Navigation Links
Advanced Life Sciences Receives FDA Guidance on Approval Pathway for Restanza in Community Acquired Bacterial Pneumonia and Biodefense Indications
Date:3/11/2010

Advanced Life Sciences also announced that it received notice from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services that it has completed its initial technical evaluation of the Company's $15 million funding proposal for advanced development of Restanza as a biodefense countermeasure and identified it as a scientifically and technically sound proposal important to program goals and objectives that may require further development and may be recommended for acceptance subject to funds availability.  The Company was invited to submit additional information to allow BARDA to make a final determination on the appropriateness of the proposal to enter into contract negotiations.

Related to this development, Advanced Life Sciences also gained clarity from the FDA on the biodefense regulatory package required for submission in light of recent AIDAC meetings discussing the use of the FDA's Animal Rule for approval of biodefense therapeutics. As anticipated, the FDA recommended that, in parallel with pivotal animal studies demonstrating efficacy under FDA's Animal Rule, Advanced Life Sciences should complete the CABP clinical program and submit a complete response to the CABP new drug application (NDA) prior to submitting an amended NDA for the biodefense indications.

Commented Dr. Fl
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
3. Advanced Cell Technology Announces Proposed Financing
4. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
5. Advanced Cell Technologys Dr. Robert Lanza Makes List of 100 Most Inspiring People in the Life-Sciences Industry
6. Advanced Life Sciences to Present at 2007 UBS Global Life Sciences Conference
7. CeloNova BioSciences Announces Worlds First Line of Fully Color-Coded Embolic Particles at CIRSE: Embozene(TM) Color-Advanced Microspheres
8. Edwards Lifesciences Grants UC Irvine $5 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology
9. Advanced Bionics Deploys CEVA-TeakLite(TM) DSP Core to Enhance Its Harmony(TM) HiResolution(R) Bionic Ear System
10. NIH Announces Advanced Cell Technologys Single Cell Embryo Biopsy Technique as a Means to Derive Embryonic Stem Cells to be Considered for Federal Funding
11. Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... The report expects global cell isolation and ... also provides a carefully analyzed data about the vital ... market. , Full Copy of Report @ http://bit.ly/1yUxy0T ... for cell expansion will keep witnessing growth at an ... to be driven by rapid technological advancements, government funding ...
(Date:12/24/2014)... LONDON , December 23, 2014 ... Review Algeria , out today and available for free ... the actors driving change and growth in the sector today. ... has scored notable successes has been in developing a homegrown ... 70 percent local production still remains some way off. A ...
(Date:12/22/2014)... The Center for Professional Innovation ... training across the life sciences industry, has partnered with ... to provide the organization's members with discounted classroom courses, ... the more than 350 sessions across 80 course titles. ... when registering for a public course at ...
(Date:12/22/2014)... DIEGO , Dec. 22, 2014 GenomeDx ... the Decipher Prostate Cancer Classifier, a genomic test for ... in node-negative, high-risk men managed by radical prostatectomy without ... radical prostatectomy is relatively uncommon, using tumor genomics to ... of metastatic disease is an important advance. The study ...
Breaking Biology Technology:The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 2The Cell Expansion Market is Expected to Reach $14.8 billion by 2019 - New Research Report by MarketsandMarkets 3PharmaBoardroom Releases New Algeria Pharmaceuticals Report 2PharmaBoardroom Releases New Algeria Pharmaceuticals Report 3CfPIE Announces Partnership with the Society for Clinical Data Management 2CfPIE Announces Partnership with the Society for Clinical Data Management 3Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 2Study Published in European Urology Shows that the Decipher Prostate Cancer Classifier is Predictive of Rapid Metastasis in High-Risk Men who have had Prostate Surgery 3
... the manufacturer of,medical aesthetic lasers, announced today that ... Sanders Morris Harris Group (Nasdaq: SMHG ), ... fund expansion into,new markets., The additional funding ... channel expansion into the market of about 300,000 ...
... Sept. 19 Tengion Inc., a clinical,stage regenerative ... neo-tissues, today announced that it was one of ... innovation and,success at the 35th Anniversary Celebration of ... Partner at Quaker BioVentures -- a,venture capital investor ...
... Thirty seven medical,experts in psychiatry from across ... take urgent action to optimize services for people ... schizophrenia or bipolar,disorder(i)., Professor W. Wolfgang Fleischhacker, ... Severe Mental Disorders: Clinical,Policy, and Research Challenges which ...
Cached Biology Technology:Aerolase Retains SMH Capital Inc. to Advise on Corporate Expansion 2Tengion Featured as Model of Innovation and Success at 35th Anniversary Celebration of the National Venture Capital Association 2Global Psychiatrists Unite to Improve Services in Mental Health 2Global Psychiatrists Unite to Improve Services in Mental Health 3
(Date:12/11/2014)... PAUL, Minn. , Dec. 10, 2014 /PRNewswire/ ... wireless physiologic monitoring, has released a new series ... needs of preclinical toxicology researchers. M series, part ... help toxicologists collect the best possible physiologic data ... Adding functional endpoints to toxicology studies ...
(Date:12/10/2014)... , Dec. 9, 2014  Wake Forest Baptist Medical ... building for its School of Medicine. Funding for this ... capital campaign that will be publicly launched next summer. ... located in the former 60 series R.J. Reynolds Tobacco ... Quarter. Construction will begin immediately with plans to be ...
(Date:12/10/2014)... California , December 9, 2014 ... with ITN,s BCARD Platform   ... cloud-based enterprise meeting scheduling solutions for business-to-business (B2B) ... the world leader in mobile near-field communication (NFC), ...      (Logo: http://photos.prnewswire.com/prnh/20140612/691055) , ...
Breaking Biology News(10 mins):New telemetry implants expected to change how large animal toxicology studies are conducted 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 3Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 4Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 2Jifflenow And ITN International Bring Cutting-Edge Badge Scanning Technology To B2B Events 3
... MD The Federation of American Societies for ... for the Science Research Conference (SRC): Neural Mechanisms ... Research Conference, Neural Mechanisms in Cardiovascular Regulation, is ... focus on neural mechanisms that regulate normal cardiovascular ...
... Federation of American Societies for Experimental Biology (FASEB) ... Research Conference (SRC): Matricellular Proteins in Development, Health, ... surrounding extracellular matrix (ECM) are the basis for ... organization in all metazoan organisms. Structural ECM components ...
... Bethesda, MD The Federation of American Societies ... registration for the Science Research Conference (SRC): Hematologic ... Malignancies is an important and unique scientific conference ... and myeloma is presented in detail in the ...
Cached Biology News:FASEB SRC announces conference: Matricellular Proteins in Development, Health, and Disease 2
Raised to 5-HIAA coupled to BSA with paraformaldehyde....
NuCycl DAPI Kit Application: Flow Cytometry Reactivity: Human...
Request Info...
ChIP-GLAS kit for H10K-B microarray chips. Contains ChIP kit, GLAS kit, and hybridization kit. Additional reagents are required. Please see manual for details. Contains sufficient reagent for 20 reac...
Biology Products: