Pediatric in Medical Technology

Keryx Biopharmaceuticals, Inc. Commences Phase 1 Study of KRX-0401 (Perifosine) in Recurrent Pediatric Solid Tumors at Memorial Sloan-Kettering Cancer Center

NEW YORK, July 14 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ) announced today the initiation of a Phase 1 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for recurrent solid tumors in pediatric patients. This Phase 1 study is now ope...

Sanofi Pasteur Dengue Vaccine Enters Pediatric Efficacy Clinical Study

LYON, France, February 18 /PRNewswire-FirstCall/ -- - Global Clinical Study Program Across Dengue Endemic Regions in Latin America and Asia Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT : SAN and NYSE : SNY), announced today that its investigational tetr...

Meritage Pharma Initiates Phase 2b Clinical Trial of Oral Viscous Budesonide for Pediatric Patients With Eosinophilic Esophagitis

SAN DIEGO, Jan. 22 /PRNewswire/ -- Meritage Pharma, Inc. announced today that it has initiated a dose-ranging Phase 2b clinical trial to evaluate oral viscous budesonide (OVB) for the treatment of children and adolescents with eosinophilic esophagitis (EoE), an allergic inflammatory condition of t...

STALLERGENES: Oralair(R) Grasses Obtains a Pediatric MA(1) in Germany

ANTONY, France, January 19 /PRNewswire-FirstCall/ -- Stallergenes S.A. today announced that the Paul Ehrlich Institute, the German agency in charge of regulating biological products, has approved its application for a pediatric extension (5-17 years) of the indications for Oralair(R) Grasses, ...

Colesevelam HCl Lowered LDL Cholesterol in Pediatric Patients With Heterozygous Familial Hypercholesterolemia

First Presentation of Pivotal Study Data in Pediatric Patients Presented at the American Heart Association's Annual Scientific Sessions 2008 PARSIPPANY, N.J., Nov. 11 /PRNewswire-FirstCall/ -- Daiichi Sankyo, Inc. (DSI), announced today that results from the pivotal study supporting the use ...

MedImmune Advances Pediatric Disease Prevention Program With Start of Phase 1/2a Clinical Trial for Respiratory Syncytial Virus Vaccine

GAITHERSBURG, Md., Nov. 3 /PRNewswire/ -- MedImmune today announced that it has initiated a Phase 1/2a clinical trial of a live, attenuated intranasal vaccine in healthy children one month to 12 months of age to help prevent severe respiratory syncytial virus (RSV) infections. RSV is the most ...

Berlin Heart's EXCOR(R) Pediatric Receives Unconditional Investigational Device Exemption (IDE) Approval

BERLIN, October 16 /PRNewswire/ -- Berlin Heart Inc. today announced its EXCOR(R) Pediatric ventricular assist device (VAD) has received unconditional approval for the ongoing IDE clinical trial in the United States of America. The U.S Food and Drug Administration (FDA) has fully approved the ...

AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FDA

WILMINGTON, Del., Sept. 22 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the United States Food and Drug Administration (FDA) has granted an additional six-month period of exclusivity to market CASODEX(R) (bicalutamide) for its licensed advanced prostate cancer indication until Ap...

New Data Support Earlier Suggested Guidance for Levels of Cell-Mediated Immunity in Pediatric Liver Transplant Patients

Cylex's ImmuKnow(R) assay suggests clinical potential in independent study of pediatric liver transplant patients COLUMBIA, Md., Aug. 21 /PRNewswire/ -- Israeli et al.,* in an article just published in the peer-reviewed journal Liver Transplantation, have further developed our u...

Novare Announces Completion of First Pediatric Single Port Spleen Removal Using RealHand(R) HD Instruments

8-year-old patient receives 'hidden scar' procedure; Pediatrics becomes 4th surgical specialty to benefit from single port surgery with RealHand HD instruments CUPERTINO, Calif., July 28 /PRNewswire/ -- Novare Surgical Systems announced the successful completion of...

FDA Grants Pediatric Exclusivity for TOPAMAX(R), Extending the Marketing Exclusivity by Six Months

TITUSVILLE, N.J., July 24 /PRNewswire/ -- Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for TOPAMAX(R) (topiramate), based on studies submitted in response t...

Children's Brain Tumor Foundation's Tissue Bank Consortium May Solve Dire Problem in Pediatric Cancer Research

Leading Institutions in Philadelphia, Pittsburgh and Chicago To Launch Collaborative Initiative NEW YORK, July 1 /PRNewswire-USNewswire/ -- In a major effort to speed treatment and cures for pediatric brain tumors and cancer, the Children's Brain Tumor Foundation (CBTF) today launched the in...

Phase 3 Data Regarding Anti-RSV Antibody To Be Presented at Pediatric Academic Societies (PAS) Annual Meeting

- In Clinical Trial, Motavizumab Reduced Hospitalizations Due to Respiratory Syncytial Virus by 83 Percent Compared to Placebo - HONOLULU, May 4 /PRNewswire/ -- MedImmune today announced that researchers are currently presenting results from a MedImmune-sponsored Phase 3 study involving...

MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate

Lower systemic drug exposure observed compared to currently marketed conventional nebulized budesonide MOUNTAIN VIEW, Calif., March 24 /PRNewswire-FirstCall/ -- MAP Pharmaceuticals, Inc. (Nasdaq: MAPP ) announced today that in a pharmacokinetic clinical trial Unit Dose Bud...

U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

- Otsuka-sponsored Study Evaluated Use of ABILIFY In This Patient Population - TOKYO and PRINCETON, N.J., Feb. 29 /PRNewswire/ -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY ) announced today that the U.S. Food and Drug Administr...

Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder

Shows Treatment Significantly Effective at Eight Weeks CINCINNATI, Oct. 26 /PRNewswire/ -- In the largest pediatric study of its kind on mood stabilizers, scientists from Cincinnati Children's Hospital Medical Center and two other centers demonstrated that divalproex sodium (Depakote(...

Replidyne Phase II Pediatric Trial Meets Primary Objective

LOUISVILLE, Colo., March 06, 2007 /PRNewswire-FirstCall/ -- Replidyne, Inc. announced today that it has completed its Phase II clinical trial using faropenem medoxomil (faropenem) in pediatric patients with acute otitis media (AOM), a common infection of the middle ear. Initial analyses of the stu...

New Studies Evaluating NexiumIn Pediatric GERD To Be Presented At Annual Digestive Disease Week Meeting

AstraZeneca Focuses Research on Growing Childhood Condition WASHINGTON, May 22, 2007 /PRNewswire-FirstCall/ -- AstraZeneca will present several studies today regarding pediatric patients with gastroesophageal reflux disease (GERD) during oral and poster sessions at the annual Digestive Disease Wee...

Neuroblastoma Expert Reviews Progress and Challenges in Fighting Difficult Pediatric Cancer

PHILADELPHIA, June 25, 2007 /PRNewswire-USNewswire/ -- Childhood cancers are fortunately rare, but among them, neuroblastoma is a special case, accounting for 7 percent of all childhood cancers, but 15 percent of childhood cancer deaths. It typically occurs as a solid tumor in the abdomen, but als...

Generex Biotechnology to Make Presentations At 46th Annual Meeting of the European Society of Pediatric Endocrinology

WORCESTER, Mass., Jun 27, 2007 (PrimeNewswire via COMTEX News Network) -- Generex Biotechnology Corporation (Nasdaq:GNBT), the leader in drug delivery for metabolic diseases through the inner lining of the mouth, announced today that it will be making three poster presentations at the 46th Annual ...

Tiny Cup Attached to Eye Improves Drug Delivery For Retinal Diseases

...patient and outpatient services. It is the largest pediatric ophthalmology program in the nation with multiple ... States and around the world for its leadership in pediatric and adolescent health. Children's Hospital is one ... California since 1932. It is a national leader in pediatric research. For more information, see www.Th...

2,500 Cases Completed With the Magnetic Irrigated Catheter

...hese include ablations of a wide variety of cardiac arrhythmias in all four chambers of the heart and across a broad spectrum of patients ranging from pediatric to geriatric. Included in the Niobe clinical experience are several very compelling procedures in patients with congenital heart defects and patients ...

Diabetes Gene Raises Odds of Lower Birth Weight

...PHILADELPHIA, July 29 /PRNewswire-USNewswire/ -- pediatric researchers have found that a gene previously show...adelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to ...eptional patient care, training new generations of pediatric healthcare professionals and pioneering major rese...

Injection Reverses Heart-Attack Damage

..., the study's senior investigator and a practicing pediatric cardiologist at Children's since 2007. Wh...world ' s largest research enterprise based at a pediatric medical center, where its discoveries have benefit...ston today is a 397-bed comprehensive center for pediatric and adolescent health care grounded in the values ...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

...f decreased bone mass should be monitored. Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents ta...

Risks of Delaying ACL Reconstruction in Young Athletes May Be Too High, Study Shows

...reatment until closer to skeletal maturity. Our study measured the independent risk factors for and relative risk of meniscal and chondral injuries in pediatric ACL patients," said author, Theodore J. Ganley, MD, Director of the Sports Medicine and Performance Center for The Children's Hospital of Pennsylvani...

