Navigation Links
U.S. Navy Requested Operations Trial on FDA Hold
Date:12/30/2008

CAMBRIDGE, Mass., Dec. 30 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center ("NMRC") by letter that it may not initiate a clinical trial of Biopure's product Hemopure [hemoglobin glutamer - 250 (bovine)], under a proposed protocol submitted to the FDA on November 21, 2008. As previously announced, the Navy had filed a protocol for a proposed trial for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions ("Op RESUS").

While the FDA letter acknowledges that the proposed trial addresses some of FDA's concerns previously communicated, it gives three regulatory bases for the hold: safety of subjects, protocol design deficient to meet its stated objectives; and the content of the investigator brochure (a summary of information for those carrying out the trial) and related items. Concerning safety, the FDA hold letter refers to the risk of exacerbation of bleeding resulting from product infusion and the "adverse event profile of [Hemopure]." However, the letter refers in particular to the results of three previous trauma trials with adverse mortality rates, none of which was a Hemopure trial and one of which, according to the FDA, did not involve a hemoglobin based oxygen carrier. According to the FDA, based on these trials with other products, it cannot presently approve IND protocols with agents that may raise blood pressure in acute hemorrhagic shock.

The letter requests a "Clinical Hold Complete Response." The Company does not know how the NMRC will proceed.

Biopure Corporation

Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics that are intravenously administered to d
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. $3 Million Requested by UNFPA to Help Women and Girls Displaced by Myanmar Cyclone
2. Danialle Karmanos Work It Out Names Tracey Secco as Director of Operations
3. PRA International Expands Operations in Mexico
4. DNA2.0 Expands European Presence By Opening UK Office: Experienced Life Sciences Executive, Dr. Michael Dyson, to Lead European Operations
5. Duane Reade Holdings, Inc. Further Strengthens Management Team With Addition of Frank Scorpiniti, SVP, Pharmacy Operations
6. Operations engineering for more efficient operating rooms
7. Frost & Sullivan Lauds StatCom for Its Hospital Operations System
8. Warriors Unite: Mike Ditka & the Gridiron Greats Form Partnership to Assist Retired NFL Players & U.S. Military Special Operations Personnel
9. Jonathan Jacobson Appointed General Manager, Global Business Strategies & Operations, Menicon Co., Ltd.
10. AmeriCares Launches India Operations
11. Accumetrics, Inc. Appoints William Dippel as Executive Vice President of Operations and R&D
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2015)... (PRWEB) May 24, 2015 EnviroLeather™ ... launches “InkGard™ Plus” – a classic, rugged leather ... polymer allowing difficult stains, including ink, to be ... different colors suitable for corporate, healthcare, hospitality and ... line with EnviroLeather’s goal of developing products that ...
(Date:5/24/2015)... ProPin is a set of self-animating 3D pin markers ... to pin point locations on a map, to indicate prices or ... users to choose from 30 simplistic presets with geometric design elements ... editors can easily manipulate ProPin presets as a whole. Pixel ... , Using ProPin is easy, simply drag a preset into the ...
(Date:5/24/2015)... Scottsdale, Arizona (PRWEB) May 24, 2015 ... hired former Millennial Media strategy executive Jay Krihak ... as Medicx looks to ramp up its expertise ... services of the Pharmaceutical and Health sectors. , ... ad tech executive. Most recently, Krihak led sales ...
(Date:5/24/2015)... A report out just last ... best option for avoiding cardiovascular disease is exercise and ... the single most powerful predictor of death and survival, ... and family history of premature death -- a finding ... lung fitness. , The Importance of Cardiovascular Screening , ...
(Date:5/23/2015)... On May 13, Nithyananda Yoga Foundation ... yogic power learned through meditation and initiation at Special ... India. , Yogamaatha, a nine-year-old girl from North Carolina, ... professionals attending the 2015 Business Advocacy Summit at Capitol ... , In a demonstration that lasted three hours, ...
Breaking Medicine News(10 mins):Health News:EnviroLeather By LDI Launches "InkGard Plus" - Stain Resistant Faux Leather 2Health News:Developers at Pixel Film Studios Release ProPin for Final Cut Pro X. 2Health News:Medicx Media Solutions Expands Executive Team 2Health News:Recent Mayo Clinic Studies Help to Highlight the Value of Cardio Testing 2Health News:Recent Mayo Clinic Studies Help to Highlight the Value of Cardio Testing 3Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 2Health News:Nine-Year-Old Reads Blindfolded at Business Advocacy Summit 3
... , Linton Whitaker, M.D., ... Linton Whitaker, M.D., a craniofacial surgeon at The Children,s ... awarded the prestigious Paul Tessier Medal during the annual meeting ... , The Paul Tessier Medal is the highest honor awarded ...
... , , ... Holding Corp. (Nasdaq: ADAT ), a worldwide provider ... announced that it has completed its previously announced "registered direct" ... proceeds of $3.4 million. , At closing, Authentidate issued ...
... , , ... Services,Holdings Limited (NYSE: CCM ) ("CMS" or "the ... centers in China in terms of,revenues and the total number ... public offering of 12,000,000 American Depositary Shares,("ADSs"), each representing three ...
... , , , PITTSBURGH, Dec. 11 UPMC ... offer award-winning brain fitness software from Posit Science®, at no cost, ... brain training program is a new part of the UPMC Health ... , The brain fitness software, known as the Insight(TM) Brain ...
... risk factors and treatment effects are helping clinicians ... most likely to benefit from close monitoring, lifestyle ... in the December 15/22, 2009, Prevention and Outcomes ... American College of Cardiology aim to disentangle ...
... ... President Obama and Congressional Leadership , ... Washington, D.C. (Vocus) December 11, 2009 -- The Community Oncology Alliance ... their practices if critical Medicare reimbursement fixes for treating cancer patients are not made ...
Cached Medicine News:Health News:Children's Hospital Surgeon Receives Prestigious Paul Tessier Medal 2Health News:Authentidate Holding Corp. Completes Capital Raise 2Health News:Authentidate Holding Corp. Completes Capital Raise 3Health News:Concord Medical Services Holdings Limited Announces Pricing of Initial Public Offering on the New York Stock Exchange 2Health News:Concord Medical Services Holdings Limited Announces Pricing of Initial Public Offering on the New York Stock Exchange 3Health News:UPMC Health Plan Offers Brain Fitness Software to Improve Health 2Health News:UPMC Health Plan Offers Brain Fitness Software to Improve Health 3Health News:New research identifies modifiable risk factors for heart disease 2Health News:New research identifies modifiable risk factors for heart disease 3Health News:New research identifies modifiable risk factors for heart disease 4Health News:New research identifies modifiable risk factors for heart disease 5Health News:New research identifies modifiable risk factors for heart disease 6Health News:National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short In Addressing Cancer Care Crisis 2Health News:National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short In Addressing Cancer Care Crisis 3Health News:National Oncologist Group Warns: Current Health Care Reform Legislation Woefully Short In Addressing Cancer Care Crisis 4
(Date:5/22/2015)... 2015   InspireMD, Inc. (NYSE MKT: NSPR) ("InspireMD" ... ("EPS"), today announced that its CGuard TM Embolic Prevention ... Prof. Piotr Musialek , at the EuroPCR ... . PARADIGM, an investigator-initiated P rospective ... roti D revascularization I n symptomatic and increased-risk ...
(Date:5/22/2015)... May 22, 2015 Today, Rhodes Pharmaceuticals ... system stimulant indicated for the treatment of Attention-Deficit/Hyperactivity ... Summer 2015. The announcement comes ... from the U.S. Food and Drug Administration (FDA). ... formulation of methylphenidate capsule with an onset of ...
(Date:5/22/2015)... May 22, 2015 Richmond ... research unit with a worldwide reputation for excellence ... frequent publications in peer reviewed medical journals. Its ... and regulators in discussions about rules for transparency ...      (Logo: http://photos.prnewswire.com/prnh/20150522/745125) , Clinical research ...
Breaking Medicine Technology:InspireMD's CGuardTM Highlighted at Clinical Presentation at EuroPCR 2015 Conference 2InspireMD's CGuardTM Highlighted at Clinical Presentation at EuroPCR 2015 Conference 3InspireMD's CGuardTM Highlighted at Clinical Presentation at EuroPCR 2015 Conference 4Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD 2Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD 3Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD 4Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD 5Rhodes Pharmaceuticals Announces Launch of New, Once-Daily Treatment for ADHD 6
... is a fully automated, user-friendly system ... labor resources and improve patient care. ... and immunoturbidimetric testing capabilities with a ... assays. It's also a powerful, intuitive ...
... proteins produced with recombinant technology, that have been ... capable of detecting the different types of T.cruzi ... with amino acid sequences repeated in tandem. SAPA ... phase of the infection, it reacts with 93% ...
Inquire...
... Medtronic Subcutaneous Lead System Model ... with the use of the ... Improved SQ design and implant ... fast and easy procedure, and ...
Medicine Products: