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NEWS

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
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
Checkpoint Therapeutics
Checkpoint Therapeutics’ Unloxcyt (Cosibelimab-ipdl) Receives the US FDA’s Approval for Cutaneous Squamous Cell Carcinoma (cSCC) 
Shots:    Checkpoint has received the US FDA’s approval for Unloxcyt (1,200mg, IV, over 60 minutes, Q3W) to treat metastatic or locally advanced cSCC in adults, ineligible for curative surgery or radiation  Approval was based on the P-I (CK-301-101) trial in solid tumor patients (incl. cSCC: N=109), showing ORR of 48% with mDoR of 17.7mos. in…
December 13, 2024
Galderma
Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis 
   Shots:    The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway   ARCADIA 1 & 2 studies assessed…
December 13, 2024
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