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On 10 July 2024, Novo Nordisk announced that the FDA has issued a Complete Response Letter (CRL) regarding its BLA for once-weekly week insulin icodec for diabetes mellitus.  The CRL is said to include “requests related to the manufacturing process and the type 1 diab...

Novo Nordisk’s Wegovy® (semaglutide) known for treating diabetes, weight loss benefits, and reducing cardiovascular events and kidney disease risks, has been shown in a University of Oxford study, supported by the NIHR Oxford Health Biomedical Research Centre and the Medica...

In a landmark injunction granted on 9 July 2024, the Delhi High Court has temporarily banned Zydus Lifesciences from selling its breast cancer drug SigrimaTM, biosimilar to Roche’s Perjeta® (pertuzumab).  The injunction was ordered in proceedings commenced by Roche earlier ...

Novo Nordisk has reportedly struck a deal with Indonesia’s state-owned pharmaceutical company Bio Farma regarding the packaging of insulin in Indonesia.  This is the first of Novo Nordisk’s packaging deals in Indonesia for insulin, which is manufactured in Denmark and...

A Pfizer-sponsored literature review, published in Expert Opinion on Biological Medicine on 9 July 2024, concluded that there were no unexpected or serious adverse events after patients with IBD switched from Janssen’s Remicade® (infliximab) to an infliximab biosimila...

On 9 July 2024, Regeneron, Mylan, Celltrion and Apotex agreed to the dismissal of Regeneron’s appeals in the US Court of Appeal for the Federal Circuit from PTAB decisions finding US Patent Nos. 9,254,338 and 9,669,069 invalid.  The patents encompass Regeneron’s Eylea® (afl...

On 8 July 2024, Outlook Therapeutics announced that it received marketing authorisation from the UK’s MHRA for its ophthalmic formulation of bevacizumab (ONS-5010, Lytenava™) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for ma...

On 8 July 2024, Just – Evotec, a subsidiary of Evotec SE, announced that it has expanded its partnership with Sandoz to develop and manufacture multiple biosimilars.  The deal was first entered into in May 2023 and is designed to utilise Just – Evotec’s AI driven drug...