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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...
Nov 15, 2024
On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU)...
Nov 14, 2024
On 14 November 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for Samsung Bioepis’ Obodence™ (SB16/denosumab) and Xbryk™ (SB16/denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively....
Nov 14, 2024
On 14 November 2024, Sanofi announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Sarclisa® (isatuximab) in combination with bortezomib, lenalidomide, and...
Nov 14, 2024
On 14 November 2024, Eisai reported that it has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Leqembi® (lecanemab) for use in treating patients with mild cognitive...
Nov 14, 2024
On 14 November 2024, Merck (known as MSD outside the US and Canada) announced that it has entered an exclusive global licence agreement with Shanghai-based LaNova Medicines Ltd to develop, manufacture and commercialise LM-299, LaNova’s investigational PD-1/VEGF...
Nov 14, 2024
On 14 November 2024, GlaxoSmithKline (GSK) announced positive results from a planned interim analysis of the DREAMM-7 head-to-head phase III trial evaluating Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a second-line or...
Nov 14, 2024
On 14 November 2024, UCB announced the presentation of new two-year data from phase 3 studies of Bimzelx® (bimekizumab-bkzx) showing sustained improvements in clinical and patient-reported outcomes in adults with active psoriatic arthritis (PsA) and ankylosing...
Nov 13, 2024
GLP-1 agonists (also known as GLP-1 receptor agonists) represent a class of medications used to treat type 2 diabetes mellitus. Well-known examples of drugs in this class include those manufactured by Novo Nordisk, such as liraglutide (marketed under Victoza® and...
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