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Celltrion
NEWS

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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NEWS

Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance

Shots: Bio-Thera Solutions has expanded its collaboration with SteinCares, granting it exclusive rights to market a third biosimilar in Brazil and the LATAM region Bio-Thera will handle development, the US FDA & the EMA submissions to support LATAM regulatory filings & commercial supply of each biosimilar from its Chinese manufacturing facilities SteinCares will utilize its…
December 16, 2024

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Celltrion
NEWS

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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NEWS

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

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Galderma
NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) 

Shots:   The US FDA has approved Nemluvio + TCS ± calcineurin inhibitors (TCI) to treat mod. to sev. atopic dermatitis in patients unresponsive to topical therapies Approval was based on the P-III (ARCADIA) study of the combination vs PBO in patients (n=1,728; ≥12yrs.), showing significant skin clearance in both co-1EPs of IGA score (0/1) &…
December 13, 2024

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Checkpoint Therapeutics
NEWS

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

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MERCK
NEWS

 Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma 

Shots:    The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25 Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…
December 13, 2024

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NEWS

CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE) 

     Shots:    The CHMP has recommended Andembry as a prophylactic treatment of HAE in patients (≥12 yrs.), with the EC’s decision anticipated in Q1’25, based on P-III (VANGUARD) trial & ongoing OLE study The P-III study (full results published in The Lancet) of Andembry vs PBO met its 1EP, showing attack-free status in 62% while…
December 13, 2024

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Geron
NEWS

Geron Receives Positive CHMP Opinion for Rytelo (Imetelstat) to Treat Transfusion-Dependent Anemia due to Lower-Risk MDS 

Shots:   The CHMP has recommended Rytelo to treat TD anemia in adults with very low, low, or intermediate risk non-del(5q) MDS, unresponsive or ineligible for erythropoietin-based therapy, with the EC’s decision expected in the coming months Opinion was based on P-III (IMerge) study of Rytelo vs PBO that showed reduced need for RBC transfusions within…
December 13, 2024

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Galderma
NEWS

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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