Navigation Links
U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur and KaloBios' Novel Biologic Candidate for Pseudomonas aeruginosa
Date:4/23/2013

CHICAGO, April 23, 2013 /PRNewswire/ --



Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), and KaloBios Pharmaceuticals (Nasdaq: KBIO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically-ventilated patients. The Fast Track Drug Development Program of the FDA is designed to facilitate the clinical development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.  The joint announcement was made on this second day of the BIO International Convention, the 20th annual meeting of the world's largest biotechnology organization.

     (Logo: http://photos.prnewswire.com/prnh/20130423/610748-a)

     (Logo: http://photos.prnewswire.com/prnh/20130423/610748-b)

Most serious Pa infections occur in hospitalized and critically or chronically ill patients--primarily affecting the respiratory system in susceptible individuals--and are a serious clinical problem due to the bacteria's resistance to antibiotics. Sanofi Pasteur, which is responsible for the clinical development under the terms of the agreement with KaloBios, is currently conducting a phase I trial of the monoclonal antibody in the United States and has started the planning of a phase IIb study.  

"Sanofi Pasteur is currently targeting the antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospital
'/>"/>

SOURCE Sanofi Pasteur
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related biology technology :

1. R&D Systems is Offering Travel Grants to Attend the 15th International Congress of Immunology
2. Cellular Dynamics and Coriell Institute for Medical Research Awarded Multi-Million Dollar Grants from California Institute for Regenerative Medicine to Manufacture and Bank Stem Cell Lines
3. Hadasit Bio-Holdings Ltd. Portfolio Companies - ProtAb Ltd. and KAHR Medical Ltd. to Receive NIS 10.7 Million (Over $2.8 Million USD) in Additional Government Grants
4. Immunology 2013™ Travel Grants Available from R&D Systems
5. SomaGenics Announces Issue of Key Patent for Its sshRNA Technology and Receipt of Two New Small Business Innovation NIH Grants
6. Symphogen Grants Exclusive Worldwide License of Phase II Oncology Drug Candidate Sym004 to Merck KGaA
7. The Leukemia & Lymphoma Society Awards $12 Million in Research Grants in Four Critical Areas of Unmet Medical Need
8. USPTO Grants Butamax a Further KARI Enzyme Patent
9. Enox Biopharma, Inc. Grants TTA LTD License To Wound Care Applications
10. FDA Grants Lexicon Orphan Drug Designation for Telotristat Etiprate for the Treatment of Carcinoid Syndrome
11. Heptares Grants Shire an Exclusive Worldwide Licence to Develop and Commercialise Novel Drug Candidate for CNS Disorders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... Charlotte, NC (PRWEB) October 24, 2014 ... high intensity focused ultrasound (HIFU) technology, announced that ... Carol, M.D. as Chief Executive Officer, President and ... new role Dr. Carol will take-on expanded responsibilities ... HIFU technology, as well as overseeing commercialization, manufacturing ...
(Date:10/25/2014)... JERUSALEM , October 24, 2014 ... a clinical-stage pharmaceutical company focused on the development of ... CEO, Nadav Kidron will present at FireRock ... ,FireRock Capital,s Annual Micro-Cap Conference ,Date: Tuesday, October 28, ... Building, New York City , ...
(Date:10/25/2014)... 2014 Investor-Edge has initiated coverage ... CYTR ), Vertex Pharmaceuticals Inc. (NASDAQ: VRTX ... Peregrine Pharmaceuticals Inc. (NASDAQ: PPHM ), and ... companies can be accessed at: http://investor-edge.com/register . ... ended on a positive note as the Dow Jones ...
(Date:10/22/2014)... 22, 2014 New test innovations will be ... diagnostic (IVD) test industry, especially as companies struggle with ... listed more than 25 testing innovations in important disease ... of IVD products. Kalorama details the new approaches its biennial ... for In Vitro Diagnostic Tests , 9th Edition ...
Breaking Biology Technology:SonaCare Medical Board of Directors Appoints Dr. Mark Carol as CEO and President 2SonaCare Medical Board of Directors Appoints Dr. Mark Carol as CEO and President 3Oramed to Present at the FireRock Annual Micro-Cap Conference 2Oramed to Present at the FireRock Annual Micro-Cap Conference 3Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 2Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 3Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 4Biotech Stocks Technical Data - CytRx, Vertex Pharma, Alexion Pharma, Peregrine Pharma, and StemCells 5Report: Radical New IVD Test Approaches Key To Growth 2Report: Radical New IVD Test Approaches Key To Growth 3
... Inc. (Nasdaq:,BIOD) today reported financial results for its second quarter ... $9.6 million or $0.43 per share., "We remain on ... and Chairman of Biodel. "The last patient visits for,both pivotal ... We,expect to announce top line data late in the third ...
... Pennsylvania and OXFORD, England, May 9 ,EUSA Pharma ... oncology, pain control and critical care, today announced ... following the,approval of Cytogen,s shareholders at a special ... of the acquisition agreement, Cytogen shareholders will,receive $0.62 ...
... Pharmaceuticals, Inc.,(Nasdaq: ARNA ) announced today that the ... 2008 Healthcare Conference on May 14, 2008 at 5:20 ... Seasons Hotel in Las,Vegas, Nevada. Dominic P. Behan, Ph.D., ... to provide an overview of the,company, including its clinical ...
Cached Biology Technology:Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 2Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 3Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 4Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 5Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 6Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 7Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 8Biodel Inc. Reports Second Quarter Fiscal Year 2008 Financial Results 9EUSA Pharma Completes Acquisition Of Cytogen Corporation 2EUSA Pharma Completes Acquisition Of Cytogen Corporation 3Arena Pharmaceuticals to Present at the Bank of America 2008 Healthcare Conference 2Arena Pharmaceuticals to Present at the Bank of America 2008 Healthcare Conference 3
(Date:10/16/2014)... challenged conventional thinking on how the bowel lining develops ... how bowel cancer starts. , The researchers produced evidence ... the ,crypts, that are a feature of the bowel ... bowel cancer development, a controversial finding as scientists are ... 3D imaging technologies, Dr Chin Wee Tan and Professor ...
(Date:10/16/2014)... Syncytial Virus causes severe respiratory tract infections and ... year. Scientists at VIB and Ghent University have ... counteract this common virus infection. , Xavier ... that paves the way for the development of ... virus that causes suffering in numerous small children ...
(Date:10/16/2014)... , October 16, 2014 NXT-ID, Inc. ... the "Company"), a biometric authentication company focused on the ... leading edge technologies including Wocket™, the Smart Wallet, at ... Conferenece. FiRe is a leading global conference on the ... Hosted by Mark Anderson , founder and publisher ...
Breaking Biology News(10 mins):Cryptic clues drive new theory of bowel cancer development 2New perspectives for development of an RSV vaccine 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 3
... In recent years, the possible applications for double-walled ... those working on developing renewable energy technologies. These ... thin enough to be transparent, yet can still ... advanced solar panels, sensors and a host of ...
... for Glycomics in collaboration with colleagues at the ... to identifying a broad spectrum treatment for the ... These highly-infectious viruses are the leading cause of ... of hospitalisations in the developed world, and hundreds ...
... Dec. 23, 2008 -- The reproductive spores of many ... to new research by mycologists and applied mathematicians at ... this week in the Proceedings of the National ... fungal spores is within one percent of the absolute ...
Cached Biology News:Researchers find chink in the armor of viral 'tummy bug' 2In many fungi, reproductive spores are remarkably aerodynamic 2
Porcine Coronary Artery Smooth Muscle Cells (PCASMC) (>500,000 cells)...
... T4 DNA Ligase catalyzes the joining of ... and the 3´-hydroxyl groups of adjacent nucleotides ... (1). The enzyme has also been shown ... either a DNA or RNA strand in ...
... Chain MAP1A and MAP1B are microtubule-associated proteins ... components of the cytoskeleton. MAP1A and MAP1B each ... light chain subunits. The protein encoded by this ... and can associate with either MAP1A or MAP1B. ...
PC based system for advanced chemifluorescent, chemiluminescent, fluorescent and colorimetric, microarray and microscope imaging and analysis....
Biology Products: