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Initiation in Medical Technology

SIMPONI(TM) (golimumab) Receives Positive Opinion From CHMP for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

... treatment should be carefully considered before initiation of SIMPONI therapy. Patients must be evaluated ... (TB), including latent tuberculosis, prior to initiation of SIMPONI. If active TB is diagnosed, SIMPONI ... evaluated and monitored prior to the initiation of, during treatment with, and for several months ...

First Candidate from Esperance's Targeted Anti-cancer Platform, EP-100, Establishes Preclinical Proof of Concept

... - Company plans initiation of clinical studies; Data to be presented at AACR ... Company's preclinical program that support the initiation of clinical trials in cancer. EP-100 is the first ... these studies, Esperance is actively planning the initiation of a Phase 1 clinical trial of EP-100 in patients ...

Scientists Discover Why Teeth Form in a Single Row

... it was indeed the mesenchyme that carried tooth initiation signals later in development, but how those ... 4 (BMP4) to be an important factor for the initiation of teeth, and that a protein called Msx1 ... regulation of competing pro- and anti-tooth initiation signals controls how mammalian teeth come one by ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... reticulin fibers within the bone marrow. Prior to initiation of PROMACTA, examine the peripheral blood smear ... discontinuation of PROMACTA therapy. Prior to the initiation of PROMACTA, examine the peripheral blood ... AST, total and fractionated bilirubin) prior to initiation of PROMACTA, every 2 weeks during the dose ...

New Data Presented at WCTRIMS* Supports the Importance of Early and Sustained Treatment with Betaseron(R)

... Earlier treatment initiation and longer exposure to Betaseron was associated ... Sclerosis (WCTRIMS) demonstrated that early initiation of Betaseron(R) (interferon beta-1b) treatment ... the relationship between timing of drug initiation and length of exposure to treatment, and ...

Merck Serono Announces Initiation of the ORACLE MS Trial to Evaluate Cladribine Tablets in Patients at Risk of Developing Multiple Sclerosis

... Darmstadt, Germany, announced today the initiation of a Phase III trial to evaluate the therapeutic ... "There is increasing evidence supporting the initiation of treatment with a disease-modifying drug in ... President, Global Marketing, Merck Serono. "The initiation of the ORACLE MS study further demonstrates our ...

M. D. Anderson to Initiate Clinical Validation Study on Rosetta Genomics' MicroRNA-based Diagnostic Assay Identifying the Origin of Cancer Metastases

... and therapeutic products, announced today the initiation of a clinical validation study with ... in the second half of 2008. "The initiation of this validation study is an integral part of ... and CEO of Rosetta Genomics. "We believe the initiation of this study for our CUP assay with a leading ...

Human Genome Sciences Reports Progress With Late-Stage Products and New Initiatives

... and causing the cancer cells to die. The initiation of dosing is imminent in a Phase 1 clinical trial ... alliance(s) for TRAIL receptor antibodies. -- initiation of HGS1029 Phase 1 trial in solid tumors imminent. -- initiation of HGS-ETR1 randomized trial in hepatocellular ...

PTC Therapeutics Announces Initiation of Phase 2b Registration-Directed Clinical Trial of PTC124 in Duchenne/Becker Muscular Dystrophy

... PTC Therapeutics, Inc. (PTC), today announced the initiation of an international pivotal trial of PTC124 in ... monitored. "We are very pleased to announce the initiation of the Phase 2b trial for PTC124 in boys with ... Our future plans for PTC124 include the initiation of longer-term studies in CF, as well as ...

Financial Results for Full Year 2007: NicOx Significantly Advances Clinical Programs

... during the year. NicOx also announced today the initiation of two large Ambulatory Blood Pressure Monitoring ... press release). Key highlights 2007: -- initiation of the two remaining pivotal phase 3 trials for ... Heart Association (the 104 study) -- initiation of a phase 2 proof-of-concept study designed to ...

Sangamo BioSciences Reports 2007 Fourth Quarter and Year-End Financial Results

... endothelial growth factor-A (VEGF-A) gene. -- initiation of additional Phase 2 clinical trials of SB-509 ... In April, Sangamo announced the initiation of a randomized, single-blind, ... uncertainties related to the timing of initiation and completion of clinical trials, whether ...

PTC Therapeutics Presents Encouraging Phase 1 Results of its Novel VEGF Inhibitor, PTC299, at 30th Annual San Antonio Breast Cancer Symposium

... presented today formed the basis for the recent initiation of a Phase 1b/2 clinical trial of PTC299 in ... Phase 1a clinical data have supported the recent initiation of a randomized, dose-ranging Phase 1b/2 ... and search using the keyword, PTC299. "The initiation of trials with PTC299 in patients with breast ...

Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout

... (Nasdaq: RDEA ) today announced the initiation of a new clinical development program directed ... announced today, include the following: -- initiation of a Phase 2a proof-of-concept trial in HIV ... RDEA806, in the fourth quarter of 2007; -- initiation of a Phase 1 trial in advanced cancer patients ...

Retrospective Analysis Finds That Initiation of Insulin Glargine in Patients With Type 2 Diabetes was Associated With a Lower Incidence Rate of Myocardial Infarction as Compared With NPH Insulin

... national managed care database found that the initiation of insulin therapy with insulin glargine was ... (MI) events (defined by ICD-9 codes) following initiation of glargine versus NPH, after adjusting ... attenuate the association of insulin initiation with subsequent MI incidence. This retrospective ...

Dynavax Begins TOLAMBA(TM) Environmental Exposure Chamber Study

... will be due in July 2010. The initiation of dosing in the TOLAMBA chamber study triggered ... or delays in research and development, initiation and completion of clinical trials, the results ... trials and the impact of those results on the initiation and completion of subsequent trials and issues ...

Genzyme and Bayer Schering Pharma AG, Germany Announce Start of Phase 3 Program with Alemtuzumab for Treatment of Multiple Sclerosis

... currently available disease-modifying therapies. initiation of this Phase 3 program follows the successful ... statements, including statements about the initiation of clinical trials, regulatory plans and expected timelines for alemtuzumab, including the initiation of a second Phase 3 trial in MS patients and the ...

Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule

... safety initiation in Fourth ... safety initiation in Fourth ... including, without limitation: delays in the initiation or completion of enrollment in the company's ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... (TASKi1), the onset of effect of R788 occurred within one week after the initiation of therapy and was maintained. The most frequent adverse events were ... +0.2/+0.3 +0.6/+1.4 Mean Systolic BP if had Adjustment or initiation of BP Medication (mmHg) # Had BP Meds Adjusted/Initiated 11 ...

CoAxia, Inc. Announces $21.5M Series D Financing

... of NeuroFlo in combination with a variety of stroke devices and drugs, and initiation of marketing. CoAxia President & CEO Andrew M. Weiss stated, "We ... that we are now well positioned for trial completion, PMA submission and initiation of sales and marketing." Antoine Papiernik, Managing Partner at ...

Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients

... promising solid tumor indications for further study in Phase 2. The recent initiation of Phase 1 studies in multiple myeloma and leukemia will allow us to ... where preclinical data have been encouraging. These data and the initiation of additional studies have added significant value to the program and, in ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... shock/left ventricular dysfunction have been associated with the initiation of imatinib therapy. The condition was reported to be reversible with the ... for 1-2 weeks concomitantly with imatinib should be considered at the initiation of therapy. Bullous dermatologic reactions (eg, erythema multiforme ...

ANA598 Demonstrates Potent Antiviral Activity at all Dose Levels in Completed Phase Ib Study in Hepatitis C Patients

... with pegylated interferon and ribavirin. The actual timing for the initiation of Phase II studies may depend on a number of factors, including FDA ... Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In December ...

Pfizer and Medivation Initiate Phase 3 Trial of Dimebon Added to Donepezil in Patients with Alzheimer's Disease

... PFE ) and Medivation, Inc. (Nasdaq: MDVN ) today announced the initiation of a 12-month, Phase 3 clinical trial of the investigational drug Dimebon. ... forward-looking statements, including statements regarding the timing of: initiation of clinical studies, filing of an NDA for Dimebon, the presentation of ...

Intercell Starts a Phase I Clinical Trial for a New Streptococcus pneumoniae Vaccine

... - initiation of a first-in-man Phase I clinical trial in healthy subjects - Study ... with or without the addition of an adjuvant will be tested. "The initiation of this clinical Phase I trial is an important step to further strengthen ...

Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical Development

... SGP ), today announced that it has reached an important milestone with the initiation of its first-in-human clinical development program for SCH 900795, a new ... tool in the prevention against seasonal Influenza illness." The initiation of the clinical development program of SCH 900795 represents Nobilon's ...

Aerovance Initiates Phase IIb Clinical Trial with Aerovant(TM) for the Treatment of Uncontrolled Asthma

... dry powder Aerovant in patients with uncontrolled asthma. Study initiation begins today in the United States for AeroTrial, a double-blind, ... of expired nitric oxide (FeNO). "Regulatory clearance and initiation of AeroTrial are significant milestones for Aerovance and potentially for ...

Human Genome Sciences Announces Fourth-Quarter and Full-Year 2008 Financial Results and Key Developments

... said H. Thomas Watkins, President and Chief Executive Officer. "With initiation of the delivery of ABthrax to the Strategic National Stockpile in late ... HGS to Receive $9 Million Milestone In February 2009, GSK announced initiation of a Phase 3 clinical trial program to evaluate the efficacy, safety and ...

Inspiration Biopharmaceuticals, Inc. Initiates Phase 1 Clinical Trial of IB1001 for the Treatment of Hemophilia B

... /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc., today announced the initiation of a Phase 1 clinical trial of IB1001, an intravenous (IV) recombinant ... 2/3 trial either based on an on-demand or prophylaxis protocol. "The initiation of this Phase 1 trial is an important milestone for the Company and for ...

ESBATech's Antibody Fragment Enters Phase Ib/IIa in Ophthalmology

... a leading developer of antibody fragment therapeutics, today announced the initiation of a Phase Ib/IIa study in patients undergoing cataract surgery. This ... Development at ESBATech AG, commented, "We are very excited to report the initiation of this study. TNF-alpha is a well known and well characterized drug ...

Solace Pharmaceuticals Initiates Phase IIa Trial of Glial Cell Modulator SLC022 in Post-Herpetic Neuralgia

... discovering and developing innovative treatments for pain, announced the initiation of a proof-of-concept clinical trial of SLC022 in patients with ... pain based on their active role in neuronal pain signaling. "The initiation of this study is another important milestone for Solace in our drive to ...

Quark Pharmaceuticals Announces Dosing of the First Patient in Phase I/II Clinical Trial for Systemically Delivered siRNA Drug Candidate for Delayed Graft Function

... Shai Erlich, Ph.D., Chief Medical Officer of Quark, commented, "The initiation of patient dosing with QPI-1002 is an important milestone for Quark as ... Zurr, Chief Executive Officer, commented, "We are very pleased to announce initiation of human dosing of the systemically administered QPI-1002 in our Phase ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... a risk of bone marrow fibrosis with cytopenias. -- Prior to initiation of Nplate examine the peripheral blood smear closely to establish a ... and following discontinuation of Nplate therapy. -- Prior to the initiation of Nplate, examine the peripheral blood differential to establish the ...

Raptor Pharmaceuticals Announces Phase 2a Clinical Trial Initiation in Non-Alcoholic Steatohepatitis (NASH)

... or the "Company") (OTC Bulletin Board: RPTP), today announced the initiation of patient dosing in a Phase 2a clinical trial, in collaboration with the ... at UCSD and principal investigator for the NASH study, commented, "The initiation of patient dosing in the NASH trial offers the opportunity to evaluate ...

Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients

... 2008 certain non-clinical activities for the ANA598 program, including the initiation of these long-term toxicology studies and the manufacture of additional ... Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In the ...

SARcode and Sunesis Announce Start of Phase 1 Clinical Trial in Ocular Inflammatory Diseases

... and Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today announced SARcode's initiation of a Phase 1 clinical trial of a small molecule LFA-1 product candidate ... convertible note. The next payable milestone, if earned, will be for initiation of the Phase 2 clinical program. About SARcode SARcode is a ...

Amicus Therapeutics Announces Second Quarter 2008 Financial Results

... Successful End of Phase 2 Meeting with the FDA for the Fabry Program and initiation of Phase 2 Clinical Trial in Pompe are Highlights for the ... Phase 1 clinical trials for AT2220 for the treatment of Pompe disease, the initiation of Phase 2 clinical development of AT2220 for the treatment of Pompe ...

Tolerx Initiates Dosing of Otelixizumab, a Novel Type 1 Diabetes Agent, in DEFEND, a Phase 3 Clinical Trial

... of novel therapies for immune-mediated diseases, today announced the initiation of a pivotal Phase 3 clinical trial that is evaluating otelixizumab in autoimmune new onset type 1 diabetes. As a result of the initiation of patient dosing in DEFEND (Durable Response Therapy Evaluation For Early ...

HUYA Bioscience Int'l Announces Pre-IND Outcome for HBI-3000 - Promising Anti-Arrhythmia Compound Sourced From China

... information' that will support the submission of a U.S. IND and the initiation of a U.S. Phase I trial. HUYA anticipates filing an IND application for ... that the FDA will accept Chinese data to support clinical study design and initiation in the U.S., as this validates our co-development method," said Mireille ...

Arno Therapeutics, Inc. Completes $18 Million Financing and Reverse Merger with Laurier International, Inc.

... tumors is currently ongoing. Multiple Phase II studies are planned for initiation in 2008 in a variety of cancers, including glioblastoma multiforme (GBM), ... adequate supplies and expertise to support manufacture of drug product for initiation and completion of our clinical studies; risks relating to the transfer of ...

New Data Offers Insights Into the Potential Role for TYKERB(R) (Lapatinib) in Non-Cytotoxic Chemotherapy-Based Treatment Regimens

... is uncertain. The hepatotoxicity may occur days to several months after initiation of treatment. Liver function tests should be monitored before initiation of treatment, every 4 to 6 weeks during treatment, and as ...
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