Navigation Links
Vasogen Provides an Update on ACCLAIM-II Preparations
Date:12/17/2007

for ACCLAIM-II, the FDA has been reviewing Celacade in the context of their newly issued draft document entitled 'Guidance for Industry Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide' to assess whether this draft guidance is relevant to the Celacade technology. To date, the Celacade System has been regulated as a medical device with the Center for Devices and Radiological Health (CDRH) acting as lead reviewer with input from Center for Biologics Evaluation and Research (CBER). The FDA has recently informed the Company that they expect Celacade to remain regulated as a medical device; however, CBER may take the role of lead reviewer with CDRH providing input.

"We expect FDA clarification shortly and are looking forward to our formal agreement meeting with the agency. We are very pleased with the progress we have made in preparation of this important study and look forward to recruiting the first patient into ACCLAIM-II," commented Chris Waddick, President and CEO of Vasogen. "With today's announcement of the initial orders for Celacade in Europe, where Celacade is already approved, and the planned initiation of ACCLAIM-II, 2008 promises to be an exciting time for Vasogen."

About Vasogen:

Vasogen is a biotechnology company engaged in the research and commercial development of therapies designed to target the destructive inflammatory process associated with the development and progression of cardiovascular and neurodegenerative disorders. The Company's lead product, the Celacade System, is designed to activate the immune response to apoptosis - an important physiological process that regulates inflammation. Celacade is in late-stage development for the treatment of chronic heart failure and has received European regulatory approval under the CE Mark for this indication. Vasogen is also developing a new class of drugs for the treatment of certain neuro-inflammatory disorders. VP02
'/>"/>

SOURCE Vasogen Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Vasogen Announces Third Quarter Conference Call and Webcast of Bio InvestorForum 2007 Presentation
2. Vasogen Announces Third Quarter 2007 Results
3. Vasogen to Webcast Presentations at Three Upcoming Healthcare Conferences
4. CardioDynamics Provides 2007 Shareholder Meeting Update
5. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
6. NxStage Medical Provides Update on Medisystems Acquisition
7. VaxGen Files 2006 Financial Statements and Provides Cash Update
8. Signalife Provides Corporate Update
9. Revolutionary Genomics Research Group Opens Boston Office; Provides DNA Evidence in Workers Comp Cases
10. Elekta Contract Provides Sisters of Mercy Health System Access to Leading Radiation Therapy Solutions
11. SGX Provides Update on BCR-ABL Collaboration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... 2014 Deep Research Report ... professional and in-depth research report on the ... Seaweed Fertilizer information, including Seaweed Fertilizer definition, ... well as industry overview. This research covers ... as well as global industry analysis covering ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 The College ... first private college in the Mid-Hudson Region to be ... now begin accepting applications from qualified “high-technology” businesses that ... are very pleased to have been selected for the ... Cuomo’s transformative initiative to stimulate economic development in New ...
(Date:8/21/2014)... HONG KONG , Aug. 21, 2014  China Cord ... today announced its plan to release financial results for ... August 28, 2014, after market close in the US.  ... call at 8:00 a.m. ET on Friday, August 29, ... brief overview of the Company,s recent developments, followed by ...
(Date:8/21/2014)... MO (PRWEB) August 21, 2014 ... service biopharmaceutical contract development and manufacturing organization (CMO) ... Progenics Pharmaceuticals, Inc., an oncology company focused on ... treating cancer, to manufacture the anti-prostate specific membrane ... ADC product candidate. Under the agreement the ...
Breaking Biology Technology:Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 2Internationals Seaweed Fertilizer Industry 2014 Development Trend Analysis in New Research Study at DeepResearchReports.com 3The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 2The College of New Rochelle Becomes First Private College in Mid-Hudson Region to Earn START-UP NY Designation 3China Cord Blood Corporation to Report First Quarter of Fiscal 2015 Financial Results 2Gallus Enters Agreement with Progenics Pharmaceuticals, Inc. for Manufacture of Anti-PSMA Monoclonal Antibody 2Gallus Enters Agreement with Progenics Pharmaceuticals, Inc. for Manufacture of Anti-PSMA Monoclonal Antibody 3
... Revenue Increased 61% Compared to 3Q06 to $43.5 Million in 3Q07 -,- 3Q07 ... ... Share - - Company Provides Financial ... Oriental,Bioengineering, Inc. (NYSE: AOB ), a leading manufacturer and distributor of,plant-based pharmaceutical ...
... ... up 10%, Compared to Third Quarter 2006 FFO Per Share (Diluted) of ... $1.32 - Third Quarter 2007 Total Revenues up 23%, FFO Available to ... Stockholders up 21% - Third Quarter 2007 Earnings Per Share (Diluted) ...
... Bruker Daltonics today,announced the availability of its ... poster presentations on its website at, http://www.bdal.com . ... Characterization and General Mass Spectrometry, -- Novel ... Peptide Characterization Poster M103 ...
Cached Biology Technology:American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 2American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 3American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 4American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 5American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 6American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 7American Oriental Bioengineering Reports Third Quarter 2007 Financial Results 8Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 2Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 3Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 4Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 5Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 6Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 7Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 8Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 9Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 10Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 11Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 12Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 13Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 14Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 15Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 16Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 17Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 18Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 19Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 20Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 21Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 22Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 23Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 24Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 25Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 26Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 27Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 28Alexandria Real Estate Equities, Inc. Reports Third Quarter 2007 Results 29
(Date:8/22/2014)... to important discoveries in basic and clinical research ... mobilized into a complex offensive spanning multiple fronts. ... chemistry lab could help find new and more ... compound that targets a specific enzyme overexpressed in ... cells from brain tumours. , Chemistry professor Christopher ...
(Date:8/22/2014)... be able to purchase fuel cell cars from Toyota ... of the cars will run on hydrogen made from ... warming. , Now scientists at Stanford University have developed ... battery to produce hydrogen by water electrolysis. The ... split liquid water into hydrogen and oxygen gas. Unlike ...
(Date:8/21/2014)... SHELTON, Conn. , Aug. 21, 2014 ... on the growing mobile commerce market, announced today that ... purchase common stock to be issued in its proposed ... been approved for listing on The Nasdaq Capital Market, ... of the common stock and warrants, and will trade ...
Breaking Biology News(10 mins):New enzyme targets for selective cancer therapies 2New enzyme targets for selective cancer therapies 3Stanford scientists develop a water splitter that runs on an ordinary AAA battery 2Stanford scientists develop a water splitter that runs on an ordinary AAA battery 3Nxt-ID Approved for NASDAQ Capital Market Listing 2Nxt-ID Approved for NASDAQ Capital Market Listing 3
... 9, 2010A subset of children with asthma suffers ... and greater allergic hypersensitivity, according to the results ... Severe Asthma Research Program (SARP), presented in a ... and Pulmonology , a peer-reviewed journal published by ...
... into how plants slow their growth in cold weather could ... have shown for the first time that a gene ... cool temperatures, possibly helping them adjust to cool conditions. ... the study, believe that by manipulating the gene, they could ...
... The Office of Naval Research (ONR) has awarded ... researchers from Boston University, the University of Washington, the ... at Chapel Hill. The grant will fund a project ... Loop Strategies), which will focus on the development of ...
Cached Biology News:Research and insights on severe asthma in children 2BU partners in 5-year, $7.5M grant to study animal flight 2
DAPI: 4', 6-Diamino-2-phenylindole dihydrochloride. Antifade Solution: p-Phenylenediamine and glycerol in PBS solution. 0.4g/mL DAPI suspended in Antifade....
Takara's Mutan-Super Express Km Kit is designed to achieve site-directed mutagenesis in just one day. It is based on Oligonucleotide-directed Dual Amber (ODA) method, using the advantages of LA (Long...
... Insect Cell Medium are recommended for protein ... combination has been selected based on rapid, ... levels observed specifically with baculoviruses derived from ... Ready-Plaque Sf9 Cells and BacVector Insect Cell ...
...
Biology Products: