Clinical in Medical Technology

Sanofi Pasteur Submits Supplemental Application for A(H1N1) Pandemic Vaccine to U.S. FDA

... while at the same time, continue the important clinical studies of our vaccine." The supplemental ... are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the ...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

... 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, ... legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber ... length of time that it takes for us to complete clinical trials and obtain regulatory approval for product ...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... in patients with type 2 diabetes Begin clinical trials on at least one additional drug in 2009; clinical trials already initiated on three drugs this year ... milestone payment from Alnylam for initiation of clinical trials on ALN-VSP. Isis earned $1.4 ...

Cancer Centers of North Carolina Offers HDR Brachytherapy for Treatment of Cancerous Tumors

... and pharmacy services, and an extensive clinical trials program connecting patients to leading ... access to the latest advancements in therapies, clinical research and technology, as well as best-in-class clinical and operational processes that help to advance ...

SIRO Clinpharm Completes Successful Implementation of Oracle Life Sciences Application Suite

... Suite (OLSAS) by going live with Oracle Siebel clinical Trial Management System and Oracle Adverse Events ... "This will help us manage critical tasks in clinical operations and drug safety in an efficient and ... had gone live with the industry standard Oracle clinical and Oracle RDC, integrated with TMS for ...

Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis

... The objective of the 221-patient Phase 2 clinical trial was to assess safety and evaluate the ... "These data are consistent with the clinical hypothesis for BA058--greater gains in BMD at the ... debilitating disease." About the Phase 2 clinical Trial The Phase 2 randomized, placebo- and ...

Labopharm files New Drug Submission with Health Canada for novel antidepressant

... a North American Phase III placebo controlled clinical trial (study 04ACL3-001), which enrolled more ... including the HAMD-17 depressed mood item, the clinical Global Impressions Severity (CGI-S) scale, the ... of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an ...

NOVAVAX Achieves Pandemic H1N1 Influenza Production Milestone

... of the pandemic H1N1 VLP vaccine to support human clinical studies and stands ready to assist with ... working concurrently to produce materials for a clinical study in the elderly population with our Seasonal ... Inc has successfully completed a Phase I/IIa clinical study with a candidate H5N1 influenza VLP vaccine ...

Nektar Therapeutics Reports Second Quarter 2009 Financial Results

... we made a strong commitment to advancing our clinical pipeline," stated Howard W. Robin, President and ... Officer of Nektar. "We completed our Phase 2 clinical program for NKTR-118, and we are poised to report ... million of investment in Nektar preclinical and clinical development programs. Revenue for the ...

ARUP Laboratories Applauds FDA's Decision on the Value of KRAS-Mutation Testing in Colorectal Cancer

... /PRNewswire/ -- ARUP Laboratories , a national clinical and anatomic pathology reference laboratory and a ... Laboratories ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and ... led by the efforts of the ARUP Institute for clinical & Experimental Pathology(R). Further ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... 15 minute infusion every four weeks. In clinical trials thus far to test new medications for bone ... fully human monoclonal antibody in late stage clinical development that specifically targets RANK ... have been enrolled in the denosumab oncology clinical trials testing the drug for bone loss and ...

Project Zero Delay Accelerates Drug's Path to Clinical Trial

... Del., Aug. 3 /PRNewswire-FirstCall/ -- A phase I clinical trial enrolled its first patient only two days ... have reported their work in the Journal of clinical Oncology published online on August 3(rd). ... Delay addressed one aspect of drug development -- clinical trial start-up time," Kurzrock said. "Substantial ...

TWO NEW KLRI PEER-REVIEWED PUBLICATIONS: Hormone Therapy May Reduce Atherosclerosis in Women Close to Menopause; Growth Hormone May Increase Risk of Diabetes, Improve Lipid Profile in Men

... began menopausal HT use much later than in usual clinical practice--beginning trials on women of a median ... Another KLRI study, appearing in the Journal of clinical Endocrinology and Metabolism and led by Marc ... organization that conducts state-of-the-art clinical translational research on the prevention of ...

Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... to relapse," said Henry A. Nasrallah, M.D., a clinical investigator who worked on the INVEGA(R) SUSTENNA(TM) clinical trials, and a Professor of Psychiatry and ... medication compliance, which may help optimize clinical outcomes in schizophrenia." The approval ...

