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news.GSK revises US Avandia label to include FDA usage restrictions
The new labels now carry US prescribed information on medication guides, additional safety and restrictions on the use of these medicines for cardiovascular event data in type 2
The new labels now carry US prescribed information on medication guides, additional safety and restrictions on the use of these medicines for cardiovascular event data in type 2
The joint agreement resolves all legal disputes between the two companies, including those relating to UCB’s pegylated humanized antibody fragment, Cimzia (certolizumab pegol), and PDL’s Queen et al.
Vical is collaborating with the university’s School of Medicine and the Sealy Center for Vaccine Development under a previously disclosed grant on the preclinical development of an HSV-2
Boehringer Ingelheim will carry out the technical development, clinical manufacturing and all related regulatory filing support services for antibodies discovered by Elan. Elan will guide the discovery science,
POTELLIGENT CHOK1SV is a new host cell line for manufacturing recombinant antibodies. It combines the power of BioWa’s engineered glycosylation POTELLIGENT Technology with the advantages of Lonza’s proprietary
The trial is designed to evaluate multiple objective efficacy measures in order to support the design of the Phase 3 clinical studies. The randomised, double blind, Phase 2b
Elesclomol is a first-in-class investigational drug candidate that triggers programmed cell death in cancer cells by targeting mitochondrial energy production in cancer cells. The trial, which will enroll
The NON outlined Health Canada’s concerns, which are focused mainly on chemistry, manufacturing, and control (CMC) and preclinical toxicology issues. Health Canada has requested additional information on polyglucose
Annual non-GAAP net income and non-GAAP EPS was $4.1bn and $4.54, up 36% and 35%, respectively, compared to 2009. For the fourth quarter, non-GAAP net income and non-GAAP
The Redcar-based firm intends to use the funds to accelerate the development of a pioneering probe that monitors bio-processes using cells, or parts of them to make medicines