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Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

Ipsen today announced top line results of GuidAge®, the longest (5 years) and largest (2,854 subjects) European study in the prevention of Alzheimer's Dementia (AD). This trial was conducted according to the most stringent international standards. The aim of this study was to assess the efficacy of a 5-year treatment with EGb 761® in the prevention of Alzheimer's Dementia in a population of elderly aged 70 or more, with memory complaint spontaneously expressed to their family physician and who lived at home at the inclusion in the study.

22 Jun 2010

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

OrbusNeich today announced that six-month clinical follow-up data show the safety and efficacy of the combination of pre-dilatation with a paclitaxel drug-eluting balloon (Sequent Please®, B.Braun) followed by implantation of the company's Genous Bio-engineered R stent for the percutaneous treatment of coronary artery stenosis.

22 Jun 2010

NHLBI funds nine research grants to determine safety and efficacy of red blood cell transfusions

The National Heart, Lung, and Blood Institute, part of the National Institutes of Health, is funding nine research grants to determine if the safety and efficacy of red blood cell transfusions vary depending on how long the cells have been stored. One of the grants supports the first large, multi-center, randomized clinical trial to compare outcomes in heart surgery patients who receive transfusions of red blood cells that have been stored for shorter or longer amounts of time.

22 Jun 2010

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Forest Laboratories, Inc. and Merz Pharmaceuticals GmbH announced today that NAMENDA XR(TM) (memantine hydrochloride) was approved by the U.S. Food and Drug Administration for the treatment of moderate to severe dementia of the Alzheimer's type. NAMENDA XR is a 28 mg once-daily extended-release formulation of NAMENDA.

22 Jun 2010

Gastric bypass surgery improves insulin sensitivity in Type 2 diabetes patients

Gastric bypass surgery improves Type 2 diabetes by other mechanisms in addition to weight loss and does so better than a low-calorie diet despite achieving equal weight loss, a new study finds. The results will be presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

21 Jun 2010

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

Ferring Pharmaceuticals Inc. announced today the U.S. commercial availability of LYSTEDA™ (tranexamic acid) tablets, the only non-hormonal and non-surgical therapy indicated specifically for the treatment of women with cyclic heavy menstrual bleeding (HMB). In clinical studies, LYSTEDA significantly reduced menstrual blood loss (MBL) over three and six cycles of use with the reduction seen as early as the first cycle of use.

21 Jun 2010

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

Kowa Pharmaceuticals America, Inc., and Eli Lilly and Company today announced that LIVALO® (pitavastatin) tablets is now available in retail pharmacies throughout the United States. LIVALO, a statin medication approved by the U.S. Food and Drug Administration (FDA) in August 2009 is indicated for adults as an adjunctive therapy to diet for the treatment of primary hyperlipidemia or mixed dyslipidemia. LIVALO is available in doses of 1 mg, 2 mg and 4 mg.

21 Jun 2010

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

NanoViricides, Inc. reports that its anti-Dengue drug candidates demonstrated significant protection in the initial animal survival studies of Dengue virus infection. The studies were performed in the laboratory of Dr. Eva Harris, Professor of Infectious Diseases at the University of California, Berkeley.

21 Jun 2010

Ostarine increases muscle mass and strength in postmenopausal women: Study

GTx, Inc. announced that Ostarine (GTx-024, formerly MK-2866) increased lean body mass and leg press strength in a head to head study evaluating Ostarine and another selective androgen receptor modulator, MK-3984, in postmenopausal women. The data were presented yesterday at the 2010 Annual Meeting of the Endocrine Society. GTx is developing its lead SARM, Ostarine, for the treatment of cancer induced muscle wasting (cancer cachexia).

21 Jun 2010

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Affymax, Inc. and Takeda Global Research & Development Center, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, today announced preliminary top-line results from the Phase 3 clinical program for the investigational drug, Hematide™/peginesatide, for the treatment of anemia in chronic renal failure patients.

21 Jun 2010

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Stallergenes S.A. announces the results of a phase III clinical trial (VO55.06) conducted in China aimed at assessing the efficacy and safety of sublingual immunotherapy (Staloral(R) mites 300) in adult patients suffering from asthma triggered by house dust mites.

21 Jun 2010

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

The Reproductive Health Drugs Advisory Committee met today to discuss the new drug application (NDA) for flibanserin 100 mg as a treatment for Hypoactive Sexual Desire Disorder (HSDD) in pre-menopausal women. The advisory committee was convened by and makes recommendations to the U.S. Food and Drug Administration (FDA). The FDA will consider the committee's advice as part of its final assessment of the NDA.

19 Jun 2010

Advisory panel recommends FDA approve new "morning after" pill

The New York Times: A Food and Drug Administration advisory panel Thursday recommended that the agency approve "a medicine that could help prevent pregnancy if taken as late as five days after unprotected sex. The pill, called ella, sprang from government labs and appears to be more effective than Plan B, a morning-after pill now available over the counter to women 18 and older that gradually loses efficacy after intercourse and can be taken at latest three days after sex.

18 Jun 2010

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

The first data to show that Neupro® (rotigotine transdermal system) significantly improved wellbeing and daily activities that are often impaired by pain related to Restless Legs Syndrome (RLS) were presented this week at the 14th International Congress of Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.

18 Jun 2010

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Ardea Biosciences, Inc. announced that additional positive data from its Phase 2 program for RDEA594, its lead product candidate for the treatment of hyperuricemia and gout, are being presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism (EULAR) in Rome, Italy. RDEA594, a first-in-class selective inhibitor of the URAT1 transporter, treats the underlying cause of gout by increasing the excretion of uric acid in order to bring the body's levels of uric acid into a normal range.

18 Jun 2010

Children's Hospital Boston receives $2.4M Gates Foundation grant to develop novel neonatal vaccines

Children's Hospital Boston announced today that it has received a $2.4 million grant from the Bill & Melinda Gates Foundation. The grant will support the development of novel vaccines for newborns – research that is spearheaded by Ofer Levy, MD, Ph.D., a principal investigator in the Division of Infectious Diseases at Children's.

18 Jun 2010

St. Jude Medical's Therapy Cool Flex Ablation Catheter granted European CE Mark approval

St. Jude Medical, Inc., a global medical device company, today announced European CE Mark approval of the Therapy™ Cool Flex™ Ablation Catheter at the 17th World Congress in Cardiac Electrophysiology and Cardiac Techniques (CardioStim). The ablation catheter is the industry's first to have a fully-irrigated and flexible tip, which can potentially improve the safety and efficacy of cardiac ablation procedures.

18 Jun 2010

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Inspire Pharmaceuticals, Inc. announced today that data is being presented on denufosol tetrasodium, an investigational therapy for cystic fibrosis (CF), during an oral presentation and poster presentations at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference June 16 - 19, 2010 in Valencia, Spain.

18 Jun 2010

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Human Genome Sciences, Inc. and GlaxoSmithKline PLC today announced the presentation of additional results from BLISS-52, one of two pivotal Phase 3 trials of BENLYSTA (belimumab) in seropositive patients with systemic lupus erythematosus. The additional data will be presented in Rome at the 2010 Congress of the European League against Rheumatism on Saturday, June 19.

18 Jun 2010

Agilent launches 1260 Infinity bio-inert quaternary liquid chromatography system

Agilent Technologies Inc. today introduced the 1260 Infinity bio-inert quaternary liquid chromatography (LC) system designed to characterize and confirm large biomolecules, especially new biological entities (NBEs) and therapeutic monoclonal antibodies.

18 Jun 2010

Efficacy News and Research

Ipsen reports top line results from European study of GuidAge for Alzheimer's Dementia

OrbusNeich's Genous Bio-engineered R stent shows safety for percutaneous treatment of coronary artery stenosis

NHLBI funds nine research grants to determine safety and efficacy of red blood cell transfusions

FDA approves NAMENDA XR for treatment of Alzheimer's type dementia

Gastric bypass surgery improves insulin sensitivity in Type 2 diabetes patients

Ferring announces availability of LYSTEDA for cyclic heavy menstrual bleeding in U.S.

LIVALO for primary hyperlipidemia or mixed dyslipidemia now available in U.S.

NanoViricides' anti-Dengue drug candidates demonstrate potential against severe virus infection

Ostarine increases muscle mass and strength in postmenopausal women: Study

Preliminary top-line results from Hematide Phase 3 program for anemia in chronic renal failure patients

Staloral 300 demonstrates efficacy in phase III study for control of asthma in China

Boehringer Ingelheim disappointed with FDA Advisory Committee recommendations on flibanserin NDA for HSDD

Advisory panel recommends FDA approve new "morning after" pill

Neupro improves wellbeing impaired by pain related to Restless Legs Syndrome

Additional positive data from Ardea Biosciences' RDEA594 Phase 2 program presented at EULAR

Children's Hospital Boston receives $2.4M Gates Foundation grant to develop novel neonatal vaccines

St. Jude Medical's Therapy Cool Flex Ablation Catheter granted European CE Mark approval

Inspire's TIGER-1 Phase 3 clinical trial data with denufosol for CF presented at 33rd ECFS

Additional results from BLISS-52 Phase 3 trial of BENLYSTA for SLE to be presented at EULAR 2010

Agilent launches 1260 Infinity bio-inert quaternary liquid chromatography system

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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