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

...sk of decreased bone mass should be monitored. Inhaled steroids, including ASMANEX, may cause a reduction in growth velocity when administered to pediatric patients. The long-term effect on final adult height is unknown. Health care providers should closely follow the growth of children and adolescents ta...

Current Status of the Development Programs of New Indications and Formulations for Aricept(R) for Enhancing Patient Value

...tration (FDA) in August or September 2009. 2. pediatric Use Eisai filed a Proposed pediatric Study Request (PPSR), an application that proposes a rationale and study design for pediatric studies, with the U.S. FDA in February 2009 to eva...

Cephalon Submits NUVIGIL Supplemental New Drug Application for the Treatment of Excessive Sleepiness Associated with Jet Lag Disorder

... modafinil, a racemic mixture of S- and R-modafinil (the latter is armodafinil, the active ingredient in NUVIGIL). NUVIGIL is not approved for use in pediatric patients for any indication. The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, diz...

MedImmune Funds Study to Help Gain Insights Into Full Burden of RSV Disease Among Premature Infants

... in Outpatient Setting During First Year of Life; Reinforcing Commitment to pediatric Research GAITHERSBURG, Md., June 29 /PRNewswire/ -- MedImmune continues to advance its commitment to pediatric research with today's announcement of the first observational prospective s...

More Gene Mutations Linked to Autism Risk

...adelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to ...eptional patient care, training new generations of pediatric healthcare professionals and pioneering major rese...veries that have benefited children worldwide. Its pediatric research program is among the largest in the count...

ADHD Genes Found; Known to Play Roles in Neurodevelopment

...PHILADELPHIA , June 23 /PRNewswire-USNewswire/ -- pediatric researchers have identified hundreds of gene varia...rawing on DNA samples from the Children's Hospital pediatric network, the researchers analyzed genomes from 335...adelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to ...

Gene Findings Unlocking Reasons for Neuroblastoma Risk

...thers." In the largest gene study to date in pediatric oncology, Maris's study team performed a genome-wi...e genetic landscape of neuroblastoma, added Maris, pediatric oncologists can better develop more precise target...nation's largest research and clinical programs in pediatric oncology. DNA samples for both studies were p...

FDA Advisory Committee Votes in Favor of Zyprexa for Two Adolescent Indications

...template=/ContentManagement/ContentDisplay.cfm&ContentID=10430 . Accessed 4.20.09 (2) The Child & Adolescent Bipolar Foundation. About pediatric Bipolar Disorder. Available at: http://www.bpkids.org/site/PageServer?pagename=lrn_about . Accessed May 4, 2009. (3) The National Institute...

WORLD'S First Robotic Assisted Kidney Transplant Performed at Saint Barnabas Medical Center

...ansplant surgery has led him to achieve medical "firsts" in New Jersey regarding transplant surgery, including performing a transplant on the youngest pediatric patient in the state, performing New Jersey's first laparoscopic kidney donation surgery, and performing the state's first isolated pancreas transplan...

Lupus Foundation of America Fosters the Next Generation of Lupus Researchers by Awarding Gina M. Finzi Memorial Student Summer Fellowships to Five Students

...Anti-NMDAR Antibody" Maggie Bromberg, Duke University Medical Center (Durham, NC ) "Psychological and Disease Related Predictors of Sleep in pediatric SLE" Tarak Trivedi, The University of Chicago (Chicago, IL) "Analysis of SLE Clinical Characteristics Using SLE Susceptibility Genes" T...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

...e. REMICADE is also approved for the treatment of pediatric patients with moderately to severely active Crohn'...500,000 Americans, including approximately 150,000 pediatric patients. The cause of Crohn's disease is not kno...soriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The sa...

Prometheus Announces New Findings Regarding Patients at Risk for Celiac Disease at DDW

...redisposed individuals actually develop the disease, despite gluten ingestion, for reasons that are not well understood," said Dr. Michelle Pietzak, a pediatric Gastroenterologist in the Division of Gastroenterology at the University of Southern California Keck School of Medicine. "The results from this stud...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

...ew York as well as Duke University and the Piedmont Research Center, both in North Carolina. The tumor assessment studies were conducted using both pediatric and adult human brain tumor xenografts. The mouse tumor models demonstrated statistically significant tumor regression and prolongation of survival f...

Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients

...s Hospital in Ohio conducted a retrospective study to assess the role of the ImmuKnow assay in viral surveillance and immune function monitoring in 35 pediatric renal transplant patients. "Among the 5 patients who became positive for EBV or BK virus," explained Dr. Imam, "each event was preceded by a devi...