Navigation Links
Advanced Life Sciences Submits Updated Special Protocol Assessment to FDA for Restanza in Community Acquired Bacterial Pneumonia
Date:6/30/2010

CHICAGO, June 30 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company developing Restanza™, a novel once-a-day oral antibiotic, today announced that it has submitted a final Special Protocol Assessment (SPA) with the FDA for the proposed Phase III clinical program of Restanza in the treatment of patients with community acquired bacterial pneumonia (CABP).  The Company has been engaged in the SPA process with the FDA over the last year and just recently met with officials from the FDA to establish the clinical trial design needed to gain approval in CABP.  As filed, the updated SPA incorporates written and oral comments from the FDA's Division of Anti-Infective and Ophthalmology Products.

(Logo:  http://photos.prnewswire.com/prnh/20080218/ALSLOGO)

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

Michael T. Flavin, Ph.D., Chairman and CEO of Advanced Life Sciences stated, "We would like to thank the FDA for their written comments and guidance during the SPA process.  We have incorporated the Agency's input into our final protocol design and SPA submission for FDA's final review and concurrence.  Based on the FDA's SPA review cycle, we expect a reply to our submission by mid-August of this year.  Reaching an agreement on the SPA will be the next step in the clinical development of Restanza and establish a framework for regulatory approval and commercializa
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. MediPurpose® Announces U.S. Distribution Agreement With Pharmaplast, Egyptian Advanced Wound Care OEM
2. Phase 3 Trial of Nexavar in First-Line Advanced Non-Small Cell Lung Cancer Does Not Meet Primary Endpoint of Overall Survival
3. Syndax Pharmaceuticals Entinostat Shows Clinical Promise in Patients with Advanced Hormone Refractory Breast Cancer
4. Pivotal Phase III Trial of Novartis Drug Afinitor® Met Primary Endpoint in Study of Patients With Advanced Pancreatic Neuroendocrine Tumors
5. New Georgia Advanced Surgery Center Provides Women Many Unique Benefits
6. Advanced Life Sciences Expands Collaboration with U.S. Government to Study Restanza(TM) as Treatment for Sexually Transmitted Infections
7. Lilly Presents New Data in Advanced Melanoma - A Difficult-To-Treat Cancer That Causes Majority of Skin Cancer Deaths
8. Varian Medical Systems Equips Three Leading Cancer Centers in Istanbul with Advanced Radiotherapy Technology
9. AlphaDetail, Inc. Enhances Methodology / Advanced Analytics Capabilities
10. Medical City Hospital Partners With Dallas Fire-Rescue to Outfit First Mobile Units in Dallas County With Advanced EKG Technology
11. Advanced Prostate Cancer Patients Finally Have Another Option
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2014)... 10, 2014  Decision Resources Group finds that ... (ID) specialists are willing to prescribe Durata,s Dalvance ... use as OPAT, approximately two-thirds of the respondents ... their hospital inpatients. However, our findings indicate that ... initiated on OPAT following hospital discharge, and most ...
(Date:7/10/2014)... July 10, 2014 CVS Caremark Corporation (NYSE: ... has approved a quarterly dividend of $0.275 (27.5 cents) per ... on August 1, 2014, to holders of record on July ... CVS Caremark is dedicated to helping people on their path ... the United States . Through the company,s ...
(Date:1/15/2014)... Jan. 15, 2014 Sono-Tek Corporation (OTC BB: SOTK) today ... 30, 2013, compared to sales of $2,202,000 for the prior ... this quarter has also shown growth over the preceding quarter,s ... of this fiscal year. Markets that experienced sales increases over ...
Breaking Medicine Technology:Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 2Long-Acting Antibiotics Offering Once-Weekly Dosing Will See Favorable Uptake and Use as Outpatient Parenteral Antimicrobial Therapy (OPAT) 3Sono-Tek Announces Third Quarter Results 2Sono-Tek Announces Third Quarter Results 3Sono-Tek Announces Third Quarter Results 4
... Mass., Jan. 4, 2012  Halo Therapeutics, LLC, a ... fibrotic diseases, today announced that the United States ... designation for HT-100 for treatment of Duchenne muscular ... neuromuscular disorder, which afflicts approximately 1 in 3,500 ...
... Pa., Jan. 4, 2012  Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) ... 30th Annual J.P. Morgan Healthcare Conference to be held ... in San Francisco, CA.  Mr. Adrian Adams, Chief Executive ... of the Company and its product pipeline at 2:00 ...
Cached Medicine Technology:Halo Therapeutics' HT-100 Receives FDA's Orphan Designation for Duchenne Muscular Dystrophy 2Halo Therapeutics' HT-100 Receives FDA's Orphan Designation for Duchenne Muscular Dystrophy 3Auxilium Pharmaceuticals to Present at the 30th Annual J.P. Morgan Healthcare Conference 2Auxilium Pharmaceuticals to Present at the 30th Annual J.P. Morgan Healthcare Conference 3Auxilium Pharmaceuticals to Present at the 30th Annual J.P. Morgan Healthcare Conference 4
(Date:7/12/2014)... it doesn't matter what your budget is, the trendy wedding ... affordable gown can visit Discount-Dress.com (a reliable online ... items. Recently, the company has announced its new selection of ... it is also providing great discounts for these unique items. ... this promotion is July 29, 2014. , Discount-Dress.com is ...
