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Fresenius Kabi
NEWS

Fresenius kabi Secures the CHMP’s Positive Opinion for Bomyntra & Conexxence (Biosimilar, Prolia and Xgeva)

Shots:  The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25  The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD,…
May 27, 2025

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Autolus
NEWS

Autolus Therapeutics’ Obecabtagene Autoleucel Receives the CHMP’s Positive Opinion for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The CHMP has recommended Obecabtagene Autoleucel (obe-cel; autologous CD19 CAR T cell therapy) for treating pts (≥26yrs.) with r/r B-ALL; EC’s decision on conditional MAA is expected within 2mos. Opinion was based on the P-Ib/II (FELIX) study assessing obe-cel in over 100 adults with r/r B-cell precursor ALL across 30 sites in the US, UK &…
May 27, 2025

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SpringWorks Therapeutics
NEWS

The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

Shots: The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25 The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…
May 26, 2025

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GSK New
NEWS

GSK Receives the CHMP’s Positive Opinion for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

S Shots: CHMP recommended Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; EC decision expected in Q3’25. Review ongoing in the US (PDUFA: Jul 23, 2025), Canada, China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Opinion was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494…
May 26, 2025

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Vertex Pharmaceuticals
NEWS

Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis

S R Shots:    The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New Zealand Vanzacaftor &…
May 1, 2025

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NEWS

The CHMP Adopts Positive Opinion on Alnylam Pharmaceuticals’ Vutrisiran to Treat ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Shots: The CHMP has recommended vutrisiran to treat ATTR-CM adults based on global P-III (HELIOS-B) study assessing it vs PBO in ATTR-CM pts; EC's decision expected in Jun 2025. MAA under PMDA review, with global applications planned in 2025 & beyond Study met all ten 1 & 2EPs across both overall & monotx. arms, showing improved…
April 29, 2025

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Prilenia & Ferrer
NEWS

Prilenia Therapeutics Collaborates with Ferrer to Co-Develop and Commercialize Pridopidine for Indications Beyond Huntington’s Disease (HD)

Shots: Prilenia & Ferrer have entered into a collaboration & license agreement to co-develop & commercialize pridopidine for indications beyond HD in Europe & select markets, with Prilenia retaining rights in major markets incl. North America, Japan, & APAC As per the deal, Prilenia will receive ~$90.8M upfront, ~$51.1M in near-term development, regulatory, & commercial…
April 28, 2025

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Italfarmaco
NEWS

Italfarmaco Obtains the CHMP’s Positive Opinion for Conditional Marketing of Duvyzat to Treat Duchenne Muscular Dystrophy (DMD)

Shots: Opinion for Duvyzat to treat ambulant DMD pts (≥6yrs.) with corticosteroids is based on P-III (EPIDYS) study assessing Duvyzat (BID) vs PBO in ambulant boys (n=179); EC’s decision expected in Jul 2025 Trial met its 1EP by improving four-stair climb completion time, with benefits seen in 2EPs  (NSAA & MRI fat infiltration) & a…
April 28, 2025

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