Navigation Links
Biopure Announces MHRA Meeting Update
Date:6/5/2008

CAMBRIDGE, Mass., June 5 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today an update regarding a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) addressing the Company's pending application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)].

The meeting, held on May 29, was attended by Biopure scientific representatives and the pharmaceutical and clinical assessors from the MHRA. The subject of the meeting was manufacturing and quality. The pharmaceutical assessor accepted Biopure's proposed strategies for answering pending questions and provided clarification. The company is confident that it can resolve all of these issues satisfactorily. No new issues were raised.

As previously reported, 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. Biopure submitted its application for the treatment of acutely anemic adult orthopedic surgery patients less than 80 years of age in July 2006, and the MHRA accepted it for review in September 2006. The MHRA issued its preliminary opinion, part of the normal review process, in December 2006. In Biopure's response to the preliminary opinion letter, submitted in November 2007, Biopure changed the indication to the treatment of acute anemia following orthopedic surgery blood loss when blood is not readily available or not an option. An issue in resolving the Commission's clinical comments could be that Biopure has not completed a clinical trial for anemia in patients where blood was not available or an option. Its relevant trials, on which the marketing app
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Biopure Gives Update on Malaysia Joint Venture Discussions
2. Biopure Announces Pricing of Equity Offering
3. Biopure Launches Updated Website
4. Biopure Announces 2008 First Quarter Financial Results
5. Biopure Completes U.K. Regulatory Agency Inspection
6. Biopure Appoints New Independent Auditor
7. Biopure Operations Compliant With U.K. Manufacturing Guidelines
8. Biopure Announces Date to Meet with UKs Medicines and Healthcare Products Agency
9. Biopure Appoints Dechra Exclusive U.S. Distributor of Oxyglobin
10. Biopure Announces 2008 Second Quarter Financial Results
11. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... RENU 28, the world's first and only skin ... purchase in Australia and New Zealand in mid-August . , ... The tour will make stops in Brisbane on September 16, ... Sydney on the 20th, and Melbourne on the 22nd. , ... and to educate people about the new product and business ...
(Date:9/15/2014)... Sept. 15, 2014   Global Science & ... scientific products and services for satellite and weather ... for Integrated Services (OASIS) from the General Services ... selected to provide the government best-value solutions for ... (SB) category in Pool 4. The OASIS SB ...
(Date:9/15/2014)... Sept. 15, 2014 EnGeneIC, Ltd. ... the treatment of cancer through the targeted delivery ... that, together with the Asbestos Disease Research Institute ... New South Wales (NSW) Premier,s Award for Excellence ... are the hospitals that will be involved in ...
(Date:9/15/2014)... have developed a technique for controlling the surface tension ... the door to a new generation of reconfigurable electronic ... the fact that the oxide "skin" of the metal ... as a surfactant, lowering the surface tension between the ... a liquid metal alloy of gallium and indium. In ...
Breaking Biology Technology:Global Wellness Company Hosts ASEA Australia Tour September 16-22 2Global Science & Technology, Inc. Awarded GSA OASIS Small Business Contract 2Global Science & Technology, Inc. Awarded GSA OASIS Small Business Contract 3EnGeneIC Named a Recipient of the Cancer Institute NSW Premier's Award for Excellence in Translational Cancer Research 2EnGeneIC Named a Recipient of the Cancer Institute NSW Premier's Award for Excellence in Translational Cancer Research 3Researchers control surface tension to manipulate liquid metals 2
... Sinovac Biotech Ltd. (Amex:,SVA), a leading provider ... today that the Annual General Meeting of ... postponed due the geographical,nature of its shareholders ... materials. The Company is currently working to ...
... LLC announced,today that two new managing directors have ... firm in July 2007 as Managing Director and,Associate ... portfolios of potential investments for Third,Security,s funds, and ... and develop their own intellectual property positions. Mr. ...
... Aug. 20 Advanced Cell,Technology, Inc. (OTC Bulletin ... conditions, it plans to privately offer up to ... timing of the,closing of the offering will be ... are expected to be used to fund working ...
Cached Biology Technology:Sinovac Announces Postponement of Annual General Meeting 2Third Security, LLC Hires Two New Managing Directors 2Advanced Cell Technology Announces Proposed Financing 2Advanced Cell Technology Announces Proposed Financing 3
(Date:9/15/2014)... West Africa, which has claimed more than 2000 lives, ... the molecular biology of the virus that could be ... to treat or prevent Ebola hemorrhagic fever. Now, a ... under the leadership of Dr Dan Engel, a virologist, ... obtained the crystal structure of a key protein involved ...
(Date:9/15/2014)... long and weighing as much as 170 tons, the blue ... far the heaviest living thing ever seen on Earth. So ... the tiniest fish larvae, which measure millimeters in length and ... , Not so fast, says L. Mahadevan, the Lola ... Evolutionary Biology, and of Physics. , Using simple hydrodynamics, ...
(Date:9/15/2014)... teeming with life it,s not what comes to mind ... time evidence of Doncaster,s 310-million-year-old past, including a fossilised shark ... , Some of the fossilised plants and creatures may even ... case, several horseshoe crabs and some previously unrecorded seed pods ... rocks that formed within the coal and shale deposits in ...
Breaking Biology News(10 mins):Protein secrets of Ebola virus 2The science behind swimming 2The science behind swimming 3'Jaws' lived in Doncaster 2
... change is already having a detectable impact on birds ... team publishing their findings to create the world,s first ... a continental scale. Published in the journal ... Royal Society for the Protection of Birds have shown ...
... climate change projected this century for Oregon,s Upper ... supplies, buildings, transportation systems, human health, forests, and ... by the University of Oregon,s Climate Leadership Initiative ... Policy. The authors say that extensive efforts ...
... DNA in the nucleus of each of our cells is converted ... serve as coding templates for the synthesis of proteins. Of the ... scant few are known: they inhibit the activity of genes or ... within cells. What the rest of them do within cells is ...
Cached Biology News:Climate change affecting Europe's birds now, say researchers 2Climate change affecting Europe's birds now, say researchers 3Eugene-Springfield face Upper Willamette climate threats 2Eugene-Springfield face Upper Willamette climate threats 3Eugene-Springfield face Upper Willamette climate threats 4CSHL researchers pinpoint structure-building role for 2 non-coding RNAs 2CSHL researchers pinpoint structure-building role for 2 non-coding RNAs 3