Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Siggi Olafsson has taken the reins at Mallinckrodt after stepping down as Hikma’s CEO. At the same time, Teva has named a new global R&D and chief medical officer while Piramal Pharma Solutions has appointed a fresh COO and Formycon has added to its supervisory board.

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.