Navigation Links
Biopure Announces Date to Meet with UK's Medicines and Healthcare Products Agency
Date:5/2/2008

CAMBRIDGE, Mass., May 2 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that a meeting with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) is scheduled for May 29, 2008 in the UK.

The purpose of the meeting is to clarify the issues outlined in a letter Biopure received in April 2008 from the United Kingdom's Commission on Human Medicines regarding the company's application for marketing authorization for Hemopure(R). The issues relate to quality, clinical efficacy, safety and the reliability of data monitoring and auditing of clinical trials. The letter stated 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.

As Biopure previously announced on April 11, 2008, the MHRA found the Company's Pennsylvania manufacturing facility to be in general compliance with the principles and guidelines of good manufacturing practices as identified in the Commission Directives.

Biopure Corporation

Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to deliver oxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. The company is developing Hemopure for other indications and is supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Biopure Operations Compliant With U.K. Manufacturing Guidelines
2. Biopure Appoints New Independent Auditor
3. Biopure Completes U.K. Regulatory Agency Inspection
4. Biopure Announces 2008 First Quarter Financial Results
5. Biopure Launches Updated Website
6. Biopure Announces Pricing of Equity Offering
7. Biopure Gives Update on Malaysia Joint Venture Discussions
8. Pulmo BioTech Announces Appointment of Chief Financial Officer
9. Pioneer(R) Surgical Technology Announces First Human Implants of its NuNec(TM) Cervical Arthroplasty Device
10. Solei Systems, Inc., Announces That the Company Is Now Publicly Traded
11. China Pharma Holdings, Inc. Announces First Quarter 2008 Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... ITRA Global, one of the largest organizations dedicated ... has further expanded its global reach with the affiliation ... Australia, reports Mylinda Vick, CCIM, Chairman of the ITRA ... ACORPP (Australian Corporate Property and Projects) , is a ... to a wide range of clients in the private ...
(Date:12/19/2014)... MA (PRWEB) December 19, 2014 Charm ... MRLAFMQ test for the Detection of Aflatoxin M1 in ... to receive independent third party validation. The peer reviewed ... Unit of the Institute for Agricultural and Fisheries Research ... Group. , Aflatoxin B1, the most toxic aflatoxin ...
(Date:12/19/2014)... , Dec. 19, 2014  Roche (SIX: RO, ROG; ... Technologies, Inc. (Bina), a privately held company based ... USA. Bina provides a big data platform for ... (NGS) data. Bina,s proprietary on-market Genomic Management Solution, ... researchers to perform fast and scalable analyses to ...
(Date:12/19/2014)... 2014 Research and Markets ( ... "Technology Innovations in Smart Fabrics (Technical Insights)" ... http://photos.prnewswire.com/prnh/20130307/600769 The Research ... a detailed assessment on technological advancements and market ... 1. The Smart Fabrics market is ...
Breaking Biology Technology:ITRA Global Continues International Expansion in Perth and Brisbane, Australia 2Charm Sciences Achieves Independent Validation of First 15 Minute Quantitative Screening Method for Aflatoxin M1 2Roche acquires Bina Technologies and enters the genomic informatics market 2Roche acquires Bina Technologies and enters the genomic informatics market 3Technology Innovations in Smart Fabrics (Technical Insights) 2
... WOODLANDS, Texas, June 17 Berlin Heart Inc. today,announced ... by the FDA,to support the ongoing Investigational Device Exemption ... Dr. Christopher Almond of,the Children,s Hospital of Boston, and ... Inc. will serve as Co-Principal,Investigators for the grant project ...
... N.C., June 17 /PRNewswire/ -- Campbell Alliance, the ... industry, today announced that it has launched a new practice ... at Campbell Alliance, the Medical Affairs practice enables the firm ... , , "Our firm has done work ...
... June 17 /PRNewswire-Asia-FirstCall/ -- China-Biotics, Inc.,(Nasdaq: ... firm,specializing in the manufacture, research, development, marketing and,distribution ... the Russell,3000(R) Index and Russell Global(R) Index when ... global equity indices on June,26, 2009, according to ...
Cached Biology Technology:Berlin Heart Inc. Receives FDA Orphan Product Development Grant 2Campbell Alliance Launches New Practice Area Focused on Medical Affairs 2China-Biotics, Inc. to Join Russell 3000 Index 2China-Biotics, Inc. to Join Russell 3000 Index 3
(Date:12/17/2014)... 2014  Automation is fundamentally transforming the travel ... at international borders. Over the past decade, ePassports, ... veteran travelers to self process through border control ... at an increasing number of airports, seaports, and ... According to Maxine Most , Principal at ...
(Date:12/11/2014)... Dec. 09, 2014 Research and Markets ... ( http://www.researchandmarkets.com/research/9ql3kr/biometrics_market ) has announced the ... 2015-2019" report to their offering. ... is the adoption of multimodal biometric systems. Multimodal ... an individual for verification and identification purposes. This ...
(Date:12/10/2014)... Dec. 8, 2014 You,ve been here before: you ... can,t remember your password, site key or the answer to ... first grade teacher? Today, Hoyos Labs ... app that will finally put an end to the frustration ... TM . 1U leverages a user,s smartphone to acquire ...
Breaking Biology News(10 mins):Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2Biometrics Market in India 2015-2019: Key Vendors are 3M Cogent, NEC, Safran and Suprema 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 2The Password is Finally Dead: Launch of 1U Mobile App Eliminates Need for All Usernames and Passwords 3
... professor of medicine at National Jewish Health, has ... lipids and related compounds that can inhibit inflammation ... by influenza and respiratory syncytial virus (RSV). Over ... several scientific papers describing a naturally occurring lipid ...
... bunch of inanimate chemical compounds, the nucleic and amino acids ... have put on quite a soap opera for biologists since ... A new study, a highlight in the March issue of ... In TV listings the series would be described this ...
... considered to be the principle vectors of West Nile virus ... summer. In addition, these mosquitoes may also serve as overwintering ... mosquito to egg, then larva, and then adult. To ... in mosquitoes in the field and in the lab, and ...
Cached Biology News:Does the villainous 'selfish' gene undermine genome's police? 2Does the villainous 'selfish' gene undermine genome's police? 3West Nile virus passes from female to eggs, but less so from larvae to adults 2
... is ideal for high-fidelity amplification of ... as cloning and mutagenesis. High ... enzyme preparation containing recombinant DNA polymerase ... Site5' exonuclease) activity. Platinum Anti-Pfx ...
... The EC105 power supply is a highly compact, ... A single adjustment knob and one hi-lo range ... 10 volt increments from 20 to 250 volts. ... from indicating output voltage to output current. For ...
... precision beveling of micropipette tips ... unique abrasive plate drive system ... control of the beveling process. ... rapidly and produces consistent tip ...
...
Biology Products: