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:9/1/2014)... 01, 2014 Building on the success ... American Sleep and Breathing Academy (ASBA) has officially ... for Healthcare Professionals. The event will be taking place ... 10th and 11th. This years’ event promises to be ... ASBA. , In recent years, Pro Player ...
(Date:9/1/2014)... Steven Reinberg HealthDay Reporter ... a head-to-head comparison, an experimental drug was more effective ... heart failure patients. According to the study authors, ... benefit of the new drug, dubbed LCZ696. ... standard medication, enalapril (Vasotec), either died or were hospitalized ...
(Date:9/1/2014)... An operating theatre or operating room is ... operations. An operating room comprises a myriad of specially-designed ... lights, imaging displays as well as integration systems for ... Research, a U.S.-based market research firm, the operating room ... by 2019. , According to this report, the ...
(Date:9/1/2014)... Spain Monday 1 September 2014: Daily fruit consumption ... to 40%, according to research presented at ESC Congress ... findings from the seven year follow-up study of nearly ... that the more fruit people ate, the more their ... including ischaemic heart disease (IHD) and stroke, is the ...
(Date:9/1/2014)... September 01, 2014 Bioinformatics refers ... and analyze biological and genetic data. A major ... of developing software tools to generate and process ... confused with biological computation. While bioinformatics simply makes ... biology can its related concepts, biological computation refers ...
Breaking Medicine News(10 mins):Health News:Pro Player Health Alliance Confirms Big Name Speakers at 2015 American Sleep and Breathing Academy Conference 2Health News:Pro Player Health Alliance Confirms Big Name Speakers at 2015 American Sleep and Breathing Academy Conference 3Health News:Pro Player Health Alliance Confirms Big Name Speakers at 2015 American Sleep and Breathing Academy Conference 4Health News:Drug Gives 'New Hope' Against Heart Failure, Expert Says 2Health News:Drug Gives 'New Hope' Against Heart Failure, Expert Says 3Health News:Operating Room Equipment Market Study 2019 by Transparency Market Research 2Health News:Operating Room Equipment Market Study 2019 by Transparency Market Research 3Health News:Fruit consumption cuts CVD risk by up to 40 percent 2Health News:Fruit consumption cuts CVD risk by up to 40 percent 3Health News:Bioinformatics Market: A fusion of Computers and Biological Data 2Health News:Bioinformatics Market: A fusion of Computers and Biological Data 3Health News:Bioinformatics Market: A fusion of Computers and Biological Data 4
... Hopkins Kimmel Cancer Center has come up with a remarkable ... that are helpful //to overcome impotence have added benefits. Sildenafil ... increasing the production of a chemical messenger seem to ... unmasked, will be recognized and ambushed by that ...
... biodegradable and may be poisoning oceans, fear British scientists.// ... the ubiquitous carrier bags - ends up in the ... of Plymouth is leading research into what happens when ... reported the online edition of BBC News. , ...
... Hospital diabetes transplant unit is among the first in Australia ... //The first big target for embryonic stem cell research will ... NSW predicting major progress within four years. ,A ... that overturns the ban on therapeutic cloning, which had paved ...
... described as remarkable findings that show some teenagers fear not ... can be termed significant, as choices in contraception are made ... adolescents, almost half expressed fears of not getting pregnant. ... White says that the assumption that teenagers do not want ...
... In Africa, malaria has rendered half a billion people ... is also grappling //with the largest number of HIV ... latest UN communiqué reported that 2 million people succumbed ... of Washington researchers have made a valid point in ...
... have a healthier diet and lifestyle than those who ... Lindsay Reaves of the University of Minnesota School of ... health behaviour of over 2,500 US high school seniors, ... study, which appeared in the December journal of the ...
Cached Medicine News:Health News:Impotency Drugs Help to Unmask Cancer Cells 2Health News:The Deadly Duo – Why Malaria and HIV Coexist in Afric 2
(Date:8/29/2014)... , Aug. 29, 2014 Diseases largely eradicated ... generation ago are returning. Measles was declared eliminated in ... 2014 as of August 15—the highest incidence in 20 ... health department declared whooping cough a problem of ... getting sick and dying from these preventable diseases—in part ...
(Date:8/29/2014)... 2014 /PRNewswire-iReach/ -- ChemImage will present a workshop focused ... Zealand Forensic Science Society,s 22 nd International ... Adelaide, Australia .  Forensic Scientists will be ... hyperspectral imaging can bring to examination procedures. ... of Product Development at ChemImage, will host a ...
(Date:8/29/2014)... Aug. 29, 2014  In part four ... a hospital pharmacy as a strategic asset, Mary ... leader for Cardinal Health,s Innovation Delivery Solutions business, discusses ... benefit both hospitals and patients. "Every hospital ... part of their job in a value-based healthcare world," ...
Breaking Medicine Technology:Vaccines at the Crossroads: Outbreaks On the Rise Across America 2Vaccines at the Crossroads: Outbreaks On the Rise Across America 3ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 2ChemImage to Discuss Hyperspectral Imaging for Forensic Investigation at the ANZFSS 22nd International Symposium on the Forensic Sciences 3Five Ways Hospital Pharmacies Can Fulfill Their Quality Care Mission 2Five Ways Hospital Pharmacies Can Fulfill Their Quality Care Mission 3Five Ways Hospital Pharmacies Can Fulfill Their Quality Care Mission 4
Plasma Control Level 1 - 1 ml...
The Mini Vidas is a compact version of the Vidas system with a built-in computer, keyboard and printer. Two independent sections each accept six tests and can process up to 12 samples simultaneously....
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: