Navigation Links
Bayer Temporarily Suspends Global Trasylol(R) Marketing
Date:11/5/2007

LEVERKUSEN, Germany and WEST HAVEN, Conn., Nov. 5 /PRNewswire/ -- Following consultation with the German Federal Institute for Drugs and Medical Devices (BfArM), the U.S. Food and Drug Administration (FDA), Health Canada, and other health authorities, Bayer announced today that it has elected to temporarily suspend worldwide marketing of Trasylol(R) (aprotinin injection) until final results from the Canadian BART trial can be compiled, received and evaluated. The company took this global action following direction from the German BfArM and requests from the FDA and other regulators that Bayer temporarily suspend Trasylol marketing in their respective countries until final BART data were available. The BART study is an independent randomized, controlled trial being conducted in high-risk cardiac surgery patients.

Once the complete BART dataset is available, Bayer will work with health authorities to evaluate whether these data have any impact on the positive benefit-risk assessment for Trasylol. At that time the temporary marketing suspension will be reevaluated. Additionally, the U.S. FDA, Health Canada and other health authorities have indicated their interest in working with Bayer to create a program for use during the temporary suspension under which physicians in these markets might request and receive Trasylol for treatment of certain surgical patients with an established medical need. Bayer will work with the FDA, Health Canada, and any other authorities who wish to institute similar programs, to outline appropriate patient profiles and the specific details.

This action follows notification to Bayer and regulatory authorities that the BART Executive Committee had halted the trial after a planned periodic data analysis indicated reduced bleeding but also an increase in all-cause mortality (that almost reached conventional statistical significance for 30- day mortality) for patients in the aprotinin treatment arm compared to patients who recei
'/>"/>

SOURCE Bayer HealthCare
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. IVCC launches groundbreaking insecticide projects with Bayer and Syngenta
2. AUDIO from Medialink and Bayer: Simple, Focused Ways to Boost Womens Health
3. Bayer HealthCare Cleared to Acquire Citracal(R)
4. Genzyme and Bayer Schering Pharma AG, Germany to Present New Data on Alemtuzumab in Multiple Sclerosis at ECTRIMS
5. Bayer Foundation Grant Creates Graduate Engineering Fellowship at University of Houston
6. AUDIO from Medialink and Bayer: Is Your Pain Reliever Undermining Your Aspirin Therapy?
7. Corbett Selected to Host the Only Midwest Global Awards Judging Competition
8. Tata Consultancy Services to Support Roches Global Capacity Building Initiative
9. Creative Technology Services Enhances its Global Competitiveness with Additional Regulatory Certifications
10. Briefing on a new Web resource to address global drinking water crisis
11. MDS Pharma Services Wins Award for Management of Global Malaria Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... 30, 2014 The Buffet Restaurants ... Following a drop in industry revenue in 2009, the ... industry revenue has been negatively affected by low levels ... industry has presented itself in the form of increasing ... “buffet-style restaurants tend to use lower quality ingredients in ...
(Date:9/30/2014)... (PRWEB) September 30, 2014 Follow ... compounds, which are mixed with animal feed to increase ... and improve gut health and digestion. Amidst the rapidly ... and meat across the globe, the need for quality ... sectors is on the rise, thereby driving demand for ...
(Date:9/30/2014)... A recent study completed at the University of Eastern ... the risk of coronary heart disease. The sources of ... The findings were published in Arteriosclerosis, Thrombosis & ... Heart Association. , Recent studies have not found an ... risk of cardiovascular diseases. It seems that the mere ...
(Date:9/30/2014)... Amy Norton HealthDay Reporter ... Long-acting contraceptive devices should be the first choice of ... American Academy of Pediatrics state. Although most U.S. ... other forms of contraception -- intrauterine devices (IUDs) and ... the academy. And they should be the "first-line" ...
(Date:9/30/2014)... VA (PRWEB) September 30, 2014 Visit ... of Chestnut Hill and you will find a loving ... together, Amyotrophic Lateral Sclerosis. , Steve was ... or Lou Gehrig’s Disease – just before the couple’s ... primary caregiver. , A new video, “Care, Support ...
Breaking Medicine News(10 mins):Health News:Buffet Restaurants in the US Industry Market Research Report Now Available from IBISWorld 2Health News:Buffet Restaurants in the US Industry Market Research Report Now Available from IBISWorld 3Health News:Rising Consumption of Meat and Meat Products to Fuel Growth in the Global Feed Acidifiers Market, According to New Report by Global Industry Analysts, Inc. 2Health News:Rising Consumption of Meat and Meat Products to Fuel Growth in the Global Feed Acidifiers Market, According to New Report by Global Industry Analysts, Inc. 3Health News:Dietary polyunsaturated fatty acids linked to smaller risk of coronary heart disease 2Health News:Pediatricians Endorse IUDs, Implants for Teen Birth Control 2Health News:Pediatricians Endorse IUDs, Implants for Teen Birth Control 3Health News:Hospice Provides Care and Support to Patients and Family Caregivers with ALS 2
... - Roundtable to examine the crisis in science education, scientific research, ... ... Election -, NEW YORK, April 7, 2008 ... explored some of the most complex,science and human health issues facing the ...
... Okla., April 7, 2008 Edmond Medical Center and,ophthalmologists ... of,Edmond Regional Eye Associates, will once again participate in ... cataract surgeries,for those who cannot afford to pay., ... the physicians,office. If the patient qualifies for the cataract ...
... 7, 2008 Principals announced today a $3,billion ... claims with,chemical manufacturer W.R.Grace & Co. and related ... emerge from bankruptcy,with no further obligations for asbestos ... until the 1970,s., Terms of the agreement ...
... Schoolchildren,who required surgery as infants for congenital ... problems with inattention and hyperactivity, and,often require remedial ... for,academic and behavior problems, and our findings reinforce ... follow-up and neurodevelopmental,screening," said study leader Amanda J. ...
... Dry airways may not only play a central role ... fibrosis, but also in much more common acquired chronic ... cigarette smoke-induced chronic obstructive pulmonary disease (COPD). This is ... under the direction of Assistant Professor Dr. Marcus Mall ...
... Island Man Enjoy His Young Family,and Active Life, ... the World Trade Center on September 11, 2001, New ... the scene. Now,more than seven years later, O,Connor needs ... injuries suffered later in,the line of duty., At ...
Cached Medicine News:Health News:Charlie Rose Science Series Wraps Up With Episode on 'The Imperative and Promise of Science' 2Health News:Charlie Rose Science Series Wraps Up With Episode on 'The Imperative and Promise of Science' 3Health News:Edmond Medical Center to Provide Free Cataract Surgeries 2Health News:$3 Billion Asbestos Deal Reached by W.R.Grace Company to Pay Asbestos Victims 2Health News:For Children With Heart Disease, a Risk of Attention and Behavior Problems 2Health News:Asthma and smoker's lung: dry airways play a key role 2Health News:Asthma and smoker's lung: dry airways play a key role 3Health News:The SCOOTER Store Donates Power Scooter to Former NYPD Officer Who Responded to 9/11 2Health News:The SCOOTER Store Donates Power Scooter to Former NYPD Officer Who Responded to 9/11 3
(Date:9/30/2014)... Sept. 30, 2014  HealthLoop® released an app version ... in iOS 8 and allows people to share medical ... harnesses native iOS technologies to enhance the HealthLoop experience ... connection with their doctors between visits. ... data they collect is exciting," says HealthLoop founder Dr. ...
(Date:9/30/2014)... Sept. 30, 2014 BioStructures, LLC has ... Association of Tissue Banks (AATB), it was announced ... Officer. Accreditation follows an intensive nine-month ... trained AATB inspector.  It establishes that the level ... facility meets or exceeds the standards set by ...
(Date:9/30/2014)... VIEW, Calif. , Sept. 30, 2014 /PRNewswire/ ... tissue diagnostics market, Frost & Sullivan recognizes Ventana ... Roche Group, with the 2014 North American Frost ... to strict quality practices along with a focus ... Ventana a global leader in tissue-based cancer diagnostic ...
Breaking Medicine Technology:HealthLoop Integrates with Apple's HealthKit Enabling Patients to Share Health Data with Their Doctors Right from their iPhone 2Biostructures, LLC Earns AATB Accreditation 2Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 2Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 3Frost & Sullivan applauds the diversity of Ventana products and services for the cancer diagnostics market 4
... SAN RAMON, Calif., Nov. 29, 2011 Odyssey ... biologically-relevant pathways in human cells, announced today that ... a laser-based confocal imaging platform from GE Healthcare, ... Odyssey Thera applies a systems ...
... Nov. 29, 2011 A new study in The ... a novel mechanism that cancer cells may use to escape ... cells induce tumor cell resistance to cytotoxic T cells in ... Center in Tampa, Fla., shows that a specific type of ...
Cached Medicine Technology:Odyssey Thera is First to Install Next Generation High-Content Imaging Capability 2New Study Points to Novel Mechanism by Which Tumors Escape Recognition by the Immune System 2New Study Points to Novel Mechanism by Which Tumors Escape Recognition by the Immune System 3
Endoscopes are also available in fully autoclavable models in 1.8, 2.7, 4.0. 5.0 and 10.0 mm diameters. Manufactured with precise swiss lenses. Built-in temperature measuring device to exactly determ...
Endoscopes are also available in fully autoclavable models in 1.8, 2.7, 4.0. 5.0 and 10.0 mm diameters. Manufactured with precise swiss lenses. Built-in temperature measuring device to exactly determ...
Endoscopes are also available in fully autoclavable models in 1.8, 2.7, 4.0. 5.0 and 10.0 mm diameters. Manufactured with precise swiss lenses. Built-in temperature measuring device to exactly determ...
Kleinert-Kutz Single Skin Hook, Large...
Medicine Products: