Regulatory

May 20, 2015
Physician confidence in biosimilars and extrapolation of indications are two of the most important factors governing the acceptance and sustainability of biosimilars, say industry panelists.
May 15, 2015
By BioPharm International Editors
Raplixa fibrin sealant, the first approved spray-dried biologic, is a hemostatic agent that helps control bleeding from small blood vessels during surgery.
May 13, 2015
BioPharm International
FDA concludes Orkambi demonstrates a clinical benefit over placebo, but questions the magnitude of the improvement.
May 02, 2015
BioPharm International
The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.
Apr 28, 2015
BioPharm International
By BioPharm International Editors
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
Apr 20, 2015
BioPharm International
By BioPharm International Editors
The European Medicines Agency releases findings from marketing authorization application analysis.
Apr 14, 2015
BioPharm International
By BioPharm International Editors
The European Medicines Agency releases guidelines for addressing and reporting risks associated with medication errors.
Apr 01, 2015
BioPharm International
Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.
Mar 19, 2015
BioPharm International
The bill, originally introduced in 2013, seeks to terminate sequestration to payments for certain drugs and biologicals.
Mar 13, 2015
BioPharm International
Early access to Merck’s Keytruda in the United Kingdom is granted under the UK’s Early Access to Medicines Scheme.
native1_300x100
lorem ipsum