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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) whose dise...

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.

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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 dexamethasone (V...

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 impairm...

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 bispecific a...

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 later...

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 spondylitis (...

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 Saxenda®)...

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to da...

On 13 November 2024, BioNTech announced that it has entered a definitive agreement to acquire Biotheus together with global rights to Biotheus’ late-stage clinical asset, BNT327/PM8002, an investigational bispecific antibody targeting PD-L1 and VEGF-A.

Under the agre...