08:00 , Jan 2, 2012 |  BC Week In Review  |  Company News

Covis, GlaxoSmithKline sales and marketing update

GlaxoSmithKline granted Covis U.S. and Puerto Rican rights to commercialize antibiotics Fortaz ceftazidime and Zinacef cefuroxime, cardiovascular drug Lanoxin digoxin, depression drug Parnate tranylcypromine sulfate and gastrointestinal drug Zantac Injection ranitidine...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

The ABS comparisons

The ABS comparisons Study Treatment Clinical cure rate at TOC visit in clinically evaluable population Lower limit 95% CI (A) Clinical cure rate at TOC visit in ITT population Lower limit 95% CI (A) 100288...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

Up next

Up next Company Product Description Indication Status Primary endpoint (Ph III) Advanced Life Sciences Cethromycin Ketolide antibiotic CAP (A) Ph III (CAP) Non-inferiority to clarithromycin GlaxoSmithKline Altabax retapamulin Topical pleuromutilin antibiotic SSSI PDUFA date...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

On the market

On the market Product Class Amoxil amoxicillin (GlaxoSmithKline) Beta-lactam Augmentin amoxicillin/clavulanate (GlaxoSmithKline) Beta-lactam Omnicef cefdinir (Abbott) Beta-lactam Ceftin cefuroxime (GlaxoSmithKline) Beta-lactam Cefzil cefprozil (Bristol-Myers) Beta-lactam Vantin cefpodoxime (Pfizer) Beta-lactam Avelox moxifloxacin (Bayer) Fluoroquinolone Cipro ciprofloxacin...
08:00 , Oct 30, 2006 |  BioCentury  |  Regulation

Antibiotic resistance

FDA's rejection of Replidyne Inc.'s faropenem medoxomil has removed nearly all doubt the agency has resolved a long-running internal debate over the acceptability of non-inferiority studies to support efficacy in most community-acquired bacterial infections. But...
07:00 , Sep 18, 2006 |  BioCentury  |  Product Development

Non-inferiority in ABS

Non-inferiority in ABS Company Product Endpoint supporting approval Timing of measurements Status Beta Lactam Replidyne/Forest Orapem (Faropenem) medoxomil Non-inferiority comparison w/ cefuroxime axetil (A) Test of cure visit (days post-treatment N/A) Oct. 20 PDUFA Macrolide...
07:00 , Jun 12, 2006 |  BC Week In Review  |  Clinical News

Ketek telithromycin: Phase III suspended enrollment

SAN said it voluntarily suspended enrollment in a pediatric trial for Ketek to await FDA confirmation that the development program is consistent with the agency’s "current thinking" on development of anti-infectives in children. A double-blind,...
07:00 , Oct 17, 2005 |  BC Week In Review  |  Clinical News

Factive gemifloxacin mesylate: Phase III data

In a retrospective analysis of 4 Phase III trials in 1,969 patients, Factive was more effective than cefuroxime and trovafloxacin. In the 301 patients with allergic rhinitis, response rates were 89.3% for Factive vs. 77%...
07:00 , Oct 17, 2005 |  BC Week In Review  |  Clinical News

Factive gemifloxacin mesylate: Phase III data

Data from a retrospective analysis of 10 Phase III trials in 5,378 patients showed that Factive was similar to comparators at the end of therapy with success rates of about 90%. Factive was more effective...
08:00 , Nov 3, 2003 |  BioCentury  |  Strategy

Ranbaxy's top sellers

Ranbaxy's top sellers Product Therapeutic area 2002 sales Axetil cefuroxime Anti-infectives $115.0 Mox/Ranoxyl amoxicillin Anti-infectives $45.5 Sporidex cephalexin Anti-infectives $44.3 ...