08:00 , Jan 21, 2013 |  BC Week In Review  |  Clinical News

American Society of Clinical Oncology (ASCO) regulatory update

ASCO issued a clinical practice guideline to manage neutropenia with fever and prevent related infections in patients with cancer. The guideline for adult patients specifically recommends preventive treatment with antibacterial and antifungal drugs - preferably...
07:00 , Apr 4, 2011 |  BC Week In Review  |  Company News

Dr. Reddy's, GlaxoSmithKline deal

Dr. Reddy completed its previously announced acquisition of GlaxoSmithKline's penicillin manufacturing site in Bristol, Tenn., and U.S. rights to Augmentin amoxicillin/clavulanate and Amoxil amoxicillin. Further terms were not disclosed (see BioCentury, Dec. 6, 2010). Dr. Reddy's...
08:00 , Dec 6, 2010 |  BC Week In Review  |  Company News

Dr. Reddy's, GlaxoSmithKline deal

GlaxoSmithKline will transfer ownership of its penicillin manufacturing site in Bristol, Tenn., and U.S. rights to Augmentin amoxicillin/clavulanate and Amoxil amoxicillin to Dr. Reddy's. GSK will retain ex-U.S. rights for the products. The deal is...
08:00 , Jan 11, 2010 |  BC Week In Review  |  Clinical News

Amoxicillin clavulanate regulatory update

Ranbaxy's Ohm Laboratories Inc. unit received a warning letter from FDA citing certain current good manufacturing practices (cGMP) violations at the company's liquid manufacturing facility in Gloversville, N.Y. The letter was issued based on results...
07:00 , Mar 12, 2009 |  BC Innovations  |  Distillery Therapeutics

Indication: Infectious disease

This week in therapeutics Indication Target/marker/pathway Summary Licensing status Publication and contact information Infectious disease ...
08:00 , Dec 17, 2007 |  BioCentury  |  Finance

Ebb & Flow

Dashing the hopes of buysiders, Biogen Idec (BIIB) said it had not received any definitive offers and would remain independent. The announcement came after market close on Wednesday and BIIB plunged $17.97 (24%) to $57.91...
08:00 , Dec 18, 2006 |  BioCentury  |  Regulation

Political science

Last week's FDA advisory committee meeting on Ketek can only be understood in the context of Sen. Chuck Grassley's ongoing investigation of FDA's approval of Ketek as well as an ongoing review by the Government...
08:00 , Oct 30, 2006 |  BC Week In Review  |  Clinical News

Amoxicillin clavulanate infectious data

Researchers from the Julius Centre for Health Sciences and Primary Care in the Netherlands and colleagues published in The Lancet, a meta-analysis of 6 trials showing that antibiotics seem to be most beneficial in children...
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 |  BC Week In Review  |  Clinical News

Faropenem medoxomil regulatory update

Replidyne Inc. (RDYN), Louisville, Colo.   Forest Laboratories Inc. (FRX), New York, N.Y.   Product: Faropenem medoxomil   Business: Infectious   RDYN received a not approvable letter from FDA for faropenem, an oral penem antibiotic that is partnered with...