investigational treatments will be presented at the 62nd Annual Meeting of the American Academy of Neurology taking place April 10 to 17, in Toronto, Canada.

1 Apr 2010

Phase 1/2 human clinical trial of Symphogen's Sym004 initiated in the US

Symphogen A/S today announced that it has initiated a Phase 1/2 human clinical trial in the US to evaluate the safety, tolerability and efficacy of its drug candidate Sym004 for the treatment of advanced solid tumors. Sym004 is composed of two anti-epidermal growth factor receptor monoclonal antibodies targeting different nonoverlapping EGFR epitopes.

1 Apr 2010

Major breakthrough may help develop low toxicity drugs for sleeping sickness

Scientists from the Drug Discovery Unit at the University of Dundee - working together with partners at the University of York and the Structural Genomics Consortium in Toronto - have made a major breakthrough in identifying new treatments for a fatal disease which infects tens of thousands of Africans each year.

1 Apr 2010

Repros Therapeutics announces response to FDA critique on proposed Phase II Androxal study

Repros Therapeutics Inc. today announced that the Company is sending a reply to the FDA's Division of Metabolism and Endocrinology Products following the Company's receipt of FDA's comments on the proposed Phase II study of Androxal® (enclomiphene) in the treatment of Type II diabetes under Repros' open IND. On February 2, 2010 the Company announced that Repros received confirmation from the Agency that the new IND is effective.

1 Apr 2010

Positive results from Phase 2 clinical trial of OMS103HP

Omeros Corporation today announced that a Phase 2 clinical trial of OMS103HP, its PharmacoSurgery™ product candidate for arthroscopy, demonstrated that patients treated with OMS103HP during arthroscopic knee meniscectomy surgery achieved statistically significant clinical benefits.

1 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Tanda Professional Restore light therapy now made available for at-home use

During a press conference yesterday, doctors and experts unveiled a groundbreaking medical device using the healing properties of light therapy for pain management and improving mobility. For the first time ever, a licensed medical device that delivers clinical levels of light therapy only previously available in a doctor's office, has now been made available for at-home use.

1 Apr 2010

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Genta Incorporated today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development.

31 Mar 2010

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

ViroPharma Incorporated today announced that it has initiated an open-label, single-dose Phase 2 study to evaluate doses of Cinryze™ (C1 esterase inhibitor [human)] for treatment of acute angioedema attacks in children less than 12 years of age with hereditary angioedema.

31 Mar 2010

SANUWAVE Health reports net loss of $2.7M for three months ended December 31, 2009

SANUWAVE Health, Inc., an emerging medical technology company focused on regenerative medicine, reports its financial results for the fourth quarter and full year ended December 31, 2009, and on its progress for the year.

31 Mar 2010

DSMB for DIGNITY trial recommends Celsion continue enrollment

Celsion Corporation announced today that after reviewing safety data from the 40mg/m2 cohort, the DIGNITY Study Drug Safety Monitoring Board (DSMB) has recommended that Celsion continue to enroll patients in the trial and that new patients be treated at a ThermoDox® dose of 50mg/m2.

31 Mar 2010

ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

ArQule, Inc. today announced that ARQ 197, when used in combination with erlotinib, demonstrated a 66% improvement in median Progression-Free Survival in patients with advanced, refractory non-small cell lung cancer.

31 Mar 2010

PhRMA report: 234 medicines in development for special health care needs of children

America's pharmaceutical research and biotechnology companies are developing 234 medicines for the special health care needs of children, according to a new report released today by the Pharmaceutical Research and Manufacturers of America.

31 Mar 2010

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

PolyMedix, Inc., an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B clinical study with its novel defensin-mimetic antibiotic, PMX-30063. The data from the study demonstrate that administration of multiple doses of PMX-30063 are safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the study.

31 Mar 2010

NMS Labs launches test to evaluate the efficacy of Milnacipran

NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy, the potential for physicians to establish therapeutic drug monitoring of individual patients, and the assessment of drug diversion of a new pain management drug therapy.

31 Mar 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

Study indicates estrogenic drug could help treat schizophrenia

An estrogenic drug that influences neurotransmitter and neuronal systems in the brain is showing promise as an effective therapy for women who suffer from schizophrenia.

31 Mar 2010

Study evaluates OCP treatment to prevent endometrioma recurrence

Ovarian endometriomas, better known as ovarian 'chocolate' cysts for the brown liquid they contain, can be easily removed by surgery. However, recurrence is common, which can cause ongoing pain and complications. A study evaluated for Faculty of 1000 suggests a simple and effective remedy - the oral contraceptive pill.

31 Mar 2010

YM BioSciences receives approval to expand enrolment in Phase I/II clinical trial of CYT387

YM BioSciences Inc., announced that it has received ethics board approval to expand enrolment in its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis, a chronic debilitating condition, where patient's bone marrow is replaced by scar tissue.

31 Mar 2010

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced the initiation of a randomized, placebo and active controlled, multi-center Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This confirmatory Phase 3 study will be conducted at approximately 23 sites in the United States and randomize approximately 250 patients into three arms: Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).

31 Mar 2010

Efficacy News and Research

Data of focusing on Rebif and Cladribine Tablets to be presented at AAN Annual Meeting

Phase 1/2 human clinical trial of Symphogen's Sym004 initiated in the US

Major breakthrough may help develop low toxicity drugs for sleeping sickness

Repros Therapeutics announces response to FDA critique on proposed Phase II Androxal study

Positive results from Phase 2 clinical trial of OMS103HP

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Tanda Professional Restore light therapy now made available for at-home use

Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

ViroPharma initiates Phase 2 clinical study to evaluate Cinryze

SANUWAVE Health reports net loss of $2.7M for three months ended December 31, 2009

DSMB for DIGNITY trial recommends Celsion continue enrollment

ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

PhRMA report: 234 medicines in development for special health care needs of children

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

NMS Labs launches test to evaluate the efficacy of Milnacipran

Patients switching to Victoza experience further reductions in A1c and weight loss

Study indicates estrogenic drug could help treat schizophrenia

Study evaluates OCP treatment to prevent endometrioma recurrence

YM BioSciences receives approval to expand enrolment in Phase I/II clinical trial of CYT387

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

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Automating research - solutions and best practices

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