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:10/22/2014)... , Oct. 22, 2014  Actavis plc (NYSE: ... and Rhythm, a biopharmaceutical company, today announced that Actavis ... wholly owned subsidiary, Rhythm Health, Inc., which is developing ... of diabetic gastroparesis and other GI functional disorders. ... trial of relamorelin for the treatment of diabetic gastroparesis ...
(Date:10/22/2014)... 21, 2014 The North American crystal ... North America with analysis and forecast of revenue. This ... is expected to reach $623.6 million by 2018, at ... Browse through the TOC of the North American crystal ... in-depth analysis provided. This also provides a glimpse of ...
(Date:10/22/2014)... 2014 Involution Studios , a ... a new infographic, Understanding Ebola . The ... designed, easy to follow informative tool for anyone wanting ... symptoms and prevention. , "As the news has spread ... Ebola outbreak represents not only a healthcare crisis with ...
(Date:10/22/2014)... 2014 Currently offering a comprehensive ... D Weighing, Rice Lake, and Ohaus, Pipette.com has ... The Sartorius CPA Semi-Micro Balance is ideal for ... and user-friendly laboratory balance. , Sartorius is a ... laboratory balances are well known for their high ...
Breaking Biology Technology:Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 2Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 3Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 4Actavis Signs Option to Acquire Rhythm Subsidiary and its GI Development Product, Relamorelin 5The North American crystal oscillator market is expected to reach $623.6 million by 2018 - New Report by MicroMarket Monitor 2The North American crystal oscillator market is expected to reach $623.6 million by 2018 - New Report by MicroMarket Monitor 3The North American crystal oscillator market is expected to reach $623.6 million by 2018 - New Report by MicroMarket Monitor 4Involution Studios' Ebola Infographic Provides Key Disease Information and Statistics at a Glance 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 2Pipette.com Launches the Addition of Sartorius CPA Semi-Micro Balance to Their Product Portfolio with Special Promotional Pricing 3
... the weeks since DEMO 2007, I've had the chance to ... site, Jaman.com . Launched at the conference, Jaman.com offers ... or buy at prices that average about $6 per film. ... core of the Jaman.com experience is the downloadable player, a ...
... Wis. - Looking to raise more venture capital for ... 30 firms presenting at the annual InvestMidwest venture capital ... which also presented at the 2006 forum, would like to ... Phase I clinical trials that are set to begin in ...
... a recent column for the Wisconsin Technology Network , Gov. ... Wisconsin System fueling our state's economy. The governor missed the mark. ... the best in the country. In order to remain on top, however, ... done little of since it was created in 1971. The UW System ...
Cached Biology Technology:We're "Jaman": Purpose-driven browsers drive next wave of Web applications 2We're "Jaman": Purpose-driven browsers drive next wave of Web applications 3ZyStor seeks to raise $15M for clinical trials 2ZyStor seeks to raise $15M for clinical trials 3UW System must remove barriers to innovation 2UW System must remove barriers to innovation 3UW System must remove barriers to innovation 4
(Date:10/15/2014)... -- NXT-ID, Inc. (NASDAQ: NXTD and NXTDW) ("NXT-ID" ... mobile commerce market releases photos and video of the recent opening ... 13 th . Gino Pereira , CEO ... investor Mr. Chad A. Verdi rang the bell.  ... investors and employees "for their work and dedication in bringing the ...
(Date:10/15/2014)... Lithuania , Oct. 15, 2014   ... technologies, today announced the availability of the ... VeriLook Surveillance 3.0 provides real-time biometric face identification ... high-resolution digital surveillance cameras. The new version not ... and differentiates people from objects while they are ...
(Date:10/14/2014)... Cancer Research shows SIRT6—a protein known to ... the development of skin cancers by turning on an ... skin cells. , Previously considered protective, SIRT6 is part ... help regulate genomic stability and prevent some of the ... damage, which can lead to cancer. This study, in ...
Breaking Biology News(10 mins):Photo Release: NXT-ID Inc. Rings Opening Bell of the NASDAQ Stock Market October 13th 2Photo Release: NXT-ID Inc. Rings Opening Bell of the NASDAQ Stock Market October 13th 3VeriLook Surveillance 3.0 SDK Identifies Faces and Moving Objects, Differentiates Pedestrians from Other Moving Objects in Video Surveillance Systems 2VeriLook Surveillance 3.0 SDK Identifies Faces and Moving Objects, Differentiates Pedestrians from Other Moving Objects in Video Surveillance Systems 3Two-faced gene: SIRT6 prevents some cancers but promotes sun-induced skin cancer 2
... - Eurofins MWG Operon, an expert in next generation sequencing ... libraries for sequencing with Roche GS FLX or Illumina HiSeq ... long paired end (LPE) libraries with different jumping distances (3 ... After sequencing, the resulting reads are assembled into large contigs ...
... of a TB Vaccine PDP, An Exhibitor,s Workshop at the ... 1:00-2:00 PM VENUE: 2011 AAAS ANNUAL MEETING, ,WASHINGTON CONVENTION ... an overview of the state of the global TB epidemic ... product development partnerships such as Aeras; and ways that scientists ...
... found attached to the foot of an ancient Egyptian mummy ... parts, says the scientist who tested replicas on volunteers. ... a three-part wood and leather artefact housed in the Egyptian ... Chester artificial toe on display in the British Museum, not ...
Cached Biology News:Mummies' false toes helped ancient Egyptians walk 2
Anti-Rat KAPPA/LAMBDA:HRP, Clone MARK-1/MARL-15, Monoclonal Antibody...
MOUSE ANTI RAT KAPPA/LAMBDA:HRP Immunogen: MARK-1: Rat kappa light chains (IR202 and IR968)MARL-15: Rat lambda light chains (RH58, IR31)...
Request Info...
Request Info...
Biology Products: