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

BP, the Company should establish a special protocol assessment (SPA) using a superiority clinical trial design comparing Restanza to a marketed macrolide antibiotic in two clinical trials.

In light of this guidance, Advanced Life Sciences is working with the FDA to finalize a SPA using a superiority design for the outpatient CABP indication.  Clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population will be the primary endpoint.

"We are pleased that the Agency provided clear guidance regarding our registration pathway for Restanza in the CABP and biodefense indications.  Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumoniae," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Based on the data we have accumulated in our extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, we believe that Restanza can show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs.  With reported macrolide resistance rates as high as 40 percent in the U.S., there is a pressing medical need for new drugs to treat CABP.  Our goal is to finalize the SPA by the end of the third quarter of this year."


'/>"/>
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:7/24/2014)... to materialise. Yet, scientists are making progress in ... One such approach relies on quantum dotsa kind ... electric field. A new study demonstrates that changing ... (TQDs) with electrical impulses can help better control ... be used as quantum information units, which would ...
(Date:7/24/2014)... Research and Markets has announced ... Analytical Instruments Market 2014-2018" report to their offering. ... Genomics is the study of the gene and its ... and functions of proteomes or sets of proteins by ... involves the mapping of genes and DNA sequencing to ...
(Date:7/24/2014)... 24, 2014 Three companies from the ... Livestrong’s Big C Competition. Out of 700 competition entrants, ... to the semi-final round. In this round twenty teams ... program, complete with mentoring from thought-leaders and medical entrepreneurs ... of the angelMD commitment to the Livestrong vision around ...
(Date:7/24/2014)... July 24, 2014 1000 balances – ... input on customers’ weighing needs and expertly narrows down ... of balances, scales or even terminals. , First, ... smallest weight (or select readability instead) and define the ... additional selection criteria narrows down the list to models ...
Breaking Biology Technology:Global Genomics and Proteomics Analytical Instruments Market 2014-2018: Key Vendors are Agilent, Bio-Rad , F. Hoffmann, La Roche, Illumina, PerkinElmer and Thermo Fisher Scientific 23 angelMD Startups Make Livestrong Big C Semi-finals 2
... knowingly misrepresented the ... company to ... filed a,proposed class-action lawsuit on behalf of CellCyte Genetics Corporation,(OTC ... and chief executive officer Gary A.,Reys, background, causing company stocks ...
... SAN DIEGO, Jan. 18 The San Diego ... has received the,highest score in three of four ... on Part I of the Major Facilities Grant,Application., ... earned scores of,99 for basic research and discovery, ...
... objects to implications in a New York Times article ... clinical,trials., The story, based on a separate article ... and Lilly as high-profile examples of how the,industry purportedly ... story inaccurate when it comes to Prozac -- the ...
Cached Biology Technology:Hagens Berman Sobol Shapiro: Lawsuit Filed Against CellCyte Genetics Corporation 2Hagens Berman Sobol Shapiro: Lawsuit Filed Against CellCyte Genetics Corporation 3SDCRM Receives Highest Score in Three of Four Categories from CIRM on Part I of Major Facilities Grant Application 2SDCRM Receives Highest Score in Three of Four Categories from CIRM on Part I of Major Facilities Grant Application 3In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Company issued the following statement: 2In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Company issued the following statement: 3In response to a New England Journal of Medicine article published yesterday and subsequent media coverage, Eli Lilly and Company issued the following statement: 4
(Date:7/25/2014)... New research at the University of Adelaide has opened the ... resistance to powdery mildew. , In Australia, annual barley production ... year. Powdery mildew is one of the most important diseases ... team have discovered the composition of special growths on the ... the fungus into the leaf. , The research, by the ...
(Date:7/25/2014)... central nervous system disease that is caused by ... the embryonic phase. Many patients have varying degrees ... retardation. Such problems decrease the patients, functional independence ... Physical Medicine and Rehabilitation Education and Research Hospital, ... SB, using the Pediatric Evaluation of Disability Inventory ...
(Date:7/25/2014)... that the age girls reach puberty is influenced by ,imprinted ... parent contributes the gene. This is the first evidence ... birth and details of this study were published today in ... period, known as menarche, is a marker for the timing ... onset of menses varies between girls, is an inherited trait, ...
Breaking Biology News(10 mins):New hope for powdery mildew resistant barley 2Could age of first period influence development of diseases in older women? 2
... provide key insights for scientists and medical researchers, but ... pose some key challenges. Researchers at North Carolina ... the parameters used in such models which may ... fertility. "These oscillatory systems are found in everything ...
... facility in the US, researchers at the University of Gothenburg have ... is to film how proteins work at molecular level. ... cells could be the key to cures for everything from cancer ... University of Gothenburg, and his research group were among the first ...
... Carrying a gun in bear country doesn,t mean you,re more protected ... out of Brigham Young University. A study led by BYU ... gun is no more effective in keeping people from injury or ... really isn,t about the kind of gun you carry, it,s about ...
Cached Biology News:New method for estimating parameters may boost biological models 2New method for estimating parameters may boost biological models 3More effective method of imaging proteins 2BYU study: Using a gun in bear encounters doesn't make you safer 2
... Versatile, modular, computer controlled pre-amplifier suitable for ... isolated electrode input for recording physiological signal ... and a transducer input for use with ... transducers. Additional options include a stimulus artefact ...
... Polystyrene covers can be used ... Ridged covers for stacking of ... covers for use with automated ... ridged and non-ridged, are available ...
... available for use with 96- or 384-well PCR plates ... ease of location on 96-tube plates End tabs ... of the plate* Efficient sealing is achieved with ... with screw or clip-down hot lid thermal cyclers ...
... be used with all 96-well ... stacking of covered plates ... with automated systems ... are available for use with ...
Biology Products: