Industry News

Sep 25, 2017
By BioPharm International Editors
FDA participated in a global operation to combat the sale and distribution of unapproved and illegal drugs.
Sep 25, 2017
Biopharmaceutical companies developing new competitive biotech therapies have pressed hard for clarity on the testing and data required by FDA to gain market approval of biosimilars that can be filled by a pharmacist without prescriber preapproval.
Sep 25, 2017
By BioPharm International Editors
Keynote speakers for ISPE’s 2017 Annual Meeting & Expo include representatives from AstraZeneca and GSK.
Sep 22, 2017
By BioPharm International Editors
Winners for each category will be revealed at the CPhI Pharma Awards Gala, taking place on Oct. 24, 2017.
Sep 21, 2017
By BioPharm International Editors
The agency sent out 13 warning letters on Sept. 19, 2017 to companies selling drug products online.
Sep 20, 2017
By BioPharm International Editors
Under this partnership, Johnson & Johnson and BARDA will focus on the advanced development of a small-molecule drug and vaccine for the pandemic flu.
Sep 19, 2017
By BioPharm International Editors
Validation and batch testing failures were among the violations found by the FDA at the company’s Jiangsu facility.
Sep 19, 2017
By BioPharm International Editors
The collaboration with Immunocore, a T cell receptor company, aims to discover and develop immunotherapy molecules to treat infectious diseases.
Sep 15, 2017
Continued industry investment in advanced biologics will raise further regulatory challenges and require innovative manufacturing systems.
Sep 14, 2017
By BioPharm International Editors
The agency will offer $35 million in funding over the next five years, on research that aims to modernize manufacturing and quality assurance and control (QA and QC) practices.
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