Navigation Links
Advanced Life Sciences Announces Restanza(TM) Granted FDA Orphan Drug Designation for Plague and Tularemia
Date:9/15/2009

CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Restanza(TM) (cethromycin), its novel, once daily oral antibiotic, for the prophylactic treatment of plague and tularemia. Both tularemia and plague are classified by the Centers for Disease Control as Category A Bioterrorism Agents, which is the highest priority classification. High-priority agents include organisms that pose a risk to national security because they can be easily disseminated or transmitted, result in high mortality rates and have the potential for major public health impact, might cause public panic and social disruption, and require special action for public health preparedness.

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

Advanced Life Sciences is currently conducting pivotal studies of Restanza under FDA's "Animal Rule" as a broad countermeasure against bioterror agents including plague and tularemia under a contract with the US Department of Defense. Additionally, the Company has previously reported that Restanza demonstrated significant efficacy in preventing anthrax infection post-exposure as well as in treating inhalation anthrax after symptoms of infection had developed.

The Company expects key data to be available and reported from its pivotal animal studies in plague and tularemia by the end of 2009. If these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, Advanced Life Sciences plans to meet with the FDA to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment seeking marketing approval fo
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. Survival differences by race most apparent in advanced stages of breast cancer
2. Patients with Medicaid and those lacking insurance have higher risk of advanced laryngeal cancer
3. Advanced Age No Bar to Liver Transplant
4. Oncologists are critical in managing psychiatric disorders in patients with advanced cancer
5. Advanced technologies aim to transform the coaching of top athletes
6. Mecklenburg EMS Introduces Most-Advanced Situational Training in America for Emergency Medical Personnel
7. Advanced Life Sciences Joins NASDAQ Capital Market
8. Experimental drug shows promise in advanced kidney cancer
9. TCS Healthcare Technologies Announces Full Integration of Case Management Adherence Guidelines into Acuity Advanced Care(TM) System
10. OCuSOFT Refutes Comparison Time-Kill Study Released by Advanced Vision Research
11. U.S. Oncology Initiates Complete Phase Ib Trial of Brostallicin Combination Therapy in Advanced Solid Tumors
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2015)... ... 2015 , ... World Patent Marketing, a vertically integrated manufacturer ... that protects people from crime and other hostile situations. , "The Security Services ... Creative Director of World Patent Marketing. "The industry is growing at a healthy ...
(Date:9/2/2015)... ... September 02, 2015 , ... On September 9, 2015, ... doTERRA’s annual convention, the largest single-company convention to date for the state of Utah. ... forward to a tremendous event,” states David Stirling, doTERRA CEO. “One of the most ...
(Date:9/2/2015)... ... September 02, 2015 , ... Please join the world renowned ... which was established by the Foundation in 2007 with the help of Massachusetts ... more research remains our top priority,” commented Christine Buckley, Executive Director of the ...
(Date:9/2/2015)... ... September 02, 2015 , ... Mobile working is increasingly more important, ... seems that everywhere new mobile apps are being launched, and mobile device usage as ... regular part of their work and personal lives. What's more people are expecting mobile ...
(Date:9/1/2015)... ... September 01, 2015 , ... September is National Prostate Cancer ... affects more than 233,000 men each year in the United States. , Prostate cancer ... non-skin cancer in America, affecting 1 in 7 men. One new case occurs every ...
Breaking Medicine News(10 mins):Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 2Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 3Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 4Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 5Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 6Health News:What Should You Be Watching As You Walk Alone At Night - World Patent Marketing's Hand Free Pocket Cop Invention 7Health News:doTERRA to Host the Largest Single-Company Convention in the State of Utah 2Health News:September Celebrated as Brain Aneurysm Awareness Month 2Health News:New Mobility Experience From Winscribe 2Health News:New Mobility Experience From Winscribe 3Health News:September is Prostate Cancer Awareness Month 2Health News:September is Prostate Cancer Awareness Month 3
... Inc. (NYSE: FRX ) today announced that ... the Company,s supplemental New Drug Application (sNDA) for Lexapro ... Major Depressive Disorder (MDD) in adolescents, 12 - 17 ... to be approved for the treatment of MDD in ...
... Finding could lead to new treatments for cognitive ... News) -- The human brain functions on "the ... order and randomness, according to U.K.-based researchers who ... cognitive performance and psychiatric disorders. , The ...
... 20 CANTEL MEDICAL CORP. (NYSE: ... of the Company, to President and Chief Executive Officer. ... of Directors. Since joining Cantel in September 2004, Mr. Krakauer ... 2008 as President. The Board concurrently appointed Seth R. Segel, ...
... the Migraine Research Foundation (MRF) announced a new initiative ... migraine called FOR OUR CHILDREN. The new program ... understanding of migraine and its causes and treatments in ... , Migraine is very common in children - ...
... SEGUNDO, Calif., March 20 A former astronaut and ... a director of business development for Wyle,s Integrated Science ... Parazynski joins Wyle to assist in the company,s continued ... health and performance services to the Federal Government. He ...
... obscure clinical manifestation of severe vomiting sickness due to ... his colleagues at the Creighton University of Omaha, NE, ... of Gastroenterology . , Recent research into the neurobiology ... receptor types including two specific types that mediate neuropsychiatric ...
Cached Medicine News:Health News:Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents 2Health News:Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents 3Health News:Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents 4Health News:Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents 5Health News:Forest Laboratories, Inc. Announces FDA Approval of Lexapro(R) for the Treatment of Major Depressive Disorder in Adolescents 6Health News:Cantel Medical Corp. Names Andrew Krakauer as CEO and Announces Other Corporate Appointments 2Health News:New initiative to support pediatric migraine research is announced 2Health News:Veteran Astronaut Joins Wyle Business Development Staff in Houston 2
(Date:9/2/2015)... Tumultuous market conditions – including changes in ... activity – have led more than half of today,s ... reps. This marks the first time that the number ... point, according to the spring 2015 AccessMonitor™ report ... . AccessMonitor™ aggregates sales-call records ...
(Date:9/2/2015)... 2015 CytoSorbents Corporation (NASDAQ: CTSO ), ... blood purification technology to reduce deadly uncontrolled inflammation ... Dr. Phillip Chan , MD, PhD, will present ... (sponsored by H.C. Wainwright & Co) taking ... City.  Currently, the management team will ...
(Date:9/2/2015)... , Sept. 2, 2015  OncoSec Medical Incorporated ... intratumoral cancer immunotherapies, announced today that members of its ... events in September, including: , First ... Biology, Medicine and Food & Environmental Technologies; Portoroz, ... 17th Annual Global Investment Conference; New York, ...
Breaking Medicine Technology:Crossing the threshold: More than half of physicians restrict access to sales reps 2Crossing the threshold: More than half of physicians restrict access to sales reps 3Crossing the threshold: More than half of physicians restrict access to sales reps 4Crossing the threshold: More than half of physicians restrict access to sales reps 5CytoSorbents to Present at the 2015 Rodman & Renshaw Annual Global Investment Conference 2CytoSorbents to Present at the 2015 Rodman & Renshaw Annual Global Investment Conference 3CytoSorbents to Present at the 2015 Rodman & Renshaw Annual Global Investment Conference 4OncoSec to Present at Scientific and Investment Conferences in September 2OncoSec to Present at Scientific and Investment Conferences in September 3OncoSec to Present at Scientific and Investment Conferences in September 4OncoSec to Present at Scientific and Investment Conferences in September 5
... Calif., Oct. 21 Bionovo, Inc. (Nasdaq: ... of results from studies discussing new classes of estrogen ... The review is published in the most recent edition ... is entitled, "Regulation of Specific Target Genes and Biological ...
... has granted The Lanier Law Firm ,s motion for a ... cases in In re: DePuy Orthopaedics Inc. ASR Hip Implant ... The United States Judicial Panel on Multidistrict Litigation granted the ... DePuy hip implant litigation for Nov. 18, 2010, at Duke University ...
Cached Medicine Technology:Bionovo Announces Publication Describing Potential Estrogen Receptor Modulating Drugs for Treating Menopausal Conditions 2Bionovo Announces Publication Describing Potential Estrogen Receptor Modulating Drugs for Treating Menopausal Conditions 3Bionovo Announces Publication Describing Potential Estrogen Receptor Modulating Drugs for Treating Menopausal Conditions 4Federal Panel Grants Lanier Law Firm Motion for Hearing on National Coordination of DePuy Hip Implant Lawsuits 2
... the first commercially available real-time detection ... use. , ,The kit can detect ... genotypes of HPV providing the sensitivity ... simplifying the process by using a ...
ACMI™ COAG Bipolar Laparoscopy Probes provide 360 of hemostatis, bipolar safety, blunt dissection, irrigation, and suction in one instrument....
... An in vitro Nucleic ... Amplification using Microplate Chemiluminescence for ... Papillomavirus (HPV) Types 6,11,16,18,31,33,35,39,42,43,44,45,51,52,56,58,59 and ... DNA Lowand High-Risk Groups in ...
An In Vitro Nucleic Acid Hybridization Assay with Signal Amplification using Microplate Chemiluminescence for the Qualitative Detection of Human Papillomavirus (HPV) Types 16, 18, 31, 33, 35, 39, 45,...
Medicine Products: