Efficacy News and Research

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Australians discover treatment for very common female infection

Starpharma Holdings Limited has announced successful results of a major phase 2 clinical study that demonstrated efficacy of VivaGel® for the treatment of bacterial vaginosis (BV).

22 May 2011

NIH allocated $400 million funding for pain research in 2010

An unprecedented level of federal funding for pain research, some $400 million, was allocated in 2010 by the National Institutes of Health (NIH) through provisions of the American Recovery and Investment Act and the Affordable Care Act to help accelerate advances in pain research, prevention and treatment.

21 May 2011

Stimulating electrode array assists paralyzed man to regain voluntary movements of limbs

A team of researchers from the University of California, Los Angeles (UCLA), the California Institute of Technology (Caltech), and the University of Louisville have used a stimulating electrode array to assist a paralyzed man to stand, step on a treadmill with assistance, and, over time, to regain voluntary movements of his limbs.

21 May 2011

Global clinical program demonstrates safety of Medtronic Resolute drug-eluting stent

A pooled analysis of the global RESOLUTE clinical program presented today during a late-breaking clinical trials session at EuroPCR demonstrated the strong safety record of the Resolute drug-eluting stent (DES) from Medtronic, Inc., across a wide variety of patient and lesion types.

From Medtronic 21 May 2011

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Salix Pharmaceuticals, Ltd. today announced findings from two analyses of a Phase 3 open-label study of RELISTOR (methylnaltrexone bromide) presented at the 30th Annual Scientific Meeting of the American Pain Society. The meeting is being held in Austin, TX, on May 19-21, 2011.

21 May 2011

Bristol-Myers Squibb to present abstracts on oncology compounds at ASCO 2011 Annual Meeting

Bristol-Myers Squibb Company, a leading global BioPharma company in oncology, today announced that more than 95 scientific abstracts on its approved and investigational oncology compounds will be featured at the 47th Annual Meeting of the American Society of Clinical Oncology in Chicago from June 3-7.

21 May 2011

Researchers to examine different teaching models for children with ASD

Researchers from the University of Miami Department of Psychology participated in a multi-site study to examine different teaching models for children with Autism Spectrum Disorder. The study is one of the first to look at the fidelity of treatment models for preschoolers with autism.

21 May 2011

Cordis EXOSEAL Vascular Closure Device receives approval in the U.S.

Cordis Corporation, a worldwide leader in the development and manufacture of interventional vascular technology, today announced the approval of the EXOSEAL Vascular Closure Device in the US. EXOSEAL incorporates a number of new advances in technology and simplicity of design to provide precise and secure extravascular arterial closure.

21 May 2011

Pediatric pain experts discuss safety, efficacy of pain medications in children

Can we be certain that pain medications considered safe for adults, based on extensive clinical data and experience, are equally safe for use in young children? Pediatric pain experts discussed this question today in a panel session at the American Pain Society, www.ampainsoc.org, annual scientific meeting and agreed more short term and long-term clinical data are needed to provide assurances about the safety and efficacy of several pain medications in children.

21 May 2011

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

Efficacy News and Research

Australians discover treatment for very common female infection

NIH allocated $400 million funding for pain research in 2010

Stimulating electrode array assists paralyzed man to regain voluntary movements of limbs

Global clinical program demonstrates safety of Medtronic Resolute drug-eluting stent

Phase 3 open-label study of RELISTOR presented at American Pain Society meeting

Bristol-Myers Squibb to present abstracts on oncology compounds at ASCO 2011 Annual Meeting

Researchers to examine different teaching models for children with ASD

Cordis EXOSEAL Vascular Closure Device receives approval in the U.S.

Pediatric pain experts discuss safety, efficacy of pain medications in children

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

Achieving and maintaining ISO/IEC 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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