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On 18 January 2025, Daiichi Sankyo announced that Daiichi/AstraZeneca’s antibody drug conjugate Datroway® (datopotamab deruxtecan-dlnk) has been approved in the US for treatment of adults with unresectable or metastatic hormone receptor positive HER2 negative breast cancer ...

On 17 January 2025, Novo Nordisk announced results of its Phase 3b trial (STEP UP) of subcutaneous semaglutide 7.2 mg compared with semaglutide 2.4mg and placebo, each administered once weekly.  The results reportedly demonstrate a statistically significant and superior wei...

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibi...

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderatel...

On 15 January 2025, Eli Lilly announced that the US FDA has approved Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active Crohn’s disease in adults.  This follows FDA approval of Omvoh® for ulcerative colitis in October 2023.

In August 2...

On 15 January 2025, Lexaria Bioscience announced that it has received independent ethics board approval to begin its first-ever human study of oral liraglutide, formulated from the DehydraTECH-processing of conventional injected liraglutide (Novo Nordisk’s Saxenda®).