Navigation Links
Advanced Life Sciences Announces Outcome of FDA's Anti-Infective Drugs Advisory Committee Review of Restanza(TM) (cethromycin)
Date:6/2/2009

CHICAGO, June 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) announced today that the FDA's Anti-Infective Drugs Advisory Committee voted in the majority that Restanza(TM) (cethromycin) demonstrated safety for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP) (11 positive, 3 negative, 1 abstaining). However, the committee voted that Restanza did not demonstrate efficacy in the treatment of CAP (3 positive, 11 negative, 1 abstaining).

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

"We believe in Restanza's potential and remain committed to its development. We were particularly encouraged by the supportive comments of several members of the committee relative to their positive review of the safety profile of Restanza, the therapeutic need for more effective treatments for CAP and their interest in seeing the company pursue further development," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "As we have throughout the review process we will continue to work closely with the FDA as they complete their assessment of the Restanza new drug application (NDA)."

Although it is not binding, the Committee's recommendation will be considered by the FDA as it completes its review of Restanza's NDA in CAP. The FDA has established a Prescription Drugs User Fee Act (PDUFA) date of July 31, 2009 for the Restanza NDA.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 8:30 a.m. Eastern Time on Wednesday, June 3, 2009 to discuss the outcome of the AIDAC Review.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website '/>"/>

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

0

GOOD

Page: 1 2 3

Related medicine technology :

1. PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)
2. Medivation Announces Positive New Efficacy Data From Phase 1-2 Trial of MDV3100 in Advanced Prostate Cancer Patients
3. Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
4. Entremed Presents Results of ENMD-2076 Phase 1 Study in Advanced Cancer Patients
5. Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
6. Proteolix Presents Phase 1b/2 Clinical Data for Carfilzomib in Advanced Solid Tumor Patients at the 2009 ASCO Annual Meeting
7. Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology
8. Induction Chemotherapy Followed by ChemoRadiotherapy Increased Time-to-Treatment Failure Compared to ChemoRadiotherapy Alone in Patients With Unresectable Locally Advanced Head & Neck Cancer
9. Keryx Biopharmaceuticals Reports Single Agent Phase 2 Data of KRX-0401 (Perifosine) Further Demonstrating KRX-0401s Activity in the Treatment of Advanced Metastatic Renal Cell Cancer
10. New Preliminary Data from Two Studies Show Clinical Activity of Neratinib in Combination with Trastuzumab and in Combination with Paclitaxel in Advanced HER-2 Positive Breast Cancer
11. Celladon Provides MYDICAR(R) Program Update of First-In-Human Trial for Advanced Heart Failure at American Society of Gene Therapy Annual Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... , May 24, 2013 3SBio Inc. ... "Company"), a leading China -based ... marketing biopharmaceutical products, announced today that, at an ... Company,s shareholders voted in favor of the proposal ... and plan of merger dated February 8, 2013, ...
(Date:5/23/2013)... -- Amgen (NASDAQ: AMGN ) will present at ... Thursday, May 30, 2013, at the Westin Boston Waterfront Hotel, ... Daylight Time. Arvind Sood , vice president ... Live audio of the presentation can be accessed from the ... A replay of the webcast will also be available on ...
(Date:5/23/2013)... , May 23, 2013  MGC Diagnostics Corporation ... global medical technology company, today scheduled a conference call ... of fiscal year 2013, ended April 30, 2013. The ... May 30, 2013. The Company will report financial results ... the markets close on Thursday, May 30, 2013. ...
Breaking Medicine Technology:3SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 23SBio Inc. Announces Shareholders' Approval of the Amended Merger Agreement 3MGC Diagnostics Corporation to Report Second Quarter Fiscal 2013 Financial Results on Thursday, May 30, 2013 2
... , ... of Executive Vice President, Commercial Affairs at Microchip Biotechnologies, ... biotech lab systems executive with more than 30 years ... Mr. Goldstein will direct Microchip Biotechnologies, marketing, business development, ...
... , , CAMBRIDGE, Mass. and TOKYO, ... Ltd. announced today the further extension of their research ... increases the collaboration term to seven years and brings ... The companies have been working together since January 2005 ...
Cached Medicine Technology:Howard Goldstein Joins Microchip Biotechnologies, Inc. as Executive Vice President 2Galenea and Otsuka Announce Second Extension to Schizophrenia Research Collaboration 2Galenea and Otsuka Announce Second Extension to Schizophrenia Research Collaboration 3
(Date:5/26/2013)... In the five years through 2013, revenue ... been growing at an average annualized rate of 7.7% to ... in poultry prices as well as output growth, says IBISWorld. ... a healthier alternative to other meats. Additionally, poultry meat represents ... than the world average. And although pork is still the ...
(Date:5/25/2013)... Utah (PRWEB) May 25, 2013 Today, ... health insurance marketplaces . Zane Benefits, which provides comprehensive ... is the leader in defined contribution plans ... website, the October 1, 2013 open enrollment of the ... mantra of the Marketplaces is "Choice, Competition and Clout ...
(Date:5/25/2013)... Imagine running the air conditioner with the windows open ... wasted energy! If the home has a folding pull-down attic ... that may be just what is occurring in the home ... energy in the form of higher energy bills. Drafts are ... home. , Drafts occur through the small cracks around doors, ...
(Date:5/25/2013)... Dr. Leslie Gerstman announced today that Ultherapy ... the neck, on the brow and under the chin -- ... is a non-surgical procedure for the face and neck that ... skin over time. The use of FDA-cleared ultrasound technology enables ... the deepest support layers of the skin – typically addressed ...
(Date:5/25/2013)... Communities of Distinction TV announces ... fifth largest media market in the United States with almost ... destination in Texas and a major convention city. Ft. Worth ... as it is home to many major museums. Both cities ... to the arts. Residents and locals will be able to ...
Breaking Medicine News(10 mins):Health News:Poultry Farming Industry in China Industry Research Report – Now Available from IBISWorld 2Health News:Poultry Farming Industry in China Industry Research Report – Now Available from IBISWorld 3Health News:Zane Benefits Publishes New Information on the Health Insurance Marketplaces 2Health News:Zane Benefits Publishes New Information on the Health Insurance Marketplaces 3Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 2Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 3Health News:How To Stop Drafts and Save On Home Energy Bills This Summer - New Draft Stoppers Now Available From Battic Door Energy Conservation 4Health News:Dr. Leslie Gerstman Is Now Offering the Non-surgical Facelifting Procedure – Ultherapy – in NYC and NJ 2Health News:Communities of Distinction TV Presents May Air Dates for Dallas-Ft. Worth, Texas 2
... DALLAS April 19, 2011 A device developed ... of pelvic fractures with minimal postsurgical scarring, pain and ... the nation,s 200 level I trauma centers. ... Reinert developed the Starr Frame, its associated accessories and ...
... , MONDAY, April 18 (HealthDay News) -- Hospitals are ... not have hemophilia, a rare disorder in which blood does ... patients is potentially risky, according to new research. Stanford ... recombinant factor 7a, grew by 140 times from use in ...
... Gardner HealthDay Reporter , MONDAY, April 18 (HealthDay ... suicide when they live in communities where they feel they ... simply because more same-sex couples live in the area, new ... April 18 in Pediatrics , lesbian, gay and bisexual ...
... 18 (HealthDay News) -- Most people with a reduced sense of ... anything at all -- adjust and learn to cope, researchers say. ... less importance on the sense of smell in their daily lives ... included 470 people, half who either lacked or had a reduced ...
... , MONDAY, April 18 (HealthDay News) -- Healthy ... a type of blood fat associated with heart disease ... scientific statement released Monday. About one-third (31 percent) ... levels, defined as more than 150 milligrams per deciliter ...
... list, can reduce problems with recurring low back pain, reveals ... people suffer with low back pain, and most get better. ... their work, everyday and leisure activities are limited to varying ... is important that the pain be treated at an early ...
Cached Medicine News:Health News:Pelvic-repair device developed by UT Southwestern surgeons enables minimally invasive trauma surgery 2Health News:Pelvic-repair device developed by UT Southwestern surgeons enables minimally invasive trauma surgery 3Health News:Off-Label Use of Clotting Drug Soars, Report Finds 2Health News:Support May Help Curb Suicide Among Gay Youths 2Health News:Support May Help Curb Suicide Among Gay Youths 3Health News:Poor Sense of Smell Not a Big Loss for Most People: Study 2Health News:Lifestyle Changes Can Slash Blood Fat Levels, Experts Say 2Health News:Immediate treatment can alleviate future back problems 2
PremierEdge™ Implant Knives....
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
Interchangeable design allows you to select a single handpiece and change tips during the procedure. Universal connector. Disassembles for easy cleaning. Tips can rotate 360 degrees to re-orient port...
PremierEdge™ Clear Cornea Knives - Trapezoid....
Medicine Products: