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

9, requires the enrollment of moderate-to-severe CAP patients for approval in the mild-to-moderate CAP indication. Advanced Life Sciences' pivotal Phase 3 program included in the NDA was designed and conducted under prior FDA guidance and before the new draft guidance was released.

Advanced Life Sciences is moving expeditiously to develop a protocol for an additional Phase 3 trial that is designed to satisfy the FDA's request for additional efficacy information. The Company intends to meet with and work closely with the Agency to design and establish a protocol under a Special Protocol Assessment. The company anticipates that initiation of the additional Phase 3 program could take place in the first half of 2010. Advanced Life Sciences is working collaboratively on these clinical plans with Wyeth, its development and commercialization partner in the Asia Pacific region.

"Advanced Life Sciences appreciates the FDA's response to the Restanza NDA and is committed to complying with the Agency's requirements to conduct a clinical program that could lead to approval in CAP," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "We are, however, disappointed that the timing of the new draft CAP guidance issuance had an unfortunate impact on the outcome of our NDA. Looking ahead, we intend to design a study that complies with the new draft CAP guidance and we will work with the Agency to determine the optimal pathway to registration."

Dr. Flavin continued, "We remain encouraged by the supportive comments made by AIDAC committee members in June relative to their positive view 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. We continue to receive strong support from our commercial partner Wyeth and intend to work in close collaboration with them as we implement our clinical program. We
'/>"/>

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

0

GOOD

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:5/17/2013)... (PRWEB) May 17, 2013 •    First of ... Certified for sustainability ,     New facility will help ... , Syngenta unveiled its new crop ... the company’s RTP Innovation Center. The first of its ... to simulate any agricultural climate and precisely measure plant ...
(Date:5/17/2013)... 17, 2013  Cellular Biomedicine Group (OTCQB: CBMG) ... of the total projected enrollment required for its ... preliminary efficacy of the medical technology haMPC (Human ... (KOA). To date the trial has had no ... Phase I open label clinical research trial for ...
(Date:5/17/2013)... Calif. , May 17, 2013 /PRNewswire-iReach/ -- ... has been reached with Switzerland ... of anti-infective human monoclonal antibody (mAb) products, and ... human mAb products for treatment of infections by ... Staphylococcus aureus , Pseudomonas aeruginosa , ...
(Date:5/17/2013)... Men’s skin is biologically different than women’s skin,( says skin ... known to react more aggressively when hormones change, and acne ... other acne causing factors like P.acnes bacteria and excess dirt ... unsightly acne scars. Adult acne treatment, Probiotic Action shares new ... to reduce and prevent acne scarring. , In order to ...
Breaking Biology Technology:Syngenta Opens Unique $72 Million Advanced Crop Lab 2Syngenta Opens Unique $72 Million Advanced Crop Lab 3Cellular Biomedicine Group Achieves 50% Enrollment Milestone in Phase I Clinical Trial for Knee Osteoarthritis 2Aridis Pharmaceuticals Announces Acquisition of Monoclonal Antibody Products and Technologies From Kenta Biotech 2Aridis Pharmaceuticals Announces Acquisition of Monoclonal Antibody Products and Technologies From Kenta Biotech 3Adult Acne Treatment, Probiotic Action Shares New Insight on Why Men’s Skin Scars from Acne and How to Prevent It 2
... Prostate, Lung and Brain Tumor ... Treatment, ... global leader in the field of radiosurgery,today announced key clinical presentation highlights ... in,Scottsdale, Ariz., At this year,s CyberKnife Users, meeting eight presentations reported,on ...
... Feb. 12 AdvanDx announced it has named,Else ... Dako A/S, as Vice,President of Sales and Marketing. ... AdvanDx,s fast, accurate and easy-to-use in vitro,molecular diagnostic ... infectious pathogens. Ms. Trautner previously managed an,organization of ...
... SAN FRANCISCO, Calif., Feb. 12 Rigel,Pharmaceuticals, Inc. (Nasdaq: ... quarter and year ended December 31, 2007., For ... loss of $19.0,million, or $0.61 per share, compared to ... in the fourth quarter of 2006. Weighted average shares,outstanding ...
Cached Biology Technology:CyberKnife Users' Meeting Highlights Major Clinical Data Milestones and Emerging Trends 2CyberKnife Users' Meeting Highlights Major Clinical Data Milestones and Emerging Trends 3CyberKnife Users' Meeting Highlights Major Clinical Data Milestones and Emerging Trends 4Molecular Diagnostics Leader AdvanDx Taps Former Dako Executive Vice President to Lead Global Sales and Marketing Expansion 2Rigel Announces Fourth Quarter and Year End 2007 Financial Results 2Rigel Announces Fourth Quarter and Year End 2007 Financial Results 3Rigel Announces Fourth Quarter and Year End 2007 Financial Results 4
(Date:5/17/2013)... LEMONT, Ill. An international team ... internal structure and cell movement inside a living frog ... showcases a new method to advance biological research and ... at Northwestern University and the Karlsruher Institut fr Technologie ... at the U.S. Department of Energy,s Argonne National Laboratory, ...
(Date:5/16/2013)... a fast food restaurant had a higher body mass ... fast food, according to researchers at The University of ... particularly strong among those with a lower income. ... American Journal of Public Health indicates higher BMI ... and among lower-income African-Americans, the density, or number, of ...
(Date:5/16/2013)... The endothelium, the cellular layer lining the body,s ... few hundred nanometers in thickness, this super-tenuous structure ... tissue compression to create a unique and highly ... partition tissues from the body,s circulatory system. , ... barrier must be physically breached to enable ...
Breaking Biology News(10 mins):New X-ray method shows how frog embryos could help thwart disease 2Body mass index of low income African-Americans linked to proximity of fast food restaurants 2Body mass index of low income African-Americans linked to proximity of fast food restaurants 3Endothelium, heal thyself 2Endothelium, heal thyself 3Endothelium, heal thyself 4
... at Penn State have shed light on some of the processes ... proteins are produced at the correct time, place, and amount in ... evolution of the DNA regions that regulate genes. The team ... are thought to turn on genes that play an important role ...
... Sandcastle worms live in intertidal surf, building sturdy tube-shaped ... natural glue. University of Utah bioengineers have made a synthetic ... used within several years to repair shattered bones in knees, ... of the small pieces together," says Russell Stewart, associate professor ...
... online information system created by D. Ross Robertson, ... and Coeus Knowledge Systems makes it possible for ... managers to identify and generate publishable maps for ... of the Tropical Eastern Pacific Online Information System ...
Cached Biology News:Scientists shed light on evolution of gene regulation 2Scientists shed light on evolution of gene regulation 3Superglue from the sea 2Superglue from the sea 3Superglue from the sea 4Superglue from the sea 5Smithsonian puts tropical Eastern-Pacific shore fishes online 2Smithsonian puts tropical Eastern-Pacific shore fishes online 3
... to Ki67 - Proliferation Marker, prediluted ... related nuclear protein, expressed by proliferating cells ... cycle (G1, S, G2 and M phase). ... Ki67 antibodies are useful in establishing the ...
UBC13 Antibody...
Request Info...
HLA II DG+DR+DP Monoclonal Antibody, Purified, Unconjugated, Clone: IQU9 This antibody is specific for the monomorphic determinant of the HLA Class II beta chains of the human MHC (28 kDa)....
Biology Products: