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Inorganic nitrate reduces rate of heart dysfunction caused by doxorubicin

Virginia Commonwealth University researchers have found that nutrient supplementation, like the kind that is found in leafy greens, spinach and lettuce, may reduce the damage to the heart caused by a powerful anti-cancer drug.

20 May 2011

EMA CHMP recommends conditional marketing authorization of FAMPYRA

The Committee for Medicinal Products for Human Use of the European Medicine Agency has recommended conditional marketing authorization of FAMPYRA (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability.

20 May 2011

HSS researchers develop new tool to compare efficacy of different brachial plexus surgical treatments

The way that clinicians report outcomes of surgery for a traumatic nerve injury involving the arm is not standardized, and it is thus difficult to compare the efficacy of different surgical treatments, according to a study by researchers at Hospital for Special Surgery (HSS) in New York.

20 May 2011

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended a positive opinion for the marketing authorization of XGEVA (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.

20 May 2011

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Merck, today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion under accelerated assessment recommending approval of the investigational medicine VICTRELIS (boceprevir) for the treatment of chronic hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin, in adult patients with compensated liver disease who are previously untreated or who have failed previous therapy.

20 May 2011

Indian wild plants offer hope against resistant infections

Cancer treatments often have the side effect of impairing the patient's immune system. This can result in life-threatening secondary infections from bacteria and fungi, especially since bacteria, like Staphylococcus aureus, are becoming multi-drug resistant.

20 May 2011

EMA CHMP issues positive opinion for marketing approval of BENLYSTA

GlaxoSmithKline and Human Genome Sciences, Inc. announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion, recommending marketing authorisation for BENLYSTA (belimumab) as an add-on therapy in adult patients with active autoantibody-positive systemic lupus erythematosus, with a high degree of disease activity, despite standard therapy.

20 May 2011

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced results from the ASPIRE phase 2b study that evaluates the addition of once daily TMC435 to pegylated interferon and ribavirin in patients with genotype 1 chronic hepatitis C whose prior treatment with pegylated-interferon (PegIFN) and ribavirin (RBV) was unsuccessful either because they relapsed, had a partial response or had a null response.

20 May 2011

RTOG reports on largest trial for newly diagnosed glioblastoma

RTOG reports on the largest trial to-date for patients with newly diagnosed glioblastoma demonstrating the importance and feasibility of prospective molecular analysis of tumor tissue although finding that patients received no additional benefit from dose-intensive temozolomide as compared to standard adjuvant temozolomide after combined temozolomide and radiotherapy.

20 May 2011

AMT presents long-term efficacy study of Glybera in treatment of lipoprotein lipase deficiency

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today results from a long-term efficacy study of Glybera (alipogene tiparvovec) that showed improved chylomicron metabolism could be used as a biomarker for increased lipoprotein lipase (LPL) activity in those patients missing the gene that produces this protein.

20 May 2011

Complementary and alternative health practices show promise for management of pain

A variety of complementary and alternative health practices —including meditation and relaxation techniques, manual therapies such as massage and spinal manipulation, meditative exercise forms such as yoga, Tai Chi, and ancient health practices such as acupuncture—show promise for contributing to the management of pain according to research presented at the Annual Scientific Meeting of the American Pain Society, www.ampainsoc.org.

20 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Advantagene, Inc., a Massachusetts-based biopharmaceutical company, announced today that it reached an agreement with the U.S. Food and Drug Administration on a Special Protocol Assessment (SPA) for a pivotal Phase 3 clinical trial of ProstAtak™, its lead agent for patients with newly diagnosed prostate cancer.

19 May 2011

Positive six-month results from BIOSOLVE-I FIM trial of DRug-Eluting Absorbable Metal Scaffold device

Six-month results from the BIOSOLVE-I first-in-man (FIM) trial, studying the DRug-Eluting Absorbable Metal Scaffold (DREAMS), demonstrate a high safety profile of the novel device.

19 May 2011

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted and immunotherapy technologies, will be presenting data from the NeuVax Phase II adjuvant breast cancer clinical trial at the 2011 annual meeting of The American Society of Clinical Oncology in Chicago.

19 May 2011

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

Omeros Corporation today announced that it is advancing two of its product candidates from its PharmacoSurgery platform – OMS103HP for arthroscopic meniscectomy and OMS302 for intra-ocular lens replacement surgery – into Phase 3 clinical development programs.

19 May 2011

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

TissueGene, Inc. announced today that it has initiated patient enrollment for a U.S. Phase II clinical trial of its lead product candidate TG-C. TG-C involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 for the regeneration of cartilage in patients suffering from severe osteoarthritis of the knee.

19 May 2011

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

YM BioSciences Inc., today reported updated interim results for the first 60 patients with high/intermediate-risk myelofibrosis who have completed a minimum of three cycles of treatment (12 weeks) in its ongoing Phase I/II multi-center study.

19 May 2011

Alemtuzumab as effective as other more expensive immune suppressants for kidney transplants

In the first head-to-head comparison of the three most common drugs used at the time of a kidney transplant to prevent organ rejection, researchers found that the least expensive drug - at one-half to one-fifth the price - is as safe and effective as the other two, according to a paper published by University of Alabama at Birmingham researchers in the May 19, 2011, issue of the New England Journal of Medicine.

19 May 2011

Face masks worn by TB patients could cut transmission rates to non-infected patients

Face masks worn by patients infected with tuberculosis (TB) may be able to significantly cut transmission rates to non-infected patients, according to a new study by researchers from the U.S. and South Africa. The study was conducted in a specialized airborne infections research facility in South Africa, which was designed to allow study of methods to control the spread of TB.

18 May 2011

Efficacy News and Research

Inorganic nitrate reduces rate of heart dysfunction caused by doxorubicin

EMA CHMP recommends conditional marketing authorization of FAMPYRA

HSS researchers develop new tool to compare efficacy of different brachial plexus surgical treatments

EMA CHMP recommends positive opinion for marketing authorization of Amgen's XGEVA

Merck's VICTRELIS receives European CHMP positive opinion for treatment of chronic HCV genotype 1 infection

Indian wild plants offer hope against resistant infections

EMA CHMP issues positive opinion for marketing approval of BENLYSTA

Medivir reports positive results from ASPIRE TMC435 phase 2b study for genotype 1 chronic hepatitis C

RTOG reports on largest trial for newly diagnosed glioblastoma

AMT presents long-term efficacy study of Glybera in treatment of lipoprotein lipase deficiency

Complementary and alternative health practices show promise for management of pain

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

Advantagene reaches SPA agreement with FDA for ProstAtak Phase 3 trial to prevent prostate cancer recurrence

Positive six-month results from BIOSOLVE-I FIM trial of DRug-Eluting Absorbable Metal Scaffold device

RXi to present updated NeuVax Phase II trial data in breast cancer at ASCO 2011

Omeros advances OMS103HP and OMS302 into Phase 3 clinical programs

TissueGene commences enrollment in TG-C Phase II trial for severe knee osteoarthritis

YM BioSciences announces updated interim results from CYT387 Phase I/II trial in myelofibrosis

Alemtuzumab as effective as other more expensive immune suppressants for kidney transplants

Face masks worn by TB patients could cut transmission rates to non-infected patients

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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