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:5/4/2015)... 2015 Fast on the heels of ... Amounts, and Allison Folmar, JD, join over 150 speakers ... , On Sunday, May 24, the conference presents "I ... Are you interested in Ryan Hinds' recovery story? The ... war against autism was written by Marcia Hinds, ...
(Date:5/4/2015)... Sara Soulati, CEO of Global ... in Los Angeles associated with the field of Enhanced ... The Sara Soulati Health For Life Program (SSHFLP). , ... lifestyle modification and disease prevention program. A provisional ... S. Patents and Trademarks Office and is now under ...
(Date:5/3/2015)... May 03, 2015 Leading international program ... it will be awarding the 2015 Harris Wofford Global ... Selemawit Ghebrendrias, are the deserving recipients of the award ... service, Harris Llewellyn Wofford. The two recipients were chosen ... for global health. , CFHI is one of ...
(Date:5/3/2015)... CA (PRWEB) May 03, 2015 NuevaCare ... MnemeTherapy® at two upcoming area seminars. The first event ... PSA Annual Regional Stroke Conference to be held at ... offered on Wednesday, May 13 during the Dementia Conference ... , “These seminars offer an excellent opportunity to ...
(Date:5/2/2015)... NV (PRWEB) May 02, 2015 Ticket Down ... tickets for the long awaited event today, Saturday, May ... Diehard boxing fans will be able to secure tickets ... , The fight that boxing fans have wanted for more ... months ago. Floyd “Money” Mayweather will step inside the ring ...
Breaking Medicine News(10 mins):Health News:Perhaps the most important information families touched by autism will ever hear is available this month at international conference in Chicago 2Health News:Perhaps the most important information families touched by autism will ever hear is available this month at international conference in Chicago 3Health News:Perhaps the most important information families touched by autism will ever hear is available this month at international conference in Chicago 4Health News:CEO Sara Soulati Announces Patent-Pending Designation For The Sara Soulati Health For Life Program 2Health News:SF-based Global Health Non-Profit Awards Harris Wofford Global Service Fellowship 2Health News:SF-based Global Health Non-Profit Awards Harris Wofford Global Service Fellowship 3Health News:NuevaCare Introduces MnemeTherapy® Approach to Care for Elderly Patients with Alzheimer’s, Stroke and Other Types of Neurodegenerative Conditions 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 2Health News:Cheap Floyd Mayweather vs. Manny Pacquiao Tickets: Ticket Down Has Last Minute Tickets for Mayweather vs. Pacquiao at the MGM Grand Garden Arena in Las Vegas 3
... suggests that the presence of tumor cells in the circulating ... and neck may predict disease recurrence and reduced survival. An ... a worse outcome. Those are the early ... of CTCs by a team of researchers at The Ohio ...
... , TUESDAY, Dec. 21 (HealthDay News) -- Certain ... fat, according to an animal study that might one day ... tests on mice, a team at the Joslin Diabetes Center ... caused progenitor cells in subcutaneous (just beneath the skin) white ...
... with locally advanced head and neck cancers who successfully ... so without losing the ability to speak clearly and ... Institute. "This is good news," said Joseph K. ... Duke and the corresponding author of the study. "I ...
... robotic surgery for upper airway and digestive track malignant ... techniques based on patient function and survival, according to ... neck squamous cell carcinomas account for about 4 percent ... year. Currently the standard minimally invasive surgery for these ...
... HealthDay Reporter , MONDAY, Dec. 20 (HealthDay News) ... for strict heart rate control in patients with atrial ... strokes. More lenient management of the condition is ... guidelines from the American College of Cardiology and the ...
... , MONDAY, Dec. 20 (HealthDay News) -- ... swallow after undergoing combined chemotherapy and radiation treatment, but ... have found. The new study included patients who ... treated with chemoradiotherapy for advanced head and neck cancer. ...
Cached Medicine News:Health News:Tumor cells in blood may signal worse prognosis in head and neck cancer patients 2Health News:Factors linked to speech/swallowing problems after treatment for head and neck cancers 2Health News:Robotic surgery for head and neck cancer shows promise 2Health News:Guidelines Eased for Patients With Irregular Heartbeats 2Health News:Guidelines Eased for Patients With Irregular Heartbeats 3Health News:Speech, Swallowing Usually OK After Head & Neck Cancer Therapy 2
(Date:5/1/2015)... 2015  Legendary actor and director Danny Glover ... campaign designed to educate and encourage patients with neurologic ... Affect (PBA) and to speak with their physician. The ... the ability to cry and laugh on cue and ... by people living with PBA episodes. While ...
(Date:5/1/2015)... 2015  Misonix, Inc. (NASDAQ: MSON ), ... and markets innovative therapeutic ultrasonic products for spine ... laparoscopic surgery and other surgical applications, announced today ... third quarter fiscal year 2015 on Thursday, May ... call that same day, Thursday, May 7, 2015, ...
(Date:4/30/2015)... April 30, 2015 /PRNewswire/ - Pivotal Therapeutics Inc. ... with a focus on Omega-3 therapies for cardiovascular ... highlights and financial results for the fiscal year ... herein are in Canadian dollars unless otherwise stated. ... significant, with the right strategic partners and additional ...
Breaking Medicine Technology:Danny Glover Joins PBA Facts Campaign, to Educate and Build Awareness of Pseudobulbar Affect (PBA), a Little Known but Widespread Neurologic Condition 2Danny Glover Joins PBA Facts Campaign, to Educate and Build Awareness of Pseudobulbar Affect (PBA), a Little Known but Widespread Neurologic Condition 3Misonix, Inc. To Report Third Quarter Fiscal Year 2015 Financial Results On Thursday, May 7, 2015 2Pivotal Therapeutics Announces 2014 Financial Results 2Pivotal Therapeutics Announces 2014 Financial Results 3Pivotal Therapeutics Announces 2014 Financial Results 4Pivotal Therapeutics Announces 2014 Financial Results 5Pivotal Therapeutics Announces 2014 Financial Results 6
... HealthWarehouse.com, Inc. (OTC Bulletin Board: HEWA), a ... consummated two separate transactions to acquire all the online ... medications, diabetics supplies, and medical equipment, and merge with ... "The combination will bring together two companies committed ...
... and INGELHEIM, Germany, Feb. 15, 2011 Pfenex ... the Pfenex Expression Technology™ platform and Boehringer Ingelheim ... leader in biopharmaceutical contract development and manufacture, announced ... agreement. It provides Boehringer Ingelheim with non-exclusive access ...
Cached Medicine Technology:HealthWarehouse.com Acquires Online Division of Hocks Pharmacy 2Pfenex Inc. and Boehringer Ingelheim Announce Non-Exclusive Strategic Agreement for the Use of Pfenex Expression Technology™ 2Pfenex Inc. and Boehringer Ingelheim Announce Non-Exclusive Strategic Agreement for the Use of Pfenex Expression Technology™ 3