Navigation Links
Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia
Date:7/31/2009

CHICAGO, July 31 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced that it received a complete response letter today from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Restanza(TM) (cethromycin) for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP). In its letter, the FDA indicated that they cannot approve the application for Restanza in its current form and that, to gain approval, additional clinical data is required to demonstrate efficacy. Advanced Life Sciences submitted the NDA in September, 2008 based on the results of 53 clinical studies including 2 pivotal Phase 3 studies in CAP and a safety database of over 5,000 patients.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

Advanced Life Sciences intends to comply with the Agency's recommendations and continue to pursue approval of Restanza in CAP. The Company believes that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. In parallel, the Company will continue to advance Restanza as a biodefense agent against anthrax, plague and tularemia.

On June 2, 2009, the FDA Anti-Infective Drugs Advisory Committee (AIDAC) reviewed the Restanza NDA. The AIDAC voted that Restanza demonstrated safety for the outpatient treatment of adults with mild-to-moderate CAP, but voted that Restanza did not demonstrate efficacy in the treatment of CAP. The committee's negative vote on the drug candidate's efficacy followed a discussion that the Restanza NDA included data on patients with mild-to-moderate disease and that the new draft guidance for developing treatments for CAP, released in March, 200
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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:8/21/2014)... On Wednesday of last week RENU 28, the world's ... became available for purchase in Australia and New Zealand, and ... 28 works is, if you think about the definition of ... cellular renewal within your body. If you think about the ... cellular renewal. What RENU 28 does is it works with ...
(Date:8/20/2014)... succeeded in measuring vibrational motion of a single molecule ... vibration of a single molecule differs from the behaviour ... performed at the University of California, Irvine, where post-doctoral ... as a visiting fellow under professor Vartkess A. Apkarian, ... was lead by Professor Eric O. Potma. The results ...
(Date:8/20/2014)... -- PAREXEL International Corporation (NASDAQ: PRXL ) announced ... Healthcare Conference in New York.  Ingo Bank , ... making a presentation on PAREXEL and discussing business developments ... A live webcast of the discussion will ... at www.PAREXEL.com in the Upcoming Events portion ...
(Date:8/20/2014)... health of your heart, researchers have discovered. , A ... TENS machine like those designed to relieve labour pains ... raised flap at the front of the ear immediately ... changed the influence of the nervous system on the ... failing hearts too hard. , Professor Jim Deuchars, Professor ...
Breaking Biology Technology:RENU 28 Skin Care Now Available in Australia and New Zealand 2Seeing a molecule breathe 2PAREXEL International To Present At Baird Healthcare Conference 2'Tickling' your ear could be good for your heart 2
... Internet routers are the source of problem , ,Madison, ... were infected with the latest e-mail virus last week. At ... 2003, UW-Madison discovered that it was the recipient of a ... one of the campus' public Network Time Protocol (NTP) servers. ...
... The announcement that TechStar will receive a two-year grant ... sign that research institutions in Milwaukee, which for years ... the marketplace, are aspiring to catch up. Thats good ... the Wisconsin economy. , ,If Milwaukee wants to transform ...
... in the field and navigating at the helm of several ... (which is located in Woodridge, Ill. across from Argonne ... advance his drug discovery company. , ,Following a six-month ... the next few weeks with financial adviser Legg Mason ...
Cached Biology Technology:Flawed Routers Flood UW Server 2Flawed Routers Flood UW Server 3Milwaukee research institutions step up the pace for technology transfer 2Advanced Life Sciences to Hit the Road For $30 Million in Funding 2Advanced Life Sciences to Hit the Road For $30 Million in Funding 3Advanced Life Sciences to Hit the Road For $30 Million in Funding 4
(Date:8/20/2014)... The National Institutes of Health has awarded the Oklahoma ... continue its research on anthrax and the bacteria,s effects ... Mark Coggeshall, Ph.D., and his colleagues have studied the ... NIH,s Cooperative Centers for Human Immunology. The original funding ... 17 on the heels of the terrorist attacks of ...
(Date:8/20/2014)... of sunscreen and seawater signals a relaxing trip to ... idyllic beach vacation comes with an environmental hitch. When ... sea, they can become toxic to some of the ... many other marine animals. Their study appears in the ... Antonio Tovar-Sanchez and David Snchez-Quiles point out that other ...
(Date:8/20/2014)... rugs and plastic bags could one day be made ... petroleum, scientists are now reporting. The novel process they ... deal with its agricultural and plastic waste problems, appear ... Athanassiou, Ilker S. Bayer and colleagues at the Italian ... constantly growing. In 2012, its production reached 288 million ...
Breaking Biology News(10 mins):$14.5 million grant awarded to continue anthrax studies 2
... A 3D scan of one of the new catfish ... researchers from Mexico and the United States has identified a ... The paper detailing the discovery has been published in Zootaxa, ... Lacantuniidae and named the species Lacantunia enigmatica. It becomes the ...
... vital passage through a bacterium's outer cell wall will ... the 'wrong' material, scientists at The University of Texas ... has long-term implications for understanding diseases caused by misfolded ... cow disease. , The paper in today's Journal of ...
... of a wide range of physiological and behavioral processes, ... patterns. While it's well known that circadian clock elements ... known about how daily temperature cycles affect the clock's ... PLoS Biology , Kajori Lahiri, Nicholas Foulkes, and ...
Cached Biology News:Researchers identify new catfish family 2Beyond genes: Lipid helps cell wall protein fold into proper shape 2Beyond genes: Lipid helps cell wall protein fold into proper shape 3Temperature regulates circadian clock in zebrafish 2
... been developed for use with immunohistochemical ... nonspecific background staining due to endogenous ... peroxidase with hydrogen peroxide. This ... with additional novel components to further ...
Anti-Human Factor XI Purified (Polyclonal) (sheep IgG)...
Formulation: 10mM PBS/500 mM NaCl, 0.09% NaN3, pH 7.2...
Rad51B...
Biology Products: