Efficacy News and Research

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Diabetic individuals living in hot climate need increased 'heat awareness'

A new survey shows that diabetic individuals who live in a hot climate have important gaps in their "heat awareness," or knowledge about proper diabetes self-care in hot weather, even though diabetes raises their risk of heat illness. The results of "Diabetes in the Desert: What Do Patients Know About the Heat?" will be presented Monday at The Endocrine Society's 92nd Annual Meeting in San Diego.

22 Jun 2010

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Inovio Pharmaceuticals, Inc., a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that the peer-reviewed journal Molecular Therapy has published a paper entitled "Comparative Analysis of Immune Responses Induced by Vaccination With SIV Antigens by Recombinant Ad5 Vector or Plasmid DNA in Rhesus Macaques." The paper, co-authored by researchers from Merck, University of Pennsylvania School of Medicine, and Inovio Pharmaceuticals, notes that significant advances in the design, formulation, and delivery of DNA plasmid-based vaccines have dramatically increased their ability to induce antigen-specific immune responses.

22 Jun 2010

Omega-3 effective for treating depression in patients without anxiety disorders

The use of Omega-3 supplements is effective among patients with major depression who do not have anxiety disorders, according to a study directed by Dr. Fran-ois Lesp-rance of the Centre de recherche du Centre hospitalier at the Universit- de Montr-al (CRCHUM), head of CHUM's Department of Psychiatry and a professor at the Universit- de Montr-al. The study was published June 15 in the online Journal of Clinical Psychiatry.

22 Jun 2010

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

BioSante Pharmaceuticals, Inc. commented today that the recommendation on June 18, 2010 by the FDA Advisory Committee regarding the safety and efficacy of flibanserin (Boehringer-Ingelheim) will have no impact on its own ongoing development program or approval pathway for LibiGel (testosterone gel), for the treatment of hypoactive sexual desire disorder (HSDD).

22 Jun 2010

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company's topical formulation achieved target retina/choroid concentrations with minimal systemic exposure.

22 Jun 2010

Lack of tracking of medical devices' performance raises questions about safety and efficacy

"Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices.

22 Jun 2010

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

Efficacy News and Research

Diabetic individuals living in hot climate need increased 'heat awareness'

SynCon DNA vaccine shows advantages in magnitude and breadth of immune responses in non-human primates

Omega-3 effective for treating depression in patients without anxiety disorders

FDA Advisory Committee recommendation against flibanserin will not affect LibiGel program: BioSante

OXiGENE reports encouraging data from ZYBRESTAT program at Glaucoma and Retinopathies 2010 conference

Lack of tracking of medical devices' performance raises questions about safety and efficacy

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

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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