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Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia 
Shots:  Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia  The alliance will utilize Tabuk's local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities  BAT2206, a proposed biosimilar to…
December 24, 2024
Novo-Nordisk
Novo Nordisk’s Alhemo Receives the US FDA’s Approval as a Prophylactic Treatment of Hemophilia A or B with Inhibitors 
Shots:    The US FDA has approved Alhemo injection (QD) as a prophylactic treatment to reduce the frequency of bleeding episodes in hemophilia A or B patients (≥12yrs.) with inhibitors  Approval was based on the P-III (explorer7) study assessing Alhemo's efficacy and safety by comparing annual bleeding rates (ABR) in patients aged 12+ with hemophilia A…
December 20, 2024
Ionis
Ionis’ Tryngolza (Olezarsen) Receives the US FDA’s Approval to Treat Adults with Familial Chylomicronemia Syndrome (FCS) 
Shots:    The US FDA has approved Tryngolza (80mg, QM, self-administered via an auto-injector) as an adj. for reducing triglycerides (TG) in FCS patients, based on a P-III (BALANCE) study. Further submission is under review in the EU, with more filings planned   The P-III study involved FCS patients with fasting TG levels of ≥880mg/dL. Trial showed…
December 19, 2024
Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara) 
Shots:  Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Janssen's Stelara (Ustekinumab), following CHMP’s positive opinion & FDA's approval  Imuldosa, initially developed by Dong-A Socio Holdings & Meiji Seika Pharma, & was transferred to Dong-A ST in 2020 for global development and commercialization. In 2021, it was out-licensed to Intas Pharmaceuticals for…
December 19, 2024
Xcovery
Xcovery Holdings Receives US FDA Approval for Ensacove (Ensartinib) to Treat ALK-Positive Locally Advanced or Metastatic NSCLC 
Shots:    Xcovery Holdings has received the US FDA’s approval for Ensacove (225mg, oral, QD) for ALK+, locally advanced or metastatic NSCLC in patients not previously treated with ALK-targeted therapy  Approval was based on a global P-III (eXalt3) study assessing ensartinib vs crizotinib in 290 patients, demonstrating significantly improved PFS with mPFS of 25.8 vs 12.7mos.…
December 18, 2024
Celltrion
The US FDA Grants Approval to Celltrion’s Steqeyma (Biosimilar, Stelara) 
Shots:  Celltrion has receive the US FDA’s approval for Steqeyma, biosimilar version of J&J’s Stelara (ustekinumab), to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, & ulcerative colitis  The approval was supported by P-III study in mod. to sev. plaque psoriasis with 1EP as change in the PASI for skin symptoms, showing therapeutic equivalence b/w Steqeyma…
December 17, 2024
Arcturus and Meiji Seika Pharma Report the EMA’s Positive Opinion of Kostaive for COVID-19 
  Shots:     The EMA’s CHMP has granted positive opinion to Kostaive (zepomeran) for active immunization to prevent COVID-19 in subjects of age ≥18yrs.  The EC’s decision on marketing authorization will follow subsequently  Kostaive is a self-amplifying mRNA vaccine that codes for the SARS-CoV-2 spike protein to provide active immunization against COVID-19  Ref: Arcturus Therapeutics and Meiji…
December 16, 2024
Celltrion
Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra)
Shots:  The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity  The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
December 16, 2024
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