On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for...
Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval
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New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa
On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and...
Novo Nordisk Launches Wegovy® in China
On 19 November 2024, Reuters reported that Novo Nordisk has launched Wegovy® (semaglutide) in China. The report...
Supreme Court of India Directs Delhi HC to Reconsider Injunction Against Zydus’ Pertuzumab Biosimilar
On 19 November 2024, the Economic Times reported that the Supreme Court of India has directed the Delhi High Court to...
MSD’s Positive Phase 3 Results for Subcutaneous Pembrolizumab
On 19 November 2024, MSD (Merck in the US and Canada) announced positive topline results from its Phase 3 trial...
Xbrane and Intas to Jointly Develop Nivolumab Biosimilar
On 19 November 2024, Xbrane and Intas announced they have entered an exclusive, global licensing and co-development...
Canada’s Drug Agency Recommends Against Reimbursement of Ebglyss™ (Lebrikizumab)
On 15 November 2024, Canada's Drug Agency (CDA-AMC) published its final recommendation for Eli Lilly’s Ebglyss™...
Regeneron Sues Sanofi For Breach of Dupixent® Collaboration Agreement
Regeneron has sued Sanofi, its partner in the commercialisation of the blockbuster eczema drug Dupixent® (dupilumab),...
Approval Alert: AbbVie’s Elahere® (Mirvetuximab Soravtansine) EU-Approved for Platinum-Resistant Ovarian Cancer
On 18 November 2024, AbbVie announced that European Commission (EC) has approved Elahere® (mirvetuximab soravtansine)...
Celltrion Publishes Additional Phase 3 Study Results Supporting Denosumab and Tocilizumab Biosimilars
In April 2024, we reported that Celltrion presented the 78-week results of its Phase 3 study of CT-P41, biosimilar to...
Amgen Sues Accord and Intas in Fifth US BPCIA Denosumab Patent Suit; Seeks to Consolidate Proceedings
On 13 November 2024, Amgen filed a BPCIA Complaint for Patent Infringement in the US District Court for the Eastern...
Approval Alert: Samsung Bioepis/Biogen’s Aflibercept Biosimilar Approved in EU
On 18 November 2024, Samsung Bioepis and Biogen announced that the European Commission has approved Opuviz™/SB15,...
CHMP Green Light for InflaRx’s Gohibic® (Vilobelimab) & Expanded Indications for MSD, BMS, Janssen, Sanofi & Regeneron
At the November 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)...
Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims Recommended
On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been...
FDA Accepts Regeneron/Sanofi’s Dupixent® (Dupilumab) sBLA Resubmission for Chronic Spontaneous Urticaria
On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted...
Positive CHMP Opinions for Samsung Bioepis’ Denosumab Biosimilars
On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted...