Navigation Links
Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for the Treatment of Community Acquired Pneumonia
Date:12/3/2008

CHICAGO, Dec. 3 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the Company's New Drug Application (NDA) for cethromycin, a novel once-a-day oral antibiotic, for the treatment of mild-to-moderate community acquired pneumonia (CAP). The FDA has established a goal of a standard 10-month review such that the anticipated target action date of the cethromycin NDA would be July 31, 2009.

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

"We will work closely with the FDA to facilitate its review of our NDA for cethromycin," said Michael T. Flavin, Ph.D., the Company's chairman and chief executive officer. "We are excited about the possibility of bringing cethromycin forward to the market as an attractive new oral antibiotic option for physicians to treat mild-to-moderate CAP."

The cethromycin NDA is based on a full clinical development and manufacturing program for cethromycin. The program included two global Phase III pivotal studies for the treatment of mild-to-moderate CAP in which cethromycin was dosed orally at 300 milligrams once daily for seven days compared to the standard of care therapy, Biaxin(R), which was dosed orally at 250 milligrams twice daily for seven days. The data from these trials showed that cethromycin was non-inferior to Biaxin with a similar safety profile.

More than 5,000 patients have been treated with cethromycin in 53 clinical trials to date.

About Community Acquired Pneumonia (CAP)

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptoco
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Advanced Technologies and Wireless Telecommunications Enhance Care and Medical Training at the Ryder Trauma Center in Miami
2. Imaging Diagnostic Systems is Recognized for Its Advanced Engineering in Time-Resolved Techniques by the US Patent Office
3. Advanced Life Sciences Announces Third Quarter 2008 Financial Results
4. Global Med Technologies(R), Inc. Partners With Biomedical Synergies to Offer Advanced Tissue Tracking Solutions for Hospitals and Surgery Centers
5. Advanced Viral Announces Phase IIb Wound Healing Trial for AVR123
6. Advanced Life Sciences Completes Debt Transaction
7. New Clinical Studies Presented at the American Society of Anesthesiology (ASA) Annual Meeting Show Masimo Technologies Provide Advanced Clinical Intelligence
8. Solos Endoscopy, Inc. Applauds American College of Surgeons Review of Advanced Breast Cancer Detection at 94th Annual Clinical Congress
9. Advanced Life Sciences Announces Presentations at Fall Scientific and Investor Conferences and Third Quarter 2008 Earnings Conference Call
10. Peregrine Pharmaceuticals Reports Progress in Its Phase II Trial of Bavituximab Plus Docetaxel in Patients With Advanced Breast Cancer
11. McMaster University unveils worlds most advanced microscope
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/1/2015)... , ... July 01, 2015 , ... It is now ... (TBI) using single photon emission computed tomography (SPECT) according to researchers from ... which examined over 20,000 brain scans and is believed to be the largest brain ...
(Date:7/1/2015)... ALTO, Calif. , July 1, 2015 /PRNewswire/ ... focused on the development of groundbreaking drugs to ... (ALS), announced today that Robert G. Miller ... Center at Sutter Health,s California Pacific Medical Center ... The ALS Association for $1.5 million to help ...
(Date:7/1/2015)... IN (PRWEB) , ... July 01, 2015 , ... Apex ... 2015 BIO International Convention in Philadelphia, PA. , The presentation took place ... and outlined the plans for the development of APX3330 for the treatment of pancreatic ...
(Date:6/30/2015)... , June 30, 2015 /PRNewswire/ - Resverlogix ... of common shares of Resverlogix have approved the ... Eastern Capital Limited of 5,600,000 units at a ... Placement"), each unit being comprised of one common ... aggregate proceeds of approximately CAD$15 million; and (ii) ...
Breaking Biology Technology:Brain Scans Can Tell Post-Traumatic Stress Disorder and Traumatic Brain Injury Apart According to New Research by Amen Clinics 2Brain Scans Can Tell Post-Traumatic Stress Disorder and Traumatic Brain Injury Apart According to New Research by Amen Clinics 3Brain Scans Can Tell Post-Traumatic Stress Disorder and Traumatic Brain Injury Apart According to New Research by Amen Clinics 4Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 2Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 3Investigator to Receive $1.5 Million Grant from the ALS Association to Help Fund Confirmatory Phase 2 Study of Neuraltus Pharmaceuticals' NP001 4Apex Therapeutics Presented Company Overview at This Year’s BIO International Convention in Philadelphia, PA 2Resverlogix Corp. Shareholders Approve Matters Relating to Licensing and Equity Arrangement 2Resverlogix Corp. Shareholders Approve Matters Relating to Licensing and Equity Arrangement 3
... Peru , expansion of Argentina ... development timelines for biopharmaceutical companies - PRINCETON, N.J., April 7 ... the recent opening of new clinical development offices in Santiago, ... Buenos Aires, Argentina office. These latest office openings further ...
... is chosen as a finalist in the International Bio 2009 Convention ... ... DE (PRWEB) April 7, 2009 -- Impact Systems Inc., ( www.ImpactSystems.com ... and services, today announced their Compliance-in-a-Box video has been selected as ...
... The following release is being issued by ... http://www.newscom.com/cgi-bin/prnh/20090325/DC89081LOGO ) WHAT: ... of medical science and discovery in the United ... to maintaining America,s leadership in medical innovation. ...
Cached Biology Technology:Covance Opens New Clinical Development Offices in Chile, Peru and Expands Argentina Office 2Covance Opens New Clinical Development Offices in Chile, Peru and Expands Argentina Office 3Impact Systems' Compliance-in-a-Box™ Video is Announced as "Be the Buzz of Bio" Contest Finalist 2Impact Systems' Compliance-in-a-Box™ Video is Announced as "Be the Buzz of Bio" Contest Finalist 3Council for American Medical Innovation Brings U.S. Leaders in Medicine, Biotechnology and Discovery Together in Chicago for 'Best and Brightest Forum on Medical Innovation' 2
(Date:6/24/2015)... , June 24, 2015  Synaptics Inc. (NASDAQ: ... interface solutions, today announced that Sharp has selected ... secure authentication for its latest flagship smartphone device, ... than 200 million shipments of its fingerprint ID ... Synaptics, strength, scalability and leadership in the biometrics ...
(Date:6/23/2015)... 2015 Research and ... the "Body-Worn Temperature Sensors Market - Global ... 2014 - 2020" report to their offering. ... the global body-worn temperature sensors market. The global ... the basis of types, care setting, patient demographic, ...
(Date:6/18/2015)... June 18, 2015 NXT-ID, Inc. (NASDAQ: NXTD ... on the growing mobile commerce market announces that its Wocket® ... on "Money on the Mark", scheduled to air on WABC ... June 20 th . The broadcast air- ... 7:00 to 8:00pm EST. NXT-ID, Inc.,s CEO Gino Pereira ...
Breaking Biology News(10 mins):Synaptics Brings Natural ID Technology to Sharp's Newest Flagship Smartphone 2Body-Worn Temperature Sensors Market - Global Industry Analysis 2NXT-ID, Inc.'s CEO Gino Pereira Talks About the Wocket Smart Wallet on WABC Radio, New York City, June 20th 2NXT-ID, Inc.'s CEO Gino Pereira Talks About the Wocket Smart Wallet on WABC Radio, New York City, June 20th 3
... most important causes of Alzheimer,s disease. Passive immunization of ... performance in various Alzheimer,s disease animal models or patients. ... library is an effective and quick method to obtain ... Neural Regeneration Research (Vol. 8, No. 33, ...
... of view, the world,s most exotic sex lives may be ... full of surprises, and a new one reported in the ... of those who study the evolution of mating and ploidy, ... is a seemingly anything goes world. Individual yeasts reserve the ...
... Nearctic deposited in the United States National Museum of ... Collection of Insects, researchers have found 16 new species ... seven new species. The new species are described ... Species, and a Key of the Charipinae (Hymenoptera: Cynipoidea: ...
Cached Biology News:Yeast's lifestyle couples mating with meiosis 2Yeast's lifestyle couples mating with meiosis 3
A431 cells Source: Cell Lysate Form: Ready to Use Application: Western Blotting Control...
A431 cells stimulated with EGF Source: Cell Lysate Form: Ready to Use Application: Western Blotting Control...
... 9001:2000 Certified USDA Research Registered OLAW Assured ... Training AALAS Certified Technicians Documentation ... Documentation Upon Request Focus CRP ... all your custom immunology service needs. ...
... and automation that is controlled from within Excel. ... , Pre-configured library of interfaces for balances, scales ... added and configured by the user ... spreadsheet , Allows for multi-tasking during ...
Biology Products: