Navigation Links
Biopure Receives Comment Letter From U.K. Regulatory Body on Marketing Application for Hemopure(R)
Date:4/7/2008

CAMBRIDGE, Mass., April 7, 2008 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it has received a comment letter from the United Kingdom's Commission on Human Medicines addressing the company's application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)] pending with the Medicines and Healthcare products Regulatory Agency (MHRA).

The comment letter states that the Commission was "reassured" on a number of the questions raised in its initial comment letter, but indicated that both "major" and "other" pharmacological and clinical issues either were not yet resolved by the Company's submission made in November 2007 or were only resolved in part. In addition, the comment letter poses several new questions. The comment letter invites Biopure to discuss the issues with the MHRA team of three medical, statistical and pharmaceutical reviewers.

The Commission has not advised the company to withdraw its application. The company has been advised that such a request would be the customary means of indicating futility or rejection of an application.

"We intend to proceed by meeting and consulting with the UK regulatory review team, as suggested, as soon as possible, for clarification of their requirements," said Biopure Chairman and CEO Zafiris G. Zafirelis. "Based on preliminary advice, we are encouraged to proceed with the application."

Biopure intends to announce the date of its meeting with the MHRA reviewers when it is set, as well as the outcome of the meeting and an anticipated timeline.

According to the Commission, there are no major preclinical issues. The major remaining issues relate to quality, clinical efficacy, safety and the reliability
'/>"/>

SOURCE Biopure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Biopure Announces 2007 Fourth Quarter and Year-End Financial Results
2. Four Abstracts by Biopure and Collaborating Scientists Accepted for Annual Meeting of American Society for Clinical Pharmacology and Therapeutics
3. Biopure Announces Closing of $14.9 Million Financing
4. Biopures Stock Symbol Reverts to BPUR
5. Biopure Announces Reverse Stock Split
6. iCAD Receives FDA Approval for Its SecondLook Digital for Use With Fujis Digital Mammography System
7. FORSTEO(R) Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis
8. Portrait(R) Plasma Receives Clearance from the FDA to Treat Acne Scars
9. CryoCor Reports Going Concern Statement and Receives Notification From Nasdaq Relating to Minimum Stockholders Equity
10. Western Reserve Heart Care Receives ICANL Nuclear Medicine Accreditation
11. AIDS Activist Gregg Gonsalves Receives $100,000 Leadership Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... Relias Learning, the leader in SaaS-based training and ... announced the latest release of its flagship LMS with ... , “Supporting the Tin Can API ensures our ... learning capabilities and the ability to leverage the latest ... Jim Triandiflou, CEO of Relias Learning. “To provide our ...
(Date:8/21/2014)... ERT, a leading global ... efficacy endpoint data collection, today opened registration ... Maximizing Product Value with Optimized Endpoints. ... biopharmaceutical developers to network with leading researchers ... developing, implementing, and justifying effective strategies for ...
(Date:8/21/2014)... elicited by T-type calcium channels in the thalamic ... of calcium. These channels enable thalamic reticular nucleus ... to enter a hyper-excited state. , In order ... absence seizures, the researchers conducted an experiment to ... techniques to delete the T-type calcium channel CaV3.3. ...
(Date:8/21/2014)... we put on in the morning? Do we drive to ... we want to buy lunch? We make hundreds of different ... minimal impact, it is extremely important for our long-term personal ... People with ADHD often find this difficult, however. They are ... a prompt but smaller reward instead of making a choice ...
(Date:8/21/2014)... 21, 2014 The ... Vascular Devices Market by Angioplasty Balloon ... (IVUS, OCT), IVC Filter (Retrievable), Endovascular ... analyzes and studies the major market ... U.S. and Canada. , Browse 108 ...
Breaking Medicine News(10 mins):Health News:Relias Learning Announces Support for Tin Can API 2Health News:ERT Opens Registration for PROFICIENCY™ Regional Conference Series 2Health News:ERT Opens Registration for PROFICIENCY™ Regional Conference Series 3Health News:ADHD children make poor decisions due to less differentiated learning processes 2Health News:North American Interventional Cardiology and Peripheral Vascular Devices Market worth $5.9 Billion by 2018 - Research Report by MarketsandMarkets 2Health News:North American Interventional Cardiology and Peripheral Vascular Devices Market worth $5.9 Billion by 2018 - Research Report by MarketsandMarkets 3Health News:North American Interventional Cardiology and Peripheral Vascular Devices Market worth $5.9 Billion by 2018 - Research Report by MarketsandMarkets 4Health News:North American Interventional Cardiology and Peripheral Vascular Devices Market worth $5.9 Billion by 2018 - Research Report by MarketsandMarkets 5
... minister of Ireland has asked the health officials to review ... after an inquiry was probed in to the matter of ... killed by her mentally ill boyfriend Paul McCleery in March ... is a voluntary patient of mental health services provided by ...
... The case of an 11-year-old girl who is all set to ... shocked and frustrated health experts who maintain// that it is her ... whose identity is not being disclosed for legal reasons, is a ... pregnant after indulging in intercourse while on a drinking binge. The ...
... Madhya Pradesh has stated that more than 70 percent of ... of curriculum in schools//. ,The Madhya Pradesh Voluntary Health ... 10 to 19 years in 12 districts of the state. ... the awareness would help them remain healthy and not get ...
... a new study, oral and intravenous antiviral drug may ... ,Shingles, which is caused by varicella-zoster virus, is ... researchers at the University of Colorado and Health Sciences ... and three women with moderate to severe pain following ...
... been bitten by a bat and subsequently diagnosed with rabies has ... treatment is being offered, the chances of the boy recovering is ... student of Humble High School fell ill last week, unaware of ... this could happen, a bat had flown into his house while ...
... have been discovered by scientists at UCSF, Celera Genomics and ... risk// for early heart attack, or myocardial infarction (MI). ... a protein essential for early stages of clotting. When clotting ... heart attack. Knowing gene mutations that increase heart attack risk ...
Cached Medicine News:Health News:Health Experts Shocked As 11-year-old Girl To Be UK's Youngest Mother 2Health News:Girls In MP Want Sex Education In Schools: Health Survey 2Health News:Gene Variants Linked to Early Heart Attack Discovered 2Health News:Gene Variants Linked to Early Heart Attack Discovered 3Health News:Gene Variants Linked to Early Heart Attack Discovered 4
(Date:8/20/2014)... The National Association of Drug Diversion ... by the real-time, pseudoephedrine (PSE) blocking system in ... Exchange (NPLEx), automatically blocks unlawful pseudoephedrine sales and ... and make arrests. Data released by NPLEx shows ... blocked the sale of more than 7,481 boxes of ...
(Date:8/20/2014)... 2014  The National Association of Drug Diversion ... by the real-time, pseudoephedrine (PSE) blocking system in ... Exchange (NPLEx), automatically blocks unlawful pseudoephedrine sales and ... and make arrests. Data released by NPLEx shows ... blocked the sale of more than 32,890 boxes of ...
(Date:8/20/2014)... YORK , Aug. 20, 2014 ... new market research report is available ... Market for Hospital-Acquired Infection Control (Sterilization, ... http://www.reportlinker.com/p01618925/The-Market-for-Hospital-Acquired-Infection-Control-Sterilization-Disinfection-Testing-and-Treatment.html ... healthcare-associated infections (HAIs), demand has increased ...
Breaking Medicine Technology:Kansas's Stop-Sale System Achieves Significant Results In Battle Against Meth 2Michigan's Stop-Sale System Achieves Significant Results In Battle Against Meth 2The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 2The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 3The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 4The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 5The Market for Hospital-Acquired Infection Control (Sterilization, Disinfection, Testing and Treatment) 6
... helps provide protection to the exposed airway of ... lightweight making it ideal for active young children ... of heat and moisture recovery, it ensures patient ... and filters have ISO standard tapered ends to ...
For use with: , pulmonary function testing , nebulizer compressors , humidifiers , concentrators , proximal pressure lines ...
Indications For Usage: , ,For use during pulmonary lung function testing...
... The Portex® Thermovent® T helps provide protection ... It is small and extremely lightweight making it ... adults. With a high rate of heat and ... secretion retention., ,All HMEs and filters have ...
Medicine Products: