Drug Development

Jul 19, 2018
By BioPharm International Editors
FDA and ICH seek comment on new exposure levels for cadmium in drug products.
Jul 17, 2018
By BioPharm International Editors
Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.
Jul 12, 2018
By BioPharm International Editors
The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.
Jul 06, 2018
By BioPharm International Editors
Sanofi will open a R&D operations hub in Chengdu, Sichuan province, China, with a focus on digitalization and big data analysis.
Jul 01, 2018
BioPharm International
Biosimilars and biobetters face developmental challenges to achieving commercialization.
Jul 01, 2018
BioPharm International
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
Jul 01, 2018
BioPharm International
After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.
Jun 26, 2018
By BioPharm International Editors
A new oral delivery method developed by the Harvard John A. Paulson School of Engineering and Applied Sciences could change the way diabetics regulate blood sugar levels.
Jun 25, 2018
By BioPharm International Editors
Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.
Jun 22, 2018
By BioPharm International Editors
The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.
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