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Latest Macrolide antibiotics Stories

2010-03-11 06:30:00

CHICAGO, March 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today that the U.S. Food and Drug Administration (FDA) has provided guidance on the clinical program required to assess the approvability of Restanza(TM) (cethromycin), a novel oral once-a-day...

2009-10-29 11:00:00

CHENGDU, China, Oct. 29 /PRNewswire-Asia-FirstCall/ -- Tianyin Pharmaceutical, Co., Inc., (NYSE Alternext: TPI), a manufacturer and supplier of modernized traditional Chinese medicine ("TCM") based in Chengdu, China, today announced it has formed a joint venture with Sichuan Mingxin Pharmaceutical Co., Ltd ("Mingxin") named Sichuan Jiangchuan Pharmaceutical Co., Ltd. ("Jiangchuan"). Tianyin owns 77% of Jiangchuan and will utilize this as the foundation for a broader, longer term strategy...

2009-06-02 16:41:00

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...

2009-05-29 09:31:00

CHICAGO, May 29 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the June 2, 2009 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. At the meeting, the AIDAC will review and discuss Advanced Life Sciences' New Drug Application (NDA) for Restanza(TM) (cethromycin) in the proposed indication of outpatient treatment of adults with...

2008-12-03 11:04:00

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 of mild-to-moderate community acquired pneumonia (CAP). The FDA has established a goal of a standard 10-month review such that the anticipated target action date of the cethromycin NDA would be...

2008-11-27 09:13:12

Long-term use of an antibiotic may reduce the frequency of exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD), but the threat of growing antibiotic resistance may affect those encouraging results. In the first study of its kind, researchers followed 109 patients with moderate to severe COPD for a year after randomly assigning them to receive either a placebo or a twice daily 250 mg dose of erythromycin. The patients recorded their exacerbations and...

2008-10-01 12:00:31

Cempra Pharmaceuticals and Biovista have signed a research agreement to systematically identify and profile adverse event associations for members of the macrolide drug class. The data generated will be used to better understand the unique benefit/risk characteristics of this important group of antimicrobial drugs, thereby helping to adapt and optimize future clinical trial designs, said Cempra. Cempra's macrolide in development, CEM-101, has recently completed a Phase I study. In...

2008-09-30 09:01:00

Cempra Pharmaceuticals, Inc., and Biovista, Inc., announced today that they have entered into a research agreement to systematically identify and profile adverse event associations for members of the macrolide drug class. The data generated will be used to better understand the unique benefit/risk characteristics of this important group of antimicrobial drugs, thereby helping to adapt and optimize future clinical trial designs. "This collaboration with Biovista is a significant step forward...

2007-02-16 09:01:11

InSite Vision Incorporated (AMEX:ISV) today announced the signing of a licensing agreement with Inspire Pharmaceuticals (NASDAQ:ISPH) for the United States and Canada. The agreement provides for the commercialization by Inspire of AzaSite™ (1% azithromycin), InSite's topical anti-infective product currently under NDA review by the FDA for the treatment of bacterial conjunctivitis; commonly referred to as "pink eye". The global market...

2006-06-29 17:27:22

By Lisa Richwine WASHINGTON (Reuters) - Sanofi-Aventis put a stronger warning on its antibiotic Ketek following the deaths of four patients who took the drug and developed liver failure, U.S. regulators said on Thursday. Liver failure also was reported in eight other Ketek users, including one who needed a liver transplant, the Food and Drug Administration said. Twenty-three others developed less serious liver damage, the FDA said. FDA officials said the liver problems were rare and...


Word of the Day
kenspeckle
  • Having so marked an appearance as easily to be recognized.
This word may come from the Swedish 'kanspak,' quick at recognizing persons or things, or else from confusion with 'conspicuous.'