Regulatory

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.
Mar 06, 2015
BioPharm International
In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
Feb 19, 2015
BioPharm International
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
Feb 11, 2015
The industry reacts to the departure of Commissioner Margaret Hamburg.
Feb 09, 2015
BioPharm International
The agency seeks public comment on information collection for biosimilars and interchangeable products.
Feb 04, 2015
BioPharm International
The cyclin-dependent kinase 4/6 inhibitor for the treatment of metastatic breast cancer was approved more than two months ahead of its prescription drug user fee goal date.
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