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Nov 19, 2024
On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report states that sales will initially be made without insurance subsidy, although Novo Nordisk is investigating mechanisms to reduce costs for Chinese...
Nov 19, 2024
On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to move quickly on reconsidering an injunction, which was reinstated in October 2024, preventing Zydus from manufacturing, selling and marketing...
Nov 19, 2024
On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial evaluating subcutaneous (SC) administration of pembrolizumab, together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy. The SC...
Nov 19, 2024
On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development agreement in relation to Xbrane´s nivolumab biosimilar candidate (referencing BMS’ Opdivo®). The biosimilar will be commercialised through Intas’...
Nov 19, 2024
On 15 November 2024, Canada's Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™ (lebrikizumab), recommending against reimbursement of Ebglyss™ by public drug plans, excluding Quebec, for the treatment of moderate-to-severe atopic...
Nov 18, 2024
Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab), in the US District Court for the Southern District of New York alleging that Sanofi is in breach of its commercialisation agreement. The issues...
Nov 18, 2024
On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube...
Nov 18, 2024
In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to Amgen’s Prolia® (denosumab), and published those results in late July. On 18 November 2024, Celltrion presented additional data from that trial. ...
Nov 18, 2024
On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern District of North Carolina against Accord Biopharma, Accord Healthcare and Intas Pharmaceuticals. The Complaint asserts infringement of 34 of Amgen’s...
Nov 18, 2024
On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept). A positive CHMP opinion was adopted for Opuviz™ in September 2024. Opuviz™ is approved for the...
Nov 15, 2024
At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation under exceptional circumstances for InflaRx’s Gohibic® (vilobelimab) for treatment of adults with...
Nov 15, 2024
On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic...
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