(Date:7/11/2014)... July 12, 2014 Recently, DressyQuinceanera.com, a ... Quinceanera Dama dresses to its online category. ... are offered at deeply discounted rates, up to 62% ... DressyQuinceanera.com are equally excellent in terms of quality and ... handmade. Similar discounts are also offered for the company’s ...
(Date:7/11/2014)... 12, 2014 According to new ... market is expected to register a CAGR of ... Browse 71 market data tables and 76 figures ... "C4ISR Market"., http://www.marketsandmarkets.com/Market-Reports/c4isr-market-1315.html , Early buyers ... http://www.marketsandmarkets.com/requestCustomization.asp?id=1315 , The report provides market analysis ...
(Date:7/11/2014)... (PRWEB) July 11, 2014 As ... filed against Johnson & Johnson’s Ethicon Inc. unit ... LLP notes that the Texas Attorney General’s Office ... marketing of surgical mesh products used to treat ... to a report from kens5.com, the probe began ...
(Date:7/11/2014)... (HealthDay News) -- Reducing the number of deer in ... disease and other tick-borne infections among people, new research ... be manipulated to reduce human interactions with deer, infected ... the researchers wrote. White-tailed deer are the primary ... to people. The study included nearly all the ...
Breaking Medicine News(10 mins):Health News:Worldwide Brides-to-be: It Is Time To Show Your Beauty By Wearing A Trendy Summer Short Wedding Dress From Discount-Dress.com 2Health News:DressyQuinceanera.com: Beautiful Quinceanera Dama Dresses At Low Prices 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 2Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 3Health News:C4ISR Market Estimated to Reach $93.04 Billion by 2019 - New Report by MarketsandMarkets 4Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 2Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 3Health News:Transvaginal Mesh Lawsuit News: Bernstein Liebhard LLP Notes Report of Texas Probe into Ethicon Pelvic Mesh Marketing 4
... of ... action, PRINCETON, ... provider of advanced wound care products,announced today that the most recent study ... associated with a,reduction in wound size, possibly driven in part by a ...
... Administrative Cost Savings for Harvard Pilgrim Over the Life of the ... ... Perot Systems,Corporation (NYSE: PER ) and Harvard Pilgrim Health Care ... 2021., Under this new 13-year, $1 billion contract, Harvard Pilgrim will,realize ...
... actively-used PHR in the market, OAKLAND, Calif., April ... 2 million members are actively using the personal,health record ... find,Kaiser Permanente,s personal health record an effective way to ... are finding it difficult to attract,users, Kaiser Permanente has ...
... MONTVALE, N.J., April 8, 2008 Protection against,vaccine-preventable ... need protection. To make clinicians aware of the ... patients, The Journal of,Family Practice has published a ... diseases: Are adults in your community adequately,protected?, ...
... BOSTON, April 8, 2008 The March of ... & Moving,of Canton will serve as a statewide corporate ... WalkAmerica, March for Babies is the,March of Dimes premier ... as well as those who need help to survive ...
... demonstration project will test effectiveness of health,management ... chronic illness in the,Medicare population, MINNEAPOLIS, ... HFIT) announced today it is working with ... Pfizer Inc., as part of a,three-year Senior ...
Cached Medicine News:Health News:New Study Shows the Use of MEDIHONEY(TM) Wound & Burn Dressing is Associated With Reduction in Wound Size 2Health News:New Study Shows the Use of MEDIHONEY(TM) Wound & Burn Dressing is Associated With Reduction in Wound Size 3Health News:New Study Shows the Use of MEDIHONEY(TM) Wound & Burn Dressing is Associated With Reduction in Wound Size 4Health News:Perot Systems and Harvard Pilgrim Extend IT and Business Process Service Relationship 2Health News:Perot Systems and Harvard Pilgrim Extend IT and Business Process Service Relationship 3Health News:Perot Systems and Harvard Pilgrim Extend IT and Business Process Service Relationship 4Health News:Two Million People Using Kaiser Permanente's Personal Health Record 2Health News:Adults Need Protection Against Vaccine-Preventable Diseases, Too 2Health News:Humboldt Storage & Moving to Partner with March for Babies 2Health News:Humboldt Storage & Moving to Partner with March for Babies 3Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 2Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 3Health News:HealthFitness Teams with Pfizer Health Solutions to Implement CMS Senior Risk Reduction Demonstration Project 4
... includes three major components: Blood pump, Cannulae, ... Driver. This system provides partial or total ... conventional therapy, is unable to maintain adequate ... support, blood flows from the natural heart ...
Datascope presents a unique new product for post-hemostasis puncture site management. Safeguard is the first product ever to combine a built-in inflatable bulb and a sterile dressing- providing adjus...
... catheter is inserted into the subclavian or ... vena cava. The Cool Line incorporates ... temperature-controlled saline flowing within a closed-loop design, ... circulation. The Cool Line combines two ...
... The Fortius catheter provides maximum ... to target temperature. The Fortius catheter ... design to provide the ultimate solution ... catheter is inserted percutaneously into the ...
Medicine Products: