Regulatory

Mar 29, 2018
By BioPharm International Editors
Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
Mar 29, 2018
By BioPharm International Editors
EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
Mar 19, 2018
By BioPharm International Editors
The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 09, 2018
By BioPharm International Editors
The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).
Mar 07, 2018
By BioPharm International Editors
The agency has approved a new HIV treatment for patients with "limited treatment options".
Mar 01, 2018
BioPharm International
Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.
Mar 01, 2018
BioPharm International
FDA enforcement efforts and drug approvals trend upward.
Feb 06, 2018
By BioPharm International Editors
Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.
Feb 02, 2018
By BioPharm International Editors
The NECC supervisory pharmacist at the center of the 2012 fungal meningitis outbreak was sentenced to 8 years in prison.
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