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Celltrion
NEWS

Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the CHMP Positive Opinion for Multiple Immune-Mediated Diseases

Shots: The CHMP has recommended Celltrion's Steqeyma autoinjector (45mg/0.5mL & 90mg/1mL), a biosimilar version of Stelara (ustekinumab), for the treatment of pts with plaque psoriasis, psoriatic arthritis (PsA) & Crohn’s disease (CD) SteQeyma (CT-P43) is a human anti-IL-12 & IL-23 monoclonal antibody that is also available in SC formulation (45mg/0.5 mL or 90mg/1 mL in…
December 18, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in November 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks  In…
December 16, 2025

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NEWS

Sobi Reports the CHMP Positive Opinion of Aspaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The CHMP has recommended Sobi's Aspaveli (pegcetacoplan) for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.), with EC decision expected in Q1’26 Opinion was based on P-III (VALIANT) trial assessing Aspaveli(Q2W) vs PBO in C3G or primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all…
December 15, 2025

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NEWS

Cytokinetics Reports the CHMP Positive Opinion on Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26 Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups &…
December 15, 2025

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NEWS

GSK Reports the CHMP Positive Opinion of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots: CHMP recommended GSK's depemokimab as add-on maintenance therapy for asthma pts (≥12yrs.) with type 2 inflammation (eosinophilic) & as add-on therapy for inadequately controlled CRSwNP, based on P-III (SWIFT & ANCHOR) trials, respectively; EC’s decision expected in Q1’26 SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma exacerbations by 54% over 52wks. (1EP)…
December 15, 2025

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Ionis and Otsuka
NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…
November 17, 2025

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NEWS

BioNet’s VacPertagen Receives the CHMP’s Positive Opinion for Pertussis Disease 

Shots:  The CHMP has recommended VacPertagen as a booster aganist Pertussis for pts (age≥12) and for passive infant protection via maternal immunization during pregnancy   VacPertagen is an acellular pertussis vaccine with two components, including recombinant Pertussis Toxin (PTgen) and filamentous haemagglutinin (FHA), providing targeted protection without unnecessary antigens   VacPertagen’s benefits have been demonstrated in three clinical studies involving adults, adolescents, and pregnant women  Ref: BioNet| Image: BioNet| Press Release…
November 13, 2025

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