Regulatory

Jun 01, 2016
BioPharm International
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
May 31, 2016
Samsung Bioepis and partner Biogen announced on May 30 that the European Commission approved Flixabi for the treatment of six inflammatory conditions.
May 26, 2016
By BioPharm International Editors
The agency cited Tai Heng Industry with CGMP deviations, including failure to ensure data integrity.
Mar 09, 2016
The five-year Medicare initiative seeks to change the way in which drugs are reimbursed under Medicare Part B.
Feb 12, 2016
FDA cracks down on makers of products extracted from Cannabis and says the products cannot be considered dietary supplements.
Feb 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
Jan 28, 2016
By BioPharm International Editors
On Jan. 27, 2016 FDA announced it plans to review Merck’s investigational antitoxin prevention bezlotoxumab.
Jan 28, 2016
By BioPharm International Editors
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.
Jan 28, 2016
By BioPharm International Editors
Amgen announces FDA will review the company’s BLA for ABP 501.
Jan 14, 2016
BioPharm International
By BioPharm International Editors
Three associated centers in California, New York, and Florida are cited for not following proper sterilization and validation procedures and for not having the appropriate licenses to manufacture a biological drug product.
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