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Warning of serious side-effects of quit-smoking drug Champix

Australian doctors have been warned about the the quit-smoking drug Champix, according to the Therapeutic Goods Administration (TGA) care must be taken when prescribing Champix (varenicline), because of possible serious side-effects.

2 Dec 2008

ViroPharma Inc. submits sBLA for Cinryze to treat acute attacks of hereditary angioedema

ViroPharma Inc. has announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE).

1 Dec 2008

Cardiac CT effectively assesses coronary artery stenosis

Cardiac CT can effectively assess coronary artery stenosis, according to a large study performed at Leiden University Medical Center in Leiden, The Netherlands.

1 Dec 2008

Genaera starts trial of Trodusquemine in overweight and obese type 2 diabetes

Genaera Corporation has announced that dosing of subjects has begun in study MSI-1436C-102 (Study 102), the multiple ascending dose Phase 1b study of trodusquemine (MSI-1436) in overweight and obese type 2 diabetics.

1 Dec 2008

Alcohol-dependence study looks at impact of pharmacotherapy on quality-of-life

Most studies examining the impact of alcohol-dependence (AD) treatment on quality-of-life (QOL) have looked at psychosocial treatments.

1 Dec 2008

Anadys Pharmaceuticals receives fast track for ANA598 treatment of chronic hepatitis C virus

Anadys Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to ANA598 for the treatment of chronic hepatitis C virus (HCV) infection. ANA598 is Anadys' investigational hepatitis C non-nucleoside polymerase inhibitor.

1 Dec 2008

Eli Lilly withdraws application for additional U.S. indication for Cymbalta for chronic pain

Eli Lilly and Company has withdrawn its supplemental New Drug Application (sNDA) from the U.S. Food and Drug Administration (FDA) for Cymbalta (duloxetine HCl) for the management of chronic pain.

30 Nov 2008

Breakthrough for dialysis patients

Suffering from end-stage renal disease (ESRD), a growing number of patients at the Centre hospitalier de l'Université de Montréal (CHUM), have become the beneficiaries of a North American breakthrough: high efficacy hemodiafiltration (HDF).

28 Nov 2008

EpiVax receives grant for $390,000 to optimize HIV vaccine delivery

EpiVax, Inc., a leader in the field of computational immunology, announced today that it has received a grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to optimize delivery of an HIV vaccine.

26 Nov 2008

Ceregene announces data from phase 2 clinical trial of CERE-120 for Parkinson's

Ceregene, Inc., a biopharmaceutical company, today reported clinical data from a double-blind, controlled Phase 2 trial of CERE-120 in 58 patients with advanced Parkinson's disease.

26 Nov 2008

Study looks at amount of time single mothers are able to give their children

"Time poor" single mothers come surprisingly close in the number of hours they spend caring for their children compared to married mothers, and the difference is explained almost entirely by socio-economic factors and the kind of jobs they hold, say University of Maryland sociologists in a new study.

25 Nov 2008

Selzentry (maraviroc) becomes fully approved HIV antiretrovial

The U.S. Food and Drug Administration (FDA) has granted Selzentry (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals.

25 Nov 2008

AIDS advocates tell WHO: Stop harmful single-dose treatment for expectant mothers and infants

As World AIDS Day 2008 approaches, a coalition of hundreds of HIV/AIDS medical care providers and advocates, representing dozens of organizations, today sent a letter to Dr. Margaret Chan, Director General of the World Health Organization (WHO), urging an end to harmful single-dose HIV/AIDS treatment as a recommended treatment for expectant mothers and infants worldwide.

25 Nov 2008

Novel device enhances efficacy of standard chemotherapy

NovoCure Ltd. presented results yesterday evaluating the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients.

24 Nov 2008

Ustekinumab receives positive opinion in Europe for treatment of plaque psoriasis

Janssen-Cilag announced today that ustekinumab, the first in a new class of biologics, has received a positive opinion for the treatment of moderate to severe plaque psoriasis from the European Committee for Medical Products for Human Use (CHMP).

24 Nov 2008

FDA accepts Labopharm's NDA for formulation of trazodone

Labopharm Inc. has announced that its New Drug Application (NDA) for the Company's novel once-daily formulation of trazodone (DDS-04A), a serotonin antagonist reuptake inhibitor (SARI), for the treatment of major depressive disorder, has been accepted for review and filed by the U.S. Food and Drug Administration (FDA).

24 Nov 2008

Valdoxan - a melatonergic antidepressant - receives positive European opinion for major depressive disorder

The first melatonergic antidepressant - Valdoxan/Thymanax (agomelatine) - has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD).

21 Nov 2008

Long-term use of a macrolide antibiotic reduce COPD exacerbations, raise questions

Long-term use of a macrolide antibiotic may reduce the frequency of exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD) by as much as 35 percent, according to a London-based study.

21 Nov 2008

Epeius Biotechnologies announces results of Rexin-G in chem-resistant metastatic soft tissue sarcoma and osteosarcoma

Epeius Biotechnologies announced today the results of Phase I/II and II studies of Rexin-G in chemotherapy-resistant metastatic soft tissue sarcoma and osteosarcoma, as presented by Dr. Sant P. Chawla, principal investigator, at the CTOS 14th annual meetings held in London UK on November 13-15, 2008.

20 Nov 2008

Bionovo to present phase 1B trial results of BZL101 in metastatic breast cancer

Bionovo, Inc. has announced the company will present results from the Phase 1B clinical trial of their lead drug candidate for advanced metastatic breast cancer, BZL101, at the Society for Integrative Oncology's Fifth International Conference in Atlanta, Georgia.

20 Nov 2008

Efficacy News and Research

Warning of serious side-effects of quit-smoking drug Champix

ViroPharma Inc. submits sBLA for Cinryze to treat acute attacks of hereditary angioedema

Cardiac CT effectively assesses coronary artery stenosis

Genaera starts trial of Trodusquemine in overweight and obese type 2 diabetes

Alcohol-dependence study looks at impact of pharmacotherapy on quality-of-life

Anadys Pharmaceuticals receives fast track for ANA598 treatment of chronic hepatitis C virus

Eli Lilly withdraws application for additional U.S. indication for Cymbalta for chronic pain

Breakthrough for dialysis patients

EpiVax receives grant for $390,000 to optimize HIV vaccine delivery

Ceregene announces data from phase 2 clinical trial of CERE-120 for Parkinson's

Study looks at amount of time single mothers are able to give their children

Selzentry (maraviroc) becomes fully approved HIV antiretrovial

AIDS advocates tell WHO: Stop harmful single-dose treatment for expectant mothers and infants

Novel device enhances efficacy of standard chemotherapy

Ustekinumab receives positive opinion in Europe for treatment of plaque psoriasis

FDA accepts Labopharm's NDA for formulation of trazodone

Valdoxan - a melatonergic antidepressant - receives positive European opinion for major depressive disorder

Long-term use of a macrolide antibiotic reduce COPD exacerbations, raise questions

Epeius Biotechnologies announces results of Rexin-G in chem-resistant metastatic soft tissue sarcoma and osteosarcoma

Bionovo to present phase 1B trial results of BZL101 in metastatic breast cancer

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