Cethromycin

U.S. Department of Defense Exercises $2.0 Million Option to Fund Cethromycin Development

- Company Presents Data on Cethromycin Showing In Vivo Efficacy against Tularemia - CHICAGO, March 19 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), a biopharmaceutical company developing cethromycin, a novel once-a-day antibiotic, to treat respiratory tr...

Advanced Life Sciences and Wyeth Sign Commercialization Agreement for Cethromycin in Asia Pacific Region

CHICAGO, Oct. 1 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE ), have signed a development and commercialization agreement for cethromycin in the Asia Pacific region excluding Japan. Cethromycin is a ...

Advanced Life Sciences Announces First Quarter 2009 Financial Results and Financial Outlook

...A advisory committee meeting which will review the cethromycin New Drug Application," said Michael T. Flavin, Ph....pelling rationale for recommending the approval of cethromycin in the treatment of community acquired pneumonia."...the previously announced contract to further study cethromycin as a potential broad-spectrum medical countermeasu...

Advanced Life Sciences Announces Delisting From Nasdaq and Pending Quotation of its Common Stock on the OTC Bulletin Board

...e SEC and is preparing for a major corporate milestone in our upcoming FDA Advisory Committee meeting scheduled for June 2, 2009 to review the NDA for cethromycin as a treatment for community-acquired pneumonia. As we prepare for that event, we look forward to reestablishing the active market for our shares on ...

Advanced Life Sciences Announces Results of Shareholder Meeting and Provides Additional Information on Upcoming Advisory Committee Meeting

...ee will discuss new drug application (NDA) 22-398, cethromycin oral tablets, sponsored by Advanced Life Sciences,...man and CEO of Advanced Life Sciences. About cethromycin In November 2008, the FDA filed the Company's NDA for cethromycin and established a target Prescription Drug User Fe...

Advanced Life Sciences to Present at Susquehanna's Second Annual SIGnificant Investment Options in Healthcare Conference

...ate-stage development for the treatment of respiratory tract infections such as community acquired pneumonia (CAP). In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug fo...

Advanced Life Sciences to Participate in Antibiotics Expert Panel at the 10th Annual BIO CEO & Investor Conference

...ate-stage development for the treatment of respiratory tract infections such as community acquired pneumonia (CAP). In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug fo...

Advanced Life Sciences Completes Private Placement for $20 Million

...ment should allow us to complete the next phase of corporate objectives, including the consummation of a commercial partnership and NDA submission for cethromycin to treat community acquired pneumonia." The shares sold in the private placement have not been registered under the Securities Act of 1933, as amend...

Cethromycin achieves all endpoints in second pivotal Phase III Trial for treatment for pneumonia

...visit was achieved. The study results showed that cethromycin cured 94.0% of patients with CAP, compared to Biax...ation. In the modified intent to treat population, cethromycin cured 83.1% of patients and Biaxin cured 81.1%. cethromycin also demonstrated favorable safety results, with r...

Cethromycin in Medical Technology

Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)

CHICAGO, June 25 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases, today announced that...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

CHICAGO, Sept. 20 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), presented further data in support of cethromycin, the Company's lead compound, at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago, September 17 - 20. A total...

Further Data on Safety and Efficacy of Cethromycin Presented at 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

CHICAGO, Sept. 20 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), presented further data in support of cethromycin, the Company's lead compound, at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago, September 17 - 20. A total...

Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

- Company Will Present Seven Posters and sponsor Satellite Symposium at Key Scientific Gathering at McCormick Place in Chicago, September 17 - 20 - CHICAGO, Sept. 5 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), will present s...

Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents

CHICAGO, Aug. 21 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), today announced the commencement of its collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), the lead governmental institute supporting biodefense research, under...

Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin

-Study Results Show Cethromycin Not Associated with QT Prolongation- -Favorable Cardiac Safety Profile Strengthens NDA- CHICAGO, Feb. 19 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), today announced positive results from Trial CL07-001, a thoroug...

Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia

... - Trial CL-05 Results Showed cethromycin had 94.0% Clinical Cure Rate Compared to 93.8% Cl... visit was achieved. The study results showed that cethromycin cured 94.0% of patients with CAP, compared to Biax...ation. In the modified intent to treat population, cethromycin cured 83.1% of patients and Biaxin cured 81.1%....

Cethromycin Shown Effective Against Anthrax in Study

...from a primate study where a 30-day course of oral cethromycin was 100% protective against a lethal dose of inhal...the treatment of infections such as anthrax." cethromycin was recently granted Orphan Drug designation by th...l efficacy data collected to date, we believe that cethromycin could address this need and be considered for purc...

Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia Clinical Trial

... community acquired pneumonia (CAP). In the study, cethromycin achieved non-inferiority in its primary endpoint o...iaxin(R), both over a seven-day course of therapy. cethromycin also demonstrated safety results that were similar...oupled with the favorable safety profile seen with cethromycin in this study validate our dosing strategy and wil...

Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial

...en the higher clinical cure rate of either cethromycin or Biaxin(R) is 90% or greater. -- The delta ...en the higher clinical cure rate of either cethromycin or Biaxin(R) is between 80% and 90%. In add...not a statistically significant difference between cethromycin and Biaxin(R), which supports non-inferiority. S...

Cethromycin in Biological Technology

Advanced Life Sciences Receives Notice of Planned Cethromycin Review by FDA Advisory Committee

CHICAGO, Feb. 27 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), announced today that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is tentatively scheduled to meet on Jun...

Advanced Life Sciences Announces Cethromycin NDA Accepted for Filing by FDA for the Treatment of Community Acquired Pneumonia

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...

Advanced Life Sciences to Present Data from Selected Cethromycin Clinical Trials at the 45th Annual Meeting of the Infectious Diseases Society of America

- Company to Present Four Posters at Medical Conference in San Diego, October 4 - 7, 2007 - CHICAGO, Oct. 2 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), a biopharmaceutical company engaged in the d...

Advanced Life Sciences Announces Plan to Submit NDA for Cethromycin

CHICAGO, April 10 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS ), today announced that, based on a productive meeting with the U.S. Food and Drug Administration (FDA), the Company plans to submit a New Drug Application (NDA) in the third quarter of 2008 for it...

Advanced Life Sciences Announces 2008 Fourth Quarter and Full Year Financial Results

...(DTRA) contract is indicative of the potential for cethromycin and the significant market opportunity in the biod.... Food and Drug Administration (FDA) for cethromycin in the treatment of mild- to-moderate co... million to fund the advanced development of cethromycin as a potential broad-spectrum medical co...

Advanced Life Sciences Announces Third Quarter 2008 Financial Results

...g agreement that were triggered as a result of the cethromycin new drug application (NDA) submission to the U.S. ...lion, for the development and commercialization of cethromycin with Wyeth in the Asia Pacific region, and completing our cethromycin NDA submission in community acquired pneumonia," s...

Positive Study Results for Ceftaroline Phase III Clinical Study for the Treatment of Complicated Skin and Skin Structure Infections Presented at ICAAC / IDSA

...ic-resistant strains.(2,3) --Activities of ceftaroline, ceftobiprole, and cethromycin against multi-drug-resistant (MDR) Streptococcus pneumoniae isolates from C...at ICAAC / IDSA 2008. 4. Patel SN, McGeer A, Green K,et al. Activities of cethromycin (CETH), ceftaroline (CPT), and ceftobiprole (BPR) against multi-drug resist...

Advanced Life Sciences Announces Second Quarter 2008 Financial Results

...reflects lower development expenses related to the cethromycin pivotal Phase III clinical program, which was comp...ly this quarter to finalize our NDA submission for cethromycin in the community acquired pneumonia indication and...ined in April meetings with FDA to optimize cethromycin NDA for the community acquired pneumonia (CAP) ...

Advanced Life Sciences Awarded U.S. Department of Defense Biodefense Contract Valued at up to $3.8 Million

...tion Agency Will Fund the Advanced Development of cethromycin as a Potential Broad-Spectrum Medical ...rnment contract further validates the potential of cethromycin as a biodefense agent, and it enables us to conduc...tate University stated, "Our initial evaluation of cethromycin against Burkholderia pseudomallei shows that it is...

Advanced Life Sciences Announces Collaboration With UK Ministry of Defence on ALS-886

...halation of chemicals that damage the lung surface. (Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO ) "While we remain focused on our cethromycin partnering and NDA submission activities, we have continued our efforts on the biodefense front. In this regard, we have been pleased to identify addi...