Assessment in Biological Technology

AEterna Zentaris Partner, Keryx, Announces Agreement with FDA on a Special Protocol Assessment for Phase 3 Trial with Perifosine (KRX-0401) for the Treatment of Multiple Myeloma

QUEBEC CITY, Aug. 3 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS , TSX: AEZ), ("the Company") a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX ), its partner and licensee for perifosi...

OncoGenex Pharmaceuticals Completes Amendment to Phase 3 Special Protocol Assessment for Confirming Survival Benefit in Patients Receiving OGX-011 with First-Line Docetaxel for Metastatic Prostate Cancer

BOTHELL, WA, and VANCOUVER, June 24 /PRNewswire-FirstCall/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI ) announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) via the special protocol assessment process (SPA) on an amendment to the design ...

Serial Monitoring With ImmuKnow(R) is Useful in the Risk Assessment of Kidney Transplant Recipients

The results of this study will be presented during the American Transplant Congress in Boston, MA May 30 - June 3, 2009 COLUMBIA, Md., May 30 /PRNewswire/ -- Lead investigator, Dr. Manuel R. Carreno, along with his colleagues from the University of Miami , evaluated whether single or serial...

New Program Offers Breast Cancer Clinicians and Patients Support for Pre-Operative Clinical Assessment and Ongoing Surveillance of Lymphedema

NEWPORT NEWS, Va., and SAN DIEGO, Dec. 2 /PRNewswire/ -- The Patient Advocate Foundation (PAF), with support from ImpediMed Ltd. (ASX: IPD), is pleased to announce the launch of the Lymphedema CareLine (LCL). PAF, through its MedCare Division, is offering the national, toll-free patient/provider h...

4C Controls Announces the Appointment of Dr. Philip Hayden as Vice President, Security Assessment & Threat Analysis

4C Controls Inc. (OTCBB: FOUR.OB) today announced it has appointed FBI Supervising Special Agent (Ret.) Dr. Philip Hayden as its Vice President, Security Assessment & Threats Analysis. NEW YORK (Business Wire EON) August 18, 2008 -- Dr. Hayden comes to 4C Controls...

United BioSource Corporation and CogState Ltd. Form Strategic Partnership to Support Cognitive Assessment in Clinical Research

UBC Makes Strategic Investment in CogState Ltd. to Support Partnership Comprehensive service will standardize administration, measurement and global implementation of cognitive testing in clinical trials BETHESDA, Md., Aug. 5 /PRNewswire/ -- Key points: -- United BioSource Corporat...

Simbionix Releases Powerful New Learning Management System With Enhanced True Assessment System(TM)

CLEVELAND, Ohio and DENVER, Colorado, July 16 /PRNewswire/ -- Simbionix' eLearning division, eTrinsic, announced the release of version 6.0 of their enhanced Learning Management System (LMS), incorporating the True Assessment System(TM) (TAS) for data reporting. Simbionix' LMS already delive...

OncoGenex receives completed Special Protocol Assessment for primary registration study of lead drug candidate OGX-011

VANCOUVER, July 14 /PRNewswire/ - OncoGenex Technologies Inc. announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting hormone refractory prostate ca...

Follow-up Phone Surveys: Effective Customer Service Assessment Tool for Improving Satisfaction

CHAPEL HILL, N.C., July 1 /PRNewswire/ -- To effectively measure customer satisfaction, follow-up CSR phone surveys garnered the highest rating of 3.93 out of 5 among customer service and call center executives in a member-driven research study conducted by Best Practices, LLC's GLOBAL BENCHMA...

Expert Consensus Panel Recommendation for Incorporating Lp-PLA2 Testing into Cardiovascular Disease Risk Assessment Guidelines

SOUTH SAN FRANCISCO, Calif., June 23 /PRNewswire/ -- diaDexus, Inc. today announced the release of a supplement to The American Journal of Cardiology, Vol. 101, No 12A June 16, 2008 that includes an expert consensus panel recommendation to include testing for lipoprotein-associated phospholipa...

Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial

Pivotal Trial in Medullary Thyroid Cancer Planned to Initiate This Summer SOUTH SAN FRANCISCO, Calif., June 16 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL ) announced today that the company and the U.S. Food and Drug Administration (FDA) have reached agreement on the phase 3 registr...

Perceptive Informatics Enhances Medical Imaging Capabilities for Assessment of Cardiac Function

BOSTON, June 2 /PRNewswire-FirstCall/ -- Perceptive Informatics, the technology subsidiary of PAREXEL International Corporation (Nasdaq: PRXL ), today announced that it has integrated its leading medical imaging technology with the functionality of DigiView, a specialized image management and...

FDA Agrees to Amend Dendreon's Special Protocol Assessment for Phase 3 IMPACT Study of PROVENGE

-Amended Agreement Accelerates Expected Timing of Final Analysis by One Year While Maintaining Comparable Powering of Interim and Final Results- -Dendreon to Hold Conference Call on Thursday, March 13, 2008 at 11:00 AM ET- SEATTLE, March 12 /PRNewswire-First...

Smart Genetics Announces Plans to Launch a New Alzheimer's Risk Assessment Service

Preeminent Team of Medical Advisers Helps Guide New Service Offering PHILADELPHIA, Feb. 7 /PRNewswire-USNewswire/ -- Smart Genetics today announced the planned launch of a new Alzheimer's risk assessment service with the appointment of a medical advisory board and a service agreement with ...

Agennix Receives Special Protocol Assessment Approval from FDA for the Pivotal Trial of Talactoferrin Alfa in First-Line Non-Small Cell Lung Cancer

Trial will also Support a Marketing Authorization Application in the European Union HOUSTON, Jan. 17 /PRNewswire/ -- Agennix Incorporated announced today that the U.S. Food and Drug Administration (FDA) has approved the design of a single, pivotal, Phase 3 trial e...

Statement on the Release of the European Food Safety Assessment on the Safety of Food Derived From Clones and Their Offspring in the Food Supply

Statement by Mark Walton, Ph.D., President, ViaGen January 11, 2008 WASHINGTON, Jan. 11 /PRNewswire-USNewswire/ -- "In light of the European Food Safety Authority's strong endorsement of the safety of food from clones and their offspring, we urge the U.S. Food and Drug Administration t...

ZymoGenetics and Merck Serono Receive FDA Special Protocol Assessment for Atacicept Pivotal Study in Lupus Nephritis

- Patient enrollment to begin in fourth quarter - SEATTLE, Oct. 4 /PRNewswire-FirstCall/ -- ZymoGenetics, Inc. (Nasdaq: ZGEN) today announced that, together with its collaborator Merck Serono, it has reached agreement with the U.S. Food and Drug Administration (FDA) on a Special Pro...

Harmonex Introduces CliniCom(TM), a Breakthrough in Psychiatric Intake and Assessment Technology

Advanced Artificial Intelligence Software Is Cost-Effective, Time-Saving ATLANTA, Oct. 1 /PRNewswire/ -- Harmonex Corporation today announced the formal launch of CliniCom(TM), a revolutionary software platform designed to assess children, adolescents and adults for possible psychiatric condit...

PDHI Launches Short Form of Its ConXus Profile Health Assessment

BERNARDSVILLE, N.J., March 16 /PRNewswire/ -- Protocol Driven Healthcare , Inc. (PDHI) now offers a short form of its health risk assessment (HRA), the ConXus(R) Profile. The shorter format facilitates completion by populations with low literacy and reduces processing costs of paper assessments...

The Coalition to Prevent Deep-Vein Thrombosis (DVT) RV Tour Takes to the Road to Educate the Nation About the Importance of DVT Risk Assessment

Driving to Reduce the Risks of DVT to Mark U.S. House of Representatives National Screening NEW YORK, March 10 /PRNewswire/ -- The Coalition to Prevent DVT today announced the launch of its first nationwide tour to raise public awareness about deep-vein thrombosis (DVT) and to encourage dial...

VAP(R) Cholesterol Test Bolsters Biophysical(R) Health Assessment

Biophysical Corporation adds advanced cholesterol testing capabilities BIRMINGHAM, Ala., July 31 /PRNewswire/ -- Atherotech, Inc., a cardio-diagnostic company, today announced that its VAP(R) Cholesterol Test is now included in Biophysical Corporation's newly released health assessment, Bioph...

International Council on Nanotechnology launches global research needs assessment

WASHINGTON - As nanotechnology has moved out of the laboratory and into commercial products, many have begun to question the impact of nanoscale materials on health and the environment. Learning more about such impacts, however, presents a daunting task, given the number of potential products, th...

EFFECTS OF INSTRUMENT RESOLUTION ON ASSESSMENT OF DNA PURITY

INTRODUCTION The traditional method for quantification and assessment of purity of DNA samples is spectrophotometric measurement at 260 and 280nm (1) . It is generally accepted that a sample of pure, double-stranded DNA of 50 g/mL will have an absorbance at 260nm o...

Is Z' factor the best assessment for the quality of cellular assays delivering higher content?

Elizabeth P. Roquemore, Sam Murphy, *Stephen J. Capper, Suzanne M. Hancock, Elaine Adie, Molly Price-Jones, Stephen Game & Stuart Swinburne Amersham Biosciences UK Limited, Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA England ...

Qualitative and Quantitative Assessment of Plasmid DNA Isolation, Rev A

Audra Day, Colette Schneider, Lisa Ottmers, and Brandt L. Schneider Department of Cell Biology and Biochemistry, Texas Tech University Health Sciences Center, Lubbock, TX 79430, USA. Introduction Small-scale isolation and purification of plasmi...

Fast, Accurate Assessment of siRNA-induced Gene Silencing

Cells-to-Signal Kit: Small Sample Prep for qRT-PCR Real-time, quantitative RT-PCR (qRT-PCR) is the most sensitive way to detect and quantitate mRNA and is often used to validate techniques that monitor ...

An Assessment of the Eppendorf twin.tec plate performance in PCR* applications

M. Arun Kumar, PhD, and Vincent Prezioso, PhD, Brinkmann BioSystems Laboratory Abstract To evaluate the performances of Eppendorf 96-well twin.tec PCR plates, we carried out PCR reactions with twin....

Reliable Assessment of Micronuclei for Genotoxicity Testing in Mice or Rats

Reliable Assessment of Micronuclei for Genotoxicity Testing in Mice or Rats Precise and cost-effective micronucleus analysis made easy with the icroFlow Micronucleus Analysis Kit Dorothea K. Torous Carol R. Tometsko Litron Laboratories, Rochester, N...

OncoGenex Reports Second Quarter 2009 Financial Results

...ther clinical investigation. - The Company reached an agreement with the U.S. Food and Drug Administration (FDA) via the special protocol assessment process (SPA) on an amendment to the design of a phase 3 registration trial of OGX-011. The FDA has agreed on modifications to the study...

Repligen Reports First Quarter Fiscal Year 2010 Financial Results

...in combination with magnetic resonance imaging (MRI) to improve the detection of pancreatic duct abnormalities compared to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis. This study is being conducted...

iCardiac Expands Sales and Marketing Team

... analysis and the industry's most sophisticated FDA-accepted cardiac safety assessment methodologies. iCardiac's analysis service provides drug developers with m...used as secondary end-points by the regulators, and deliver a more accurate assessment of the cardiac safety profile of drugs in development. iCardiac's COMPAS te...

Amicus Therapeutics Announces Second Quarter 2009 Financial Results

...-3 as measured in kidney biopsies using histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including glomerular filtration rate (GFR) and 24-hour urine protein). Additionally, the FDA and Amicus reached agreement on...

Oncothyreon appoints Diana Hausman as Vice President of Clinical Development

... These forward-looking statements represent Oncothyreon's intentions, plans, expectations and beliefs and are based on its management's experience and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances. Forward-looking statements invol...

Oncothyreon announces presentation of long-term Stimuvax data at World Conference on Lung Cancer

... These forward-looking statements represent Oncothyreon's intentions, plans, expectations and beliefs and are based on its management's experience and assessment of historical and future trends and the application of key assumptions relating to future events and circumstances. Forward-looking statements invol...

Anadys Pharmaceuticals Receives FDA Clearance of Phase II Protocol to Study ANA598 in Combination With Interferon-Alpha and Ribavirin in HCV Patients

...n rats and 39 weeks duration in monkeys). At the 13-week interim, the toxicology profile of ANA598 in both species was very favorable. A preliminary assessment of the results from the 26-week study in rats indicates a similar profile to that seen in rats at 13 weeks, in which the only adverse finding was a ma...

Anadys Pharmaceuticals Reports Second Quarter 2009 Financial Results and Program Highlights

...im, the toxicology profile of ANA598 in both species was very favorable. While 39-week data from the monkey study is not yet available, a preliminary assessment of the results from the 26-week study in rats indicates a similar profile to that seen in rats at 13 weeks, in which the only adverse finding was a ma...

Mylan Reports Adjusted Diluted EPS of $0.32 for the Quarter Ended June 30, 2009

...itions as well as certain other non-recurring and non-cash expenses and revenue in order to supplement investors' and other readers' understanding and assessment of the company's financial performance because the company's management uses these measures internally for forecasting, budgeting and measuring its op...

Atherotech Taps Canyons Medical Center Director, Lipidologist as Chief Medical Officer

...ers. "I'm excited to join Atherotech with their dedication to lipid assessment and risk management," said Cobble. "Too many cardiovascular events continue...s, including C-Reactive Protein (hsCRP), ApoE genotype and NT-proBNP for assessment of patients at intermediate to high risk of cardiometabolic diseases. Ather...

Elagolix Successful in Six Month Lilac Petal Study; Safety and Efficacy Confirmed in Patients With Endometriosis

...t women had minimal endometriosis pain symptoms at month six (mean scores of approximately 0.5 for both doses and both of the 0-3 scales). The overall assessment of benefit using the Patient Global Impression of Change (PGIC) revealed that 80% of elagolix 150 mg subjects and 79% of elagolix 250 mg subjects were...

Sanofi-aventis Announces Second Quarter 2009 Results

...ere was no observable difference in terms of serious adverse events, including cancer. On July 23 2009, The CHMP has re-confirmed their initial assessment of Lantus ((R)) , based on an in-depth review of existing evidence and of the recent publications of registry analyses in Diabetologia . All four reg...