Industry News

Mar 23, 2018
By BioPharm International Editors
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
Mar 21, 2018
By BioPharm International Editors
AbbVie and the International Myeloma Foundation will partner to study the role of a genetic mutation in outcomes of patients with multiple myeloma.
Mar 20, 2018
By BioPharm International Editors
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
Mar 20, 2018
By BioPharm International Editors
ISPE announced BioMarin Pharmaceutical, Shire, Vetter, and Wyeth Pharmaceuticals as FOYA Category winners.
Mar 20, 2018
By BioPharm International Editors
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
Mar 20, 2018
By BioPharm International Editors
The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.
Mar 19, 2018
By BioPharm International Editors
Emerson will provide Ireland’s National Institute of Bioprocessing Research and Training with technologies to help the institute prepare students for the transition to manufacturing digitization in the biopharmaceutical industry.
Mar 16, 2018
By BioPharm International Editors
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
Mar 13, 2018
By BioPharm International Editors
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
Mar 08, 2018
By BioPharm International Editors
GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.
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