Regulatory

Oct 08, 2015
Data protection for biologics is reduced from 12 to five years as a result of the Trans-Pacific Partnership agreement.
Sep 24, 2015
Although the presidential candidate seeks to cap monthly drug costs to $250 for covered drugs, what will happen to drug costs that are associated with co-insurance?
Sep 23, 2015
The presidential candidate teased the introduction of her drug-pricing plan on Twitter a day before she presented the details of her scheme to a community forum in Iowa.
Sep 15, 2015
BioPharm International
Manufacturers challenge details in new policies designed to promote access to important therapies.
Sep 01, 2015
By BioPharm International Editors
The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.
Aug 27, 2015
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
Aug 17, 2015
The company adds a few new arguments—as well as new stakeholder support—to its Citizen Petition on biosimilar naming.
Aug 17, 2015
Challenges related to the reporting of out-of-specification results loom for contract testing laboratories.
Aug 14, 2015
BioPharm International
By BioPharm International Editors
The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.
Aug 12, 2015
FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.
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