Access Pharmaceuticals Provides Update on ProLindac Clinical Development Program

... Board: ACCP), provided an update today on its clinical development strategy for ProLindac , a novel ... shown to be active in many solid tumors in human clinical studies. Access has commenced a new clinical study of ProLindac in France. The study will ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... of the velaglucerase alfa program from both a clinical and regulatory perspective," said Sylvie ... largest and most comprehensive set of Phase III clinical trials conducted to date for Gaucher disease. ... around the world have participated in the clinical studies. Velaglucerase alfa is made using ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... positive preliminary results from its phase I clinical trial of PSI-7851 for the treatment of hepatitis ... for chronic HCV infections, is in a Phase 2b clinical trial in combination with Pegasys(R) plus ... and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic ...

Covance Receives Highest Level of Phase I Accreditation

... supplementary accreditation for the conduct of clinical pharmacology in Europe by the Medicines and ... This voluntary accreditation process provides clinical trial volunteers and sponsors with confidence ... This accreditation was awarded to Covance's clinical research unit in Leeds, United Kingdom, where the ...

FDA Advisory Committee Votes in Favor of SAPHRIS(R) (asenapine) for Acute Bipolar I Disorder and Acute Schizophrenia

... Schering-Plough Research Institute. "In clinical studies, SAPHRIS has demonstrated efficacy ... (NDA) for SAPHRIS includes efficacy data from a clinical trial program involving more than 3,000 patients ... Act of 1995, including statements relating to the clinical development of, the commercial plans for and the ...

Montefiore Medical Center and Albert Einstein College of Medicine Herald New Agreement To Continue Forty-Plus Year Historic Relationship

... outlines an increased level of commitment to clinical care, research and education NEW YORK, ... existing partnership and strengthen their ties in clinical care, medical research and teaching. The two ... to recruit the best and brightest faculty and clinical staff in the nation; to spearhead ...

European Division of Global Top 20 Pharmaceutical Company Awards Phase III Trial to DATATRAK

... focused on global eClinical solutions for the clinical trials industry, today announced that a European ... eClinical(TM) Solution to conduct a Phase III clinical trial. DATATRAK has executed a letter of intent with one of the world's leading global clinical research organizations (CRO) to begin trial ...

Dirucotide Does Not Meet Primary Endpoint in Phase III MAESTRO-01 Trial in Secondary Progressive Multiple Sclerosis

... also announced they would discontinue ongoing clinical trials - including MAESTRO-02 and MAESTRO-03 - ... MAESTRO-03 is a 510-patient U.S. Phase III clinical trial designed to evaluate dirucotide for the ... this result and will be working closely with our clinical team to evaluate these data and the available ...

Wyeth Reports Publication of Phase 3 Data for Bazedoxifene/Conjugated Estrogens, an Investigational Compound Being Studied for the Treatment of Menopausal Symptoms

... Fertility and Sterility of data from a Phase 3 clinical study that showed that the investigational ... enopause A nd R esponse to T herapy (SMART-1) clinical trial. SMART-1 was designed to explore the ... with placebo. In this study, analysis of most clinical laboratory determinations revealed no clinically ...

Unlikely Treatment Identified by BrainCells Neurogenesis Platform Improved Clinical Outcomes in Patients Suffering From Depression

... diseases, announced today results from the first clinical proof-of-concept study of BCI-952, a combination ... of Mental Health and the American Society of clinical Psychopharmacology. Neurogenesis is the process ... "Our study results provide the first prospective clinical validation of neurogenesis as a target for the ...

Correction to Earlier Release From Jewish Hospital and University of Louisville

... the world's first phase-one FDA-approved clinical trial using "c-kit-positive" adult cardiac stem cells to treat heart disease. The clinical trial is being conducted by a team of University ... for Molecular Cardiology, stated, "Another clinical trial is being conducted at another facility. ...

World's First Cardiac Adult Stem Cell Patient Receives Infusion

... 17 marks the world's first phase-one FDA-approved clinical trial using adult cardiac stem cells to treat heart disease. The clinical trial is being conducted by a team of University ... to enroll patients in this first-of-its-kind clinical trial. We hope to help the heart regenerate its ...

NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study

... today the preliminary results of a short-term clinical study (Study C123) of Qutenza(TM) in patients ... the topical agent used as a pretreatment in the clinical development program. The NDA for Qutenza in PHN ... Medical Officer commented, "I am grateful to our clinical investigators and the entire NeurogesX team for ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... ) today announced that in the TASKi3 Phase 2b clinical trial in rheumatoid arthritis (RA) patients who ... different). TASKi3 was the first clinical trial evaluating R788 in which anatomical changes ... doses of methotrexate throughout the clinical trial. MRI Results TASKi3 Mean Change ...

First Skin Cancer Patients Treated With Electronic Brachytherapy (eBx) At University of Wisconsin Riverview Cancer Center

... M.D., the center's radiation oncologist and a clinical professor in the Department of Human Oncology and ... without the use of a radioactive isotope and in clinical settings where a shielded vault is not needed. ... practice of radiation oncology in virtually any clinical setting, eliminating the need for heavily ...

Researchers Create First Targeted Knockout Rats Using Zinc Finger Nuclease Technology

... cells and zebrafish embryos and are now in human clinical trials for the treatment of HIV/AIDS. This is ... development program is currently in Phase 2 clinical trials for evaluation of safety and clinical effect in patients with diabetic neuropathy and ...

Lilly and New York City Mayor Michael R. Bloomberg Announce Lilly Agrees to be First Tenant of East River Science Park; Issue Urgent Call for Healthcare Reform that Protects Innovation and Jobs

... company's total number of oncology molecules in clinical development to 23 and the number of unique ... discovery efforts that have produced the clinical product candidates in ImClone's robust pipeline ... increasing the number of ImClone molecules in clinical development to six; and ImClone also ...

Poniard Pharmaceuticals Announces Positive Cardiac Safety Data From Picoplatin Phase 1 Trial Supporting NDA Filing

... picoplatin. The trial was conducted at seven clinical sites in the United States. Results showed no clinical cardiac-related events. In addition, no evidence ... 1,100 cancer patients have received picoplatin in clinical studies to date. Additional safety and ...

Lexicon's Drug Candidate LX1032 for Carcinoid Syndrome Receives Orphan Drug Designation From EMEA

... for marketing approval, and assistance with clinical trial design. LX1032 is the first drug candidate ... Brown , M.D., J.D., senior vice president of clinical development at Lexicon. "We are now well ... Lexicon recently initiated a Phase 2 clinical trial of LX1032 in the United States to evaluate ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... Ueno, Ltd. announced on July 17 that as a phase 1 clinical study on the new compound RK-023 that is being ... below) has been completed. The phase 1 clinical study of RK-023 consisted of a patch test (open, ... announce the successful completion of a phase 1 clinical study on our self-developed RK-023 that focuses ...

FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent

... of Tekturna HCT as initial therapy was based on clinical trial data involving more than 2,700 patients, ... of Tekturna is being studied in an extensive clinical program, including outcomes trials, known as ... The FDA approvals of Tekturna HCT were based on a clinical trial program involving over 6,200 patients and ...

National Cancer Institute Research Identifies Unique Mechanism of Brostallicin's Anti-Tumor Effectiveness

... the risks associated with preclinical and clinical developments in the biopharmaceutical industry in ... of the preclinical results to predict results in clinical trials, the failure of the mechanism to be ... profile, the failure of the bio-marker to guide clinical trials, the potential failure of ...

UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPar's Investigational Cancer Drug BSI-201

... Cancer Research Committee, associate director for clinical research for US Oncology and co-director of ... 45th Annual Meeting of the American Society of clinical Oncology (ASCO) held May 29-June 2, 2009, in ... "We are very pleased to be participating in this clinical trial of BSI-201 which is a very promising new ...

Idenix Pharmaceuticals Successfully Completes Proof-of-Concept Study of IDX184 for the Treatment of Hepatitis C Virus (HCV)

... the optimal IDX184 doses to advance into broader clinical trials." In the 75 and 100 mg/day ... implied statements with respect to the company's clinical development programs or commercialization ... IDX184, the likelihood and success of any future clinical trials involving IDX184 or successful development ...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

... diabetes medications. This 26-week open-label clinical study compared exenatide once weekly to ... unexpected new data; safety and technical issues; clinical trials, including the clinical trial mentioned in this press release, not being ...

Cytokine PharmaSciences Initiates Phase I Study of Oral Anti-Inflammatory Agent, CPSI-2364

... proof-of-concept studies that led to human clinical trials. An intravenous formulation of semapimod ... anti-inflammatory activity in Phase II clinical trials in Crohn's disease, psoriasis and ... Cytokine PharmaSciences has three products in clinical development and employs 70 people at its ...