Therapy News and Research

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PTC announces ataluren Phase 2b efficacy data at International Congress

PTC Therapeutics, Inc. today announced that final analyses of Phase 2b efficacy data suggest the investigational new drug ataluren slowed the loss of walking ability in patients with nonsense mutation dystrophinopathy, a disease continuum comprising Duchenne and Becker muscular dystrophy (nmDBMD). These data were presented at the International Congress of the World Muscle Society in Kumamoto, Japan and will be the basis of interactions with the U.S. Food and Drug Administration (FDA) and national regulatory authorities in Europe in the fourth quarter of 2010.

18 Oct 2010

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

Novartis announced today that new six-year data reinforce the long-term efficacy and safety profile of once-yearly Reclast (zoledronic acid) injection in postmenopausal women with osteoporosis. The study of more than 1,200 women was presented this weekend at the annual meeting of the American Society for Bone and Mineral Research (ASBMR) in Toronto, ON, Canada.

18 Oct 2010

2010 AAO-MEACO meeting focuses on genetic medicine

Genetic medicine is the focus of two presentations at today's Scientific Program of the 2010 American Academy of Ophthalmology (AAO) Middle East-Africa Council of Ophthalmology (MEACO) Joint Meeting. The AAO-MEACO meeting is in session October 16 through 19 at McCormick Place, Chicago. It is the largest, most comprehensive ophthalmic education conference in the world.

18 Oct 2010

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Questcor Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Questcor's supplemental new drug application (sNDA) for H.P. Acthar® Gel (repository corticotropin injection) in the treatment of infantile spasms (IS), an ultra-rare orphan disorder affecting approximately 2,000 American children annually. IS is a devastating and potentially life-threatening form of epilepsy seen in infancy and early childhood.

15 Oct 2010

Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

Medtronic, Inc. today announced U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating the Medtronic CoreValve System for transcatheter aortic valve implantation (TAVI).

15 Oct 2010

CVS Caremark to present client experiences on innovative approaches at AMCP Conference

CVS Caremark is presenting data at the Academy of Managed Care Pharmacy (AMCP) 2010 Educational Conference illustrating how innovative approaches to traditional plan designs can help clients reduce drug spend, improve generic dispensing rates (GDR) and minimize member disruption.

15 Oct 2010

GI Dynamics' EndoBarrier therapy to treat type 2 diabetes and obesity granted European CE mark approval

GI Dynamics, a leader in non-surgical, endoscopic treatments for type 2 diabetes and obesity, today announced that it has received European CE mark approval for the EndoBarrier, a non-surgical therapy to treat type 2 diabetes and obesity. This approval is specific to up to 12 months of treatment with the EndoBarrier; the product has already received CE mark approval for three and six months of treatment. Through its commercial partner, Elemental Healthcare, GI Dynamics has also announced the launch of the EndoBarrier in the United Kingdom.

15 Oct 2010

Emerging Healthcare anticipates results of FDA-approved human embryonic stem-cell treatment

Emerging Healthcare Solutions, Inc. eagerly anticipates the results of the first FDA-approved human embryonic stem-cell treatment on a patient with spinal cord injuries, which began this week.

15 Oct 2010

A new therapeutic approach for cancer

Trials are being organized for a new therapeutic approach to treating cancer, under exclusive license by Viral Genetics, Inc. According to Scott & White Healthcare Senior Vice President for Research Richard E. Beswick, M.D., who is also assistant dean of research at the Texas A&M Health Science Center College of Medicine, the trials will be conducted at the Glenda Tanner Vasicek Cancer Treatment Center, located at Scott & White in Temple, Texas.

15 Oct 2010

Startech, STRCIC invest $2.5 million in ViroXis Corporation

Startech and the South Texas Regional Center of Innovation and Commercialization (STRCIC) today announced the investment of $2.5 million in San Antonio-based ViroXis Corporation by the Texas Emerging Technology Fund (TETF).

15 Oct 2010

GfK HealthCare: RRMS patients anticipate availability of new oral therapies

Relapsing-Remitting Multiple Sclerosis (RRMS) patients have been anticipating the availability of new oral therapies being developed to treat their specific condition. Among the string of oral therapies entering the market is Novartis' Gilenya, which recently became available for use following receipt of FDA approval in late September. One-third of MS patients are aware the new oral agents are under development and there is substantial interest within this group to seek further information through physicians and other sources, according to new research by GfK HealthCare.

15 Oct 2010

Experts use multi-disciplinary approach to provide innovative care for children

Liver tumors affect more than 300 children in the United States each year and management of these children requires coordinated comprehensive care from experts in many disciplines. To answer this problem, Texas Children's Hospital and Baylor College of Medicine announced today the formation of a new Liver Tumor Center that brings together renowned specialists in all aspects of liver cancer who will utilize a multi-disciplinary approach to provide the most comprehensive and innovative care for children afflicted with these diseases.

15 Oct 2010

Study: Characteristics of children with OCD could help predict personalized medicine approach

New research from the Bradley Hasbro Children's Research Center may help clinicians better predict how a child with obsessive compulsive disorder (OCD) will respond to some of the most commonly used treatment approaches. The findings, published in the October issue of the Journal of the American Academy of Child and Adolescent Psychiatry, could help guide important clinical decisions about the best intervention for children with this often debilitating anxiety disorder.

15 Oct 2010

Proper dosing of beta blockers can save many lives after heart attack

For nearly 40 years a class of drugs known as beta blockers have been proven to increase patients' survival prospects following a heart attack by decreasing the cardiac workload and oxygen demand on the heart. In a breakthrough study released in the American Heart Journal, Northwestern Medicine cardiologist Jeffrey J. Goldberger found the majority of patients are frequently not receiving a large enough dose of these drugs, which can put their recovery from heart attacks and overall health into peril.

15 Oct 2010

Sanofi-aventis announces TEMSO phase III study results for relapsing multiple sclerosis

Sanofi-aventis announced today the results from the two year phase III TEMSO study of teriflunomide, a novel oral disease modifier investigated for the treatment of relapsing multiple sclerosis (RMS).

15 Oct 2010

Octapharma USA accepts applications for 25th Anniversary Grants Program

Octapharma USA is accepting applications for the Octapharma 25th Anniversary Grants Program, which supports clinical or pre-clinical research focused on human protein therapies in coagulation disorders, immune therapy, intensive care and emergency medicine. The application deadline is April 1, 2011.

15 Oct 2010

Administering ondansetron drug to children is economically advantageous

Two years ago, a study by University of North Carolina at Chapel Hill researchers found that an anti-vomiting drug called ondansetron helps reduce vomiting, the need for intravenous fluids and hospital admissions in children with acute gastroenteritis.Now a new economic analysis led by Canadian researchers, in collaboration with Michael J. Steiner, MD, assistant professor of pediatrics at UNC, concludes that routinely giving ondansetron to children with gastroenteritis-induced vomiting would prevent thousands of hospitalizations and save millions of dollars each year.

15 Oct 2010

FibroGen announces initiation of FG-3019 phase 2 study for reversing liver fibrosis

FibroGen, Inc. today announced initiation of a phase 2 study to compare the efficacy of FG-3019, a human monoclonal antibody against connective tissue growth factor (CTGF), with placebo in reversing liver fibrosis (scarring of the liver) due to chronic infection with hepatitis B virus (HBV).

15 Oct 2010

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

Genzyme Corporation today reported five-year patient data from its completed Phase 2 multiple sclerosis (MS) trial. This sub-group analysis found that nearly 90 percent of alemtuzumab-treated patients were free of sustained accumulation of disability, and that patients receiving alemtuzumab also maintained improved mean disability scores and a low risk of relapse over the 60-month follow-up period.

15 Oct 2010

BIOTRONIK announces European release of TI Trend Chart

BIOTRONIK SE Co. & KG, leading manufacturer of cardiovascular devices, has announced the European release of its Thoracic Impedance (TI) Trend Chart via its pioneering BIOTRONIK Home Monitoring technology and Lumax 540 implantable cardiac defibrillator (ICD) series.

15 Oct 2010

Therapy News and Research

PTC announces ataluren Phase 2b efficacy data at International Congress

Six-year data of reinforces efficacy and safety of Reclast injection in postmenopausal women with osteoporosis

2010 AAO-MEACO meeting focuses on genetic medicine

Questcor's H.P. Acthar Gel sNDA for infantile spasms receives FDA approval

Medtronic CoreValve System IDE for transcatheter aortic valve implantation receives FDA approval

CVS Caremark to present client experiences on innovative approaches at AMCP Conference

GI Dynamics' EndoBarrier therapy to treat type 2 diabetes and obesity granted European CE mark approval

Emerging Healthcare anticipates results of FDA-approved human embryonic stem-cell treatment

A new therapeutic approach for cancer

Startech, STRCIC invest $2.5 million in ViroXis Corporation

GfK HealthCare: RRMS patients anticipate availability of new oral therapies

Experts use multi-disciplinary approach to provide innovative care for children

Study: Characteristics of children with OCD could help predict personalized medicine approach

Proper dosing of beta blockers can save many lives after heart attack

Sanofi-aventis announces TEMSO phase III study results for relapsing multiple sclerosis

Octapharma USA accepts applications for 25th Anniversary Grants Program

Administering ondansetron drug to children is economically advantageous

FibroGen announces initiation of FG-3019 phase 2 study for reversing liver fibrosis

Genzyme reports five-year patient data from Phase 2 multiple sclerosis trial

BIOTRONIK announces European release of TI Trend Chart

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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