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Novo Nordisk announced in its 2023 Annual Report that it has increased sales by 31% to DKK 232.3B in 2023, and increased its operating profit by 37% in Danish Kroner.  Key developments outlined in the Report include:

a 51% net profit increase and 49% increase in sh...

Outlook Therapeutics announced that it has dosed the first subject in its clinical trial (NORSE EIGHT) which aims to evaluate the effect of ophthalmic formulation of bevacizumab (ONS-5010), in patients suffering from neovascular age-related macular degeneration (wet AMD).

Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS).  Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen...

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”.  Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the cur...

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with MSD’s Keytruda® (pembrolizumab (genetical recombination)) as a combination thera...

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis’ SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiv...

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidat...

On 24 January 2024 New Zealand introduced a new IP Bill for Geographical Indications (GIs).
The bill will amend NZ law to implement aspects of the Free Trade Agreement with the European Union signed in Brussels on 9 July 2023 by providing for the registration of Europ...

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemist...

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared t...