KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Shots: The CHMP has recommended sebetralstat to treat acute attacks of hereditary angioedema (HAE) pts (≥12yrs.); EC’s decision expected by early Oct 2025. Application is under review in Japan & other regions Approval was based on P-III (KONFIDENT) study assessing sebetralstat (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries KONFIDENT data…

ByRidhi RastogiJuly 28, 2025

NEWS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

ByDipanshu DixitJuly 24, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours PharmaShots has compiled a list of 8 drugs that have been…

ByDipanshu DixitJuly 22, 2025

NEWS

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)

Shots: CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025 The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across…

ByDipanshu DixitJuly 4, 2025

NEWS

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

S Shots: Omeros submitted an MAA to the EMA for narsoplimab to treat TA-TMA, with data demonstrating a 61% response rate and a 3x improvement in OS vs matched external controls; over 130 pts treated under expanded access data were also included EMA granted Narsoplimab ODD status, and CHMP review will start mid-July under centralized…

ByPrince GiriJune 30, 2025

NEWS

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Shots: Following the US FDA approval, EMA's CHMP issued a positive opinion of Brukinsa (zanubrutinib) film‑coated tablets for all approved indications. EC will now review the opinion for MAA in the EU, Norway, and Iceland BRUKINSA tablets (160mg) are bioequivalent to the capsule form, supported by a P-I study. With a recommended daily dose of 320mg,…

ByDipanshu DixitJune 27, 2025

NEWS

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Shots: The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…

ByDipanshu DixitJune 24, 2025

NEWS

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Shots: The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25 Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO,…

ByDipanshu DixitJune 23, 2025

NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots: The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…

ByRidhi RastogiJune 23, 2025

NEWS

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Shots: The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. to advanced liver fibrosis; the EC’s decision is expected by Aug 2025 Opinion was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which met its 1EPs of fibrosis improvement…

ByRidhi RastogiJune 23, 2025

KalVista Reports the CHMP’s Positive Opinion on Sebetralstat for Treating Hereditary Angioedema

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

EMA Marketing Authorization of New Drugs in June 2025

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)

Omeros Submits MAA to the EMA for Narsoplimab (OMS721) to Treat TA-TMA

BeOne Receives CHMP Positive Opinion for New Brukinsa Tablet Formulation Across All Approved Indications

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

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