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CVS Health has launched Cordavis, a subsidiary that will work with manufacturers to commercialise and/or co-produce biosimilars for the US market.  Cordavis has a contract with Sandoz to commercialize and bring to market Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®...

Reuters has reported that Johnson & Johnson’s Janssen will close part of its vaccine research and development programs.  The restructuring was announced in J&J’s Q2 2023 financial results (see page 56), where it notes the R&D program exits are primarily in infec...

Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved in Japan for a new indication: to treat unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.

On 12 J...

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that the EMA has partially approved its phase III IND for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus® to treat multiple sclerosis.  The trial will assess biosimilar...

BMS announced that the European Commission has expanded the indication for its Opdivo® (nivolumab) as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.  Opdivo® is now the only PD-1 inhibitor that ...

The Japan Times has reported that a Ministry of Health, Labour and Welfare (MHLW) committee has recommended approval of Eisai/Biogen’s Leqembi® (lecanemab).  The article notes that the committee’s endorsement will be followed by approval by the Health Minister in the coming...

Regeneron announced that the FDA approved its 8mg Eylea® (aflibercept) to treat Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).  The 8mg dose is the only treatment approved in wAMD and DME for immediate dosing at 8-we...

Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders scheduled for 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz, which includes the planned spin-off effective date of 4 October 2023.

On 18 Ju...

Regeneron announced that the FDA approved its Veopoz®(pozelimab-bbfg) to treat adult and pediatric patients over one year old with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.  CHAPLE is an extremely rare, life-threatening hereditary immune disea...