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Feb 4, 2024
A study published in Medicina, on 4 February 2024, concluded that Rituximab represents an “efficacious and well-tolerated therapeutic option” for the management of Autoimmune Bullous Diseases (AIBD) and warrants consideration in cases of refractory AIBD.
Feb 2, 2024
Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM), was accepted for review by the European Medicines Agency (EMA). The MAA is supported by data from a...
Feb 1, 2024
Shanghai Henlius Biotech announced its phase 1 clinical study for its denosumab biosimilar of HLX14, which met the primary endpoint. Shanghai Henlius Biotech announced commencement of the study in November 2020. Organon announceda deal in June 2022 for exclusive...
Feb 1, 2024
Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical will co-market SB15, Samsung’s biosimilar of Regeneron’s Eylea® (aflibercept) in Korea. The agreement intends to utilise Samsung’s R&D capabilities with Samil Pharmaceuticals’ sales...
Jan 31, 2024
On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight...
Jan 31, 2024
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 share...
Jan 31, 2024
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...
Jan 31, 2024
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...
Jan 31, 2024
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...
Jan 31, 2024
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...
Jan 31, 2024
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...
Jan 30, 2024
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...
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