Regulatory

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.
Jan 08, 2016
By BioPharm International Editors
A US district judge entered a consent decree of permanent injunction on behalf of FDA, between the United States and pharmaceutical company, Downing Labs.
Jan 01, 2016
BioPharm International
Traceability and transparency will remain elusive if manufacturers continue to approach serialization projects on a case-by-case basis.
Dec 10, 2015
By BioPharm International Editors
Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.
Dec 08, 2015
By BioPharm International Editors
FDA approves Kanuma, the first treatment for patients with lysosomal acid lipase.
Dec 07, 2015
While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.
native1_300x100
lorem ipsum