Navigation Links
CV Therapeutics and Astellas Announce FDA Approval for Lexiscan(TM) (regadenoson) Injection
Date:4/10/2008

at CV Therapeutics has received approval for in just over two years," stated Louis G. Lange, M.D., Ph.D., chairman and chief executive officer of CV Therapeutics. "We are very excited to have Astellas -- the clear market leader in pharmacologic stress for MPI -- commercializing Lexiscan."

"We are extremely pleased that the FDA has approved Lexiscan, an exciting new option for diagnosing coronary artery disease in patients who cannot undergo an exercise stress test," said Yoshihiko Hatanaka, president and chief executive officer of Astellas Pharma US, Inc. "We are preparing to launch Lexiscan soon after this approval in order to provide clinicians with this important new option for patients who need pharmacologic stress agents for MPI studies."

Lexiscan Clinical Trials

In two identically designed Phase III clinical trials, Lexiscan met primary endpoints for scan agreement rates by showing with 95 percent confidence that MPI studies conducted with Lexiscan were similar to MPI studies conducted with Adenoscan(R) (adenosine injection).

Lexiscan was generally well-tolerated in both Phase III studies. The most common adverse events reported in patients who received Lexiscan were shortness of breath, headache, flushing, chest discomfort, dizziness and nausea.

About Lexiscan

Lexiscan is an A2A adenosine receptor agonist approved for use as a pharmacologic stress agent in radionuclide MPI studies in patients unable to undergo adequate exercise stress. Lexiscan was designed to produce coronary vasodilation and increase coronary blood flow by activation of the A2A adenosine receptor. Lexiscan is administered as a rapid bolus (approximately 10 seconds) with no dose adjustment required for body weight. Lexiscan should not be administered to patients with second- or third-degree AV block or sinus node dysfunction who do not have a functioning artificial pacemaker. Adenosine receptor agonists, including Lexiscan, induce arterial vasodilati
'/>"/>

SOURCE Astellas Pharma US, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. Stemline Therapeutics Raises $12.5 Million
2. Lorus Therapeutics Announces Exclusive Multinational License Agreement with Zoticon Bioventures for Virulizin(R)
3. Amsterdam Molecular Therapeutics Part of Next Biotech Index
4. Sirion Therapeutics Highlights Pivotal Trial Results of Durezol(TM) at the American Society of Cataract and Refractive Surgery Annual Symposium
5. Alba Therapeutics Announces Appointment of Bruce A. Peacock as its Chief Executive Officer
6. Amsterdam Molecular Therapeutics to Appoint George Morstyn to Supervisory Board
7. DiObex Announces Presentation of Scientific Poster at Annual Meeting of American Society for Clinical Pharmacology and Therapeutics
8. ImaRx Therapeutics Reports Business Update and Financial Results for Fourth Quarter and Full Year 2007
9. Mercury Therapeutics Patents Filed
10. Cell Therapeutics, Inc. Announces Filing of Form 10-K
11. Vicus Therapeutics Announces Participation at 15th International Molecular Medicine Tri-Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... 2014 Opertech Bio, Inc., a ... cost effective approach to sensory evaluation, today announced ... the U.S. Patent and Trademark Office, encompassing high-throughput ... , “Opertech’s taste evaluation technology called Microtiter Operant ... throughput system for rapid characterization of taste sensory ...
(Date:9/2/2014)... Md. , Sept. 2, 2014  Synthetic ... novel anti-infective biologic and drug candidates targeting specific ... today positive results from its final preclinical toxicology ... Administration (FDA) guidance, this bridging study was required ... candidate designed to prevent the devastating effects of ...
(Date:9/2/2014)... Massachusetts , September 2, 2014 ... to BioData,s research and lab management services  ... management service, is pleased to announce the appointment of ... Culot most recently served as VP Marketing and Business ... life science research and clinical applications. Previously, ...
(Date:9/1/2014)... 01, 2014 The Collaborative R&D ... report provides comprehensive understanding and unprecedented access to ... by the worlds leading life science companies. , ... of how and why companies enter collaborative R&D ... partner’s negotiated deals terms provides critical insight into ...
Breaking Biology Technology:Opertech Bio Receives U.S. Patent for High-Throughput Taste Evaluation Technology 2Synthetic Biologics to Initiate Clinical Trials of SYN-004 in 4Q 2014 to Prevent Potentially Deadly C. difficile Infections 2Synthetic Biologics to Initiate Clinical Trials of SYN-004 in 4Q 2014 to Prevent Potentially Deadly C. difficile Infections 3Synthetic Biologics to Initiate Clinical Trials of SYN-004 in 4Q 2014 to Prevent Potentially Deadly C. difficile Infections 4Synthetic Biologics to Initiate Clinical Trials of SYN-004 in 4Q 2014 to Prevent Potentially Deadly C. difficile Infections 5Louis Culot Appointed as BioData's CEO 2Collaborative R&D Terms & Agreements in Pharma, Biotech and Diagnostics Industry Analysis, Size, Share, Growth, Trends And Forecast Research Report by Researchmoz.us 2Collaborative R&D Terms & Agreements in Pharma, Biotech and Diagnostics Industry Analysis, Size, Share, Growth, Trends And Forecast Research Report by Researchmoz.us 3Collaborative R&D Terms & Agreements in Pharma, Biotech and Diagnostics Industry Analysis, Size, Share, Growth, Trends And Forecast Research Report by Researchmoz.us 4
... SAN DIEGO , May 19 Volcano ... both 510(k) clearance and CE Mark approval for its ... who have both single-vessel and multi-vessel disease. This next ... of integrated multi-modality consoles and stand-alone physiology systems as ...
... Hothead Technologies, Inc. and Sivix Logistics LLC ... fob and associated sensor monitoring module to its lineup ... upon the H.O.T.™ System, a patent-pending system that embeds ... athlete, firefighter, soldier, or other personnel and collects and ...
... /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. ("Oncolytics") (TSX:ONC, NASDAQ: ONCY ... Food and Drug Administration (FDA) for review, the Company ... in combination with FOLFIRI (Folinic Acid (leucovorin) + Fluorouracil ... mutant colorectal cancer (REO 022). The principal investigator is ...
Cached Biology Technology:Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire 2Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire 3Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire 4Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire 5Hothead Technologies Partners with Sivix Logistics to Add Customized Handheld Monitors and Autonomous Sensors to its Product Line 2Hothead Technologies Partners with Sivix Logistics to Add Customized Handheld Monitors and Autonomous Sensors to its Product Line 3Oncolytics Biotech(R) Inc. Announces Phase I Colorectal Cancer Study 2Oncolytics Biotech(R) Inc. Announces Phase I Colorectal Cancer Study 3Oncolytics Biotech(R) Inc. Announces Phase I Colorectal Cancer Study 4
(Date:9/2/2014)... Air pollution regulations over the last decade in Taiyuan, ... there, accounting for a greater than 50% reduction in ... 2001 and 2010, according to researchers at the Columbia ... School of Public Health, the Shanxi Medical University, the ... and Shanghai Fudan University School of Public Health. , ...
(Date:9/2/2014)... Some people take stress in stride; others are done ... identified the molecular mechanisms of this so-called stress gap ... finding that could lead researchers to better understand the ... , "Like people, each animal has unique experiences as ... these life experiences can alter the expression of genes, ...
(Date:9/1/2014)... wisdom has long held that corals whose ... are passive organisms that rely entirely on ... nutrients and oxygen. But now scientists at MIT ... Israel have found that they are far from ... turbulent patterns that greatly enhance their ability to ...
Breaking Biology News(10 mins):Clean air halves health costs in Chinese city 2Discovery hints at why stress is more devastating for some 2Discovery hints at why stress is more devastating for some 3Nature's tiny engineers 2Nature's tiny engineers 3
... Indiana University study found that strengthening inspiratory muscles by ... the amount of oxygen these same breathing muscles required ... muscles. Louise Turner, a researcher in the Department ... an endurance activity, such as running, swimming or cycling ...
... to all living things can make hibernating marmots hungry ... obesity and eating disorders, according to a new study ... appears in the current issue of the Journal ... at http://jeb.biologists.org/cgi/reprint/213/12/2031 . Professor Greg Florant discovered ...
... dish coating could overcome a major challenge to the ... of Michigan researchers. Under today,s regulations, current stem ... the cells have been grown on animal-based substances that ... components create issues with the FDA (the U.S. Food ...
Cached Biology News:Inspiratory muscle training and endurance sport performance 2Marmots can teach us about obesity 2New culture dish could advance human embryonic stem cell research 2
Kit for testing the ability of a compound to simulate lipolysis in cultured human adipocytes. Kit contains controls, buffers and reagents for detecting glycerol and non-esterified free fatty acids. A...
... The Experion Pro260 analysis kit for 10 ... to perform protein analysis with the Experion ... Pro260 microfluidic chips, 3 x 520 microliters ... microliters Pro260 ladder (10-260 kD), 400 microliters ...
Caliper offers a wide array of standard LabChip products designed to be used in combination with our AMS 90 and LabChip 3000 microfluidic platforms....
... Staccato Mini-Workstations provide fast and reliable ... proteomics and drug development laboratories. Staccato ... instrumentation to automate basic liquid handling ... are controlled with either Caliper's time ...
Biology Products: