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:4/24/2015)... 24, 2015 DryLet, LLC a ... applications such as animal waste reduction, bioremediation, wastewater ... in wastewater treatment plants and restaurant kitchen settings, ... the National Restaurant Association’s NRA Show 2015, in ... of the company will be available to share ...
(Date:4/24/2015)... Telbec/ - Mirego, leader in mobile strategies and solutions, is ... app extensions for the all new Apple Watch. Made in ... and MediaMiser, these extensions will reinvent the way users receive ... wrist use.  Available today in ... tactile smartwatch that makes for an excellent buddy for business, ...
(Date:4/24/2015)... April 24, 2015 Seoul Semiconductor ... for various applications in the lighting market. ... installations of this technology in emerging markets such ... a wide range of applications such as streetlight ... decorative lighting. , First launched in 2005 the ...
(Date:4/23/2015)... 23, 2015 The Thomas Brain ... conduct a groundbreaking pilot study to see if ... in as little as three to six months. ... and nutritional medicine—will aggressively target and simultaneously treat ... our aging brain. These include oxidative stress, neuroinflammation, ...
Breaking Biology Technology:DryLet to Showcase Bio-React at the National Restaurant Association’s NRA Show 2015 May 16-19, 2015 in Chicago, Illinois 2Familiprix, OMSignal and MediaMiser apps available today for Apple Watch 2Acrich Technology from Seoul Semiconductor Adopted in Installations Worldwide 2New Study Looks to Reverse Alzheimer’s Disease 2New Study Looks to Reverse Alzheimer’s Disease 3
... , NEW YORK, Aug. 5 ... biopharmaceutical company focused on the acquisition, development and commercialization ... of life-threatening diseases, including renal disease and cancer (the ... ended June 30, 2009. , , ...
... , , SAN DIEGO, ... ), a biopharmaceutical company focused on in-licensing, developing and commercializing ... today reported financial results for the three and six months ... the second quarter of 2009, Cadence submitted its New Drug ...
... CARLISLE, Mass., Aug. 5 CapitalBio ... of a fully integrated microarray solution platform. CapitalBio ... and advanced microarray instrument systems, in collaboration with ... instrumentation software, now offers a platform that combines ...
Cached Biology Technology:Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results 2Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results 3Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results 4Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results 5Keryx Biopharmaceuticals, Inc. Announces Second Quarter 2009 Financial Results 6Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 2Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 3Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 4Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 5Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 6Cadence Pharmaceuticals Reports Second Quarter 2009 Financial Results 7CapitalBio Corporation and VigeneTech Inc. Have Announced the Launch of a Fully Integrated Microarray Solution Platform 2CapitalBio Corporation and VigeneTech Inc. Have Announced the Launch of a Fully Integrated Microarray Solution Platform 3
(Date:4/10/2015)... 2015 Research and Markets ( ... "Security Competitive Profiles - NEC" report to their ... NEC will continue to supply a range of IT ... a company focus on the development of a Big ... opportunities in the Asia-Pacific region ...
(Date:4/2/2015)... , April 2, 2015 At its ... Salt Lake City , the American College of ... five new directors to its Board.  Members of the ... ACMG and for forming and advancing its policies and ... genetics profession. "It,s an eventful time in ...
(Date:3/31/2015)... March 31, 2015  Elephant Talk Communications Corp. (NYSE ... provider of Software Defined Network Architecture (ET Software DNA® ... revenue of approximately $20.4 million for the year ended ... million for the year ended December 31, 2013. ... Company had completed its multi-year transition away from its ...
Breaking Biology News(10 mins):NEC Security Competitive Profile 2015 2American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 2American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 3American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 4American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 5American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 6American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 7American College of Medical Genetics and Genomics Announces New Board Members: Dr. Louanne Hudgins is ACMG President-Elect 8Elephant Talk Reports 2014 Fourth Quarter and Year End Financial Results 2Elephant Talk Reports 2014 Fourth Quarter and Year End Financial Results 3Elephant Talk Reports 2014 Fourth Quarter and Year End Financial Results 4Elephant Talk Reports 2014 Fourth Quarter and Year End Financial Results 5Elephant Talk Reports 2014 Fourth Quarter and Year End Financial Results 6
... a clear agenda when it comes to selecting a mating ... preferring large females, they are likely to have more and ... Mattle and Tony Wilson from the Zoological Museum at the ... just been published online in Springer,s journal Behavioral Ecology ...
... two common dietary oil supplements affect body composition suggests ... in obese postmenopausal women with Type 2 diabetes. ... cooking oil, and conjugated linoleic acid (CLA), a compound ... has been associated with weight loss in previous studies. ...
... Tiny flying machines can be used for everything ... simply making smaller versions of planes and helicopters ... Carolina State University are mimicking nature,s small flyers ... maneuverability and performance. Small flyers, or micro-aerial ...
Cached Biology News:Male seahorses like big mates 2Two dietary oils, two sets of benefits for older women with diabetes 2Two dietary oils, two sets of benefits for older women with diabetes 3Two dietary oils, two sets of benefits for older women with diabetes 4Robo-bats with metal muscles may be next generation of remote control flyers 2
PKC (pSer345), phospho-specific...
Anti-ADAMTS-4, disintegrin-like domain Immunogen: Synthetic peptide - KLH conjugated Available Date: 38569...
Rabbit polyclonal to Streptococcus Enterotoxin C ( Abpromise for all tested applications)....
... 100 g monoclonal antibody which can ... V from heart mitochondria. Also included are ... control immunocapture. The Complex V immunocapture kit ... (E.C. 3.6.3.14) from small amounts of tissue. ...
Biology Products: