Navigation Links
Biopure Completes U.K. Regulatory Agency Inspection
Date:3/19/2008

CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has completed its inspection of the company's Pennsylvania manufacturing facility. The inspection report contained no "Critical" and no "Major" deficiencies in compliance with good manufacturing practices. The MHRA report identified shortcomings characterized as "Other," with a request for a response detailing the company's corrective actions within 35 working days.

According to John Tomera, Director of Regulatory Affairs at Biopure, "We are pleased with the MHRA's inspection result, which attests to our efforts toward consistently maintaining quality standards. We anticipate being able readily to address all of the issues that were cited by the MHRA."

As previously announced, Biopure has pending with the MHRA a marketing authorization application to market Hemopure in the United Kingdom for acute anemia during elective orthopedic surgery where red blood cell transfusion is not available. The inspection is a routine part of the application procedure.

No inspection of the company's manufacturing facility in Massachusetts is scheduled at this time or expected to occur before the MHRA next communicates about the pending application.

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 Oxyglobin(R) [hemoglobin glutamer -- 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since 1998.

Contact: Tiana Gorham

Biopure Corporation

(617) 234-6826

IR@biopure.com


'/>"/>
SOURCE Biopure Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Biopure Announces 2008 First Quarter Financial Results
2. Biopure Launches Updated Website
3. Biopure Announces Pricing of Equity Offering
4. Biopure Gives Update on Malaysia Joint Venture Discussions
5. Environmental Operating Solutions Completes Initial Tranche of $2.5 Million Institutional Financing
6. AstraZeneca Completes Enrollment in Two Pivotal Phase III Studies of the Investigational Drug Vandetanib (ZACTIMA(R)) in Non-Small Cell Lung Cancer (NSCLC)
7. BrainCells Inc. Completes $30 Million Initial Closing of Series B Financing
8. PharmAthene Completes Pharmacokinetic Studies of Protexia(R); Program on Target for IND Filing in 2008
9. D-Pharm Completes Pre-IND Meeting With the FDA for Treatment of Acute Stroke With DP-b99
10. Plurality Completes R&D of its HAL-256 Multicore Processor
11. Cadence Pharmaceuticals Completes $49.3 Million Registered Direct Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/9/2017)... ... October 09, 2017 , ... At its national board ... Stubbs, a professor in Harvard University’s Departments of Physics and Astronomy, has been selected ... member of the winning team for the 2015 Breakthrough Prize in Fundamental physics for ...
(Date:10/7/2017)... (PRWEB) , ... October 06, ... ... years’ experience providing advanced instruments and applications consulting for microscopy and surface ... expertise in application consulting, Nanoscience Analytical offers a broad range of contract ...
(Date:10/6/2017)... ... October 06, 2017 , ... ... the healthcare and technology sector at their fourth annual Conference where founders, investors, ... inspiring speakers and the ELEVATE pitch competition showcasing early stage digital health and ...
(Date:10/5/2017)... , ... October 05, 2017 , ... Understanding the microbiome, ... frontiers in human health. Gut Love: You Are My Future, the newest exhibit on ... perspective as it explores the human condition through the lens of the gut microbiome. ...
Breaking Biology Technology:
(Date:4/11/2017)... , April 11, 2017 No two ... researchers at the New York University Tandon School ... Engineering have found that partial similarities between prints ... used in mobile phones and other electronic devices ... The vulnerability lies in the fact that ...
(Date:4/5/2017)... , April 4, 2017 KEY FINDINGS ... to expand at a CAGR of 25.76% during the ... is the primary factor for the growth of the ... https://www.reportbuyer.com/product/4807905/ MARKET INSIGHTS The global stem ... technology, application, and geography. The stem cell market of ...
(Date:3/30/2017)... March 30, 2017 Trends, opportunities and forecast ... behavioral), by technology (fingerprint, AFIS, iris recognition, facial recognition, ... others), by end use industry (government and law enforcement, ... and banking, and others), and by region ( ... Asia Pacific , and the Rest ...
Breaking Biology News(10 mins):