Navigation Links
Biopure Reports on Meeting with the FDA
Date:9/6/2007

CAMBRIDGE, Mass., Sept. 6 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that it had recently met with the FDA to discuss the compassionate use protocol submitted by the company in July. At the FDA's suggestion, the company intends to submit a protocol for a Phase 2 randomized trial for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia, including alloantibody anemia but excluding sickle cell anemia. Hemopure has been used previously, on a compassionate use basis, to treat patients with these conditions.

The proposed patient group was included in the compassionate use protocol previously proposed to the FDA. A study protocol for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia would be in place of that compassionate use protocol. Biopure may continue to work with the FDA on compassionate use cases through single patient INDs that are requested from treating physicians.

Autoimmune hemolytic anemia is a group of disorders characterized by a malfunction of the immune system that produces antibodies to the patient's red blood cells attacking them as if they were substances foreign to the body. This group of disorders is uncommon, can occur at any age and affects women more often than men.

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. Biopure has applied in the United Kingdom for regulatory approval o
'/>"/>

SOURCE Biopure Corporation
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Corgenix Reports New Clinical Data Correlating AtherOx Technology With Vascular Disease
2. Cobalis Reports Phase III Trial Results for PreHistin in Seasonal Allergic Rhinitis
3. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
4. Cytos Biotechnology Reports Results from Phase IIa Study with CYT003-QbG10 in Patients Suffering from Atopic Dermatitis
5. Cytokinetics Reports Additional Clinical Trials Data for Ispinesib
6. The European Myeloma Platform Reports New Survival data for Revlimid Presented at the International Myeloma Workshop in Greece
7. Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection
8. Speedel Reports Successful SPP635 Phase IIa Trial in Hypertension
9. Columbia Laboratories Reports Positive Results from Multi-dose Pharmacokinetic Study of Vaginally-administered Lidocaine
10. CytRx Reports Promising Data from Its Open-Label Extension Clinical Trial of Arimoclomol in ALS
11. Affymax Reports Phase 2 Clinical Dose Ranging Results of Once-Per-Month Hematide for the Treatment of Anemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/27/2015)... SAN DIEGO , March 27, 2015 /PRNewswire/ ... informatics company, today announced new data showing that, ... Mantis TM technology provided highly equivalent interpretations ... cause disease, and did so in a fraction ... pave the way for more comprehensive genetic analysis ...
(Date:3/27/2015)... Mass. , March 27, 2015 ... platform for drug discovery and development services which ... for the pharmaceutical industry, announced financial results for ... Timothy C.  Tyson, Chairman of XRpro Sciences ... to successfully transition from development stage to commercial ...
(Date:3/27/2015)... DALLAS , March 27, 2015 ... Market by Product (Diagnostic Catheter (Conventional, Advanced, Ultrasound), Ablation ... ICE, X-ray)) & Indication (AF, VT, WPW) - Global ... Market is expected to reach around ~$4.73 Billion by ... forecast period 2014 to 2019. Browse ...
Breaking Medicine Technology:New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 2New Data at ACMG Shows Cypher's Software Can Automate Interpretation of Genetic Variants to Advance Non-invasive Prenatal Testing 3XRpro Sciences Announces Fiscal 2014 Financial Results 2XRpro Sciences Announces Fiscal 2014 Financial Results 3XRpro Sciences Announces Fiscal 2014 Financial Results 4Electrophysiology (EP) Market Worth $4.73 Billion by 2019 2Electrophysiology (EP) Market Worth $4.73 Billion by 2019 3Electrophysiology (EP) Market Worth $4.73 Billion by 2019 4
...  One thousand women in Europe ... identified as a result of the   Sectra OneScreen   ... the risk of painful fractures because inexpensive and effective treatment ... throughout Europe are using this service to screen for osteoporosis, ...
... 2012   ULURU Inc. (NYSE AMEX: ULU),announced today ... been issued by the Therapeutic Goods Administration approving the ... the approval in Australia, Kerry P. Gray, President and ... in the worldwide commercialization of Altrazeal®.  Strategically this is ...
Cached Medicine Technology:1,000th Woman Identified Using Sectra's Analysis Method - European Mammography Clinics Mark Milestone in the Struggle Against Osteoporosis 21,000th Woman Identified Using Sectra's Analysis Method - European Mammography Clinics Mark Milestone in the Struggle Against Osteoporosis 3ULURU Inc. Announces Approval to Market Altrazeal® in Australia 2ULURU Inc. Announces Approval to Market Altrazeal® in Australia 3
(Date:3/27/2015)... While deep learning was the topic of many ... , the CEO of one start-up spoke passionately about using ... well beyond the generally-agreed ceiling of 120 years. , Insilico ... of 12 companies recognized as the hottest GPU-powered startups in ... GTC Emerging Companies Summit have business models focused on ...
(Date:3/27/2015)... KING OF PRUSSIA, PA and LONDON, UK (PRWEB) March ... and current President of DrugDev SiteStart Melissa (Liss) Easy ... Under 40. , The 40 Under 40 list ... of age for their professional accomplishments and community involvement. ... and profiled in a special supplement of the Philadelphia ...
(Date:3/27/2015)... The report “CountryFocus: Healthcare, Regulatory and ... information on and analysis of the healthcare, regulatory and ... US in 2013 amounted to 316.1 million, having grown ... from 2008. The country’s increasingly elderly population and corresponding ... to boost the growth of the pharmaceutical market, which ...
(Date:3/27/2015)... Milpitas, CA (PRWEB) March 27, 2015 ... company, today announced it has launched the SM1120 MEMS ... catheter market. The microsensor profile at only 220um ... enabling maneuverability to reach challenging locations. With industry ... per hour, the SM1120 provides a broad operating pressure ...
(Date:3/27/2015)... When struck with the aftermath of a trucking ... begin. The latest eBook released by Dax Jones ... victims a clear and concise process for obtaining the ... injury claim is seen through to successful completion. , ... should be taken immediately following the trucking incident. From ...
Breaking Medicine News(10 mins):Health News:InSilico Medicine, Inc. Stands Out from High Tech Startups at 2015 GPU Conference 2Health News:InSilico Medicine, Inc. Stands Out from High Tech Startups at 2015 GPU Conference 3Health News:DrugDev Founder Melissa Easy is 2015 Philadelphia Business Journal 40 Under 40 Honoree 2Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 2Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 3Health News:US Pharmaceutical Market worth $548.4 billion by 2020 Says a New Report Available at RnRMarketResearch.com 4Health News:SMI Launches Catheter Mountable Pressure Sensor 2Health News:Dax Jones Updated eBook on Trucking Accidents Offers Helpful Information to Crash Victims 2
... 2010 Neuralstem, Inc. (NYSE Amex: CUR) announced ... rat brains affected by stroke and differentiated predominantly ... in some motor skill and strength measurements. The ... Stem Cells To Reverse Motor Deficits in Chronic ...
... Families from rural Mexico who receive health care from centralized ... percent less in out-of-pocket expenses and utilize preventive services more ... states, according to a study by researchers at the UCLA ... published in the September issue of the Journal of ...
... By Serena Gordon HealthDay Reporter , MONDAY, Sept. 13 ... rather than the hospital results in higher quality-of-life scores at the ... as well. , A study published online Sept. 13 in ... people who died in intensive care units (ICU) or other areas ...
... small, seemingly benign holes in a child,s heart may ... could be lurking out of sight. These are the ... at Nationwide Children,s Hospital and the Ohio State University ... form of congenital heart disease, ventricular septal defect. The ...
... CLEMENTE, Calif. (September 13, 2010) USGI Medical, ... updated multi-center results confirm durability of the company,s ... more in a variety of incisionless gastrointestinal (GI) ... of Surgery, Endolumenal) to repair dilated tissue after ...
... used to treat attention-deficit/hyperactivity disorder (ADHD) also provides ... that affect many childhood cancer survivors, according to ... Research Hospital investigators. Researchers reported that one ... survivors scored better on tests of sustained attention ...
Cached Medicine News:Health News:Neuralstem stem cells survive and differentiate into neurons in rats with stroke 2Health News:Centralized health care more cost-effective, offers better access to preventive services 2Health News:Centralized health care more cost-effective, offers better access to preventive services 3Health News:Dying at Home Often Easier on Cancer Patients, Caregivers 2Health News:Dying at Home Often Easier on Cancer Patients, Caregivers 3Health News:Study identifies underlying dysfunction of seemingly non-critical heart condition 2Health News:USGI medical tissue anchors show durability beyond 1 year 2Health News:Childhood cancer survivors show sustained benefit from common ADHD medication 2Health News:Childhood cancer survivors show sustained benefit from common ADHD medication 3
... digital single plane C-arm angiography system is ... performance and an expansive range of diagnostic ... to ECG triggered. ... of the art dynamic Flat Detector technology, ...
... Meta-4 Computerized ENG utilizes a ... comprehensive nystagmus and ocular motor ... storage, data analysis and reanalysis ... data in the Meta-4 software ...
Stryker Leibinger offers a variety of different Titanium Implant Systems and special instrument sets, which enable our customers to treat a wide range of indication...
Stryker Leibinger offers a variety of different Titanium Implant Systems and special instrument sets, which enable our customers to treat a wide range of indication...
Medicine Products: