News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
Biotech company MedGenesis Therapeutix has granted Pfizer an exclusive, worldwide option to license its glial cell line-derived neurotrophic factor (GDNF) protein and convection enhanced delivery (CED) technology to be used in research for potential...
Genzyme has filed a patent application for a technology platform that will bridge the gap between upstream and downstream processing in continuous biomanufacturing.
Merck Serono is planning to invest between €130m ($168m) and €150m ($194m) in biosimilars in 2015, depending on the outcome of ongoing Phase I studies, the company announced Thursday.
update #2 - Regeneron to appeal
European authorities have revoked a Regeneron patent covering a genetic modification technique used to generate mouse monoclonal antibody (mAb) production platforms after an appeal by several European firms.
Citing “insufficient” labelling for biosimilars “given their unique scientific and regulatory status,” EuropaBio is calling on the EMA (European Medicines Agency) to amend their labelling requirements.