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NEWS

Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases

Shots: The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial…
July 30, 2025

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NEWS

Viridian Therapeutics Enters a ~$385M Deal with Kissei Pharmaceutical to Develop and Commercialize Veligrotug and VRDN-003 in Japan

Shots: Viridian & Kissei have entered into an exclusive collaboration & license agreement to develop & commercialize veligrotug & VRDN-003 in Japan As per the deal, Kissei will secure an exclusive license to develop & commercialize veligrotug & VRDN-003 in Japan, with the responsibility of all development, regulatory, & commercialization activities, & related costs in…
July 30, 2025

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Eli lilly
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Eli Lilly Reports Topline P-III (BRUIN CLL-314) Trial Results of Jaypirca (Pirtobrutinib) to Treat CLL/SLL

Shots: The P-III (BRUIN CLL-314) trial assessed Jaypirca vs Imbruvica in 650 pts with treatment-naïve or experienced (but BTK-naïve) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) Trial met its 1EP of ORR non-inferiority in both pre-treated & ITT pts, with ORR favoring Jaypirca; PFS was immature but showed favorable trend, especially in treatment-naïve pts…
July 30, 2025

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NEWS

IntraBio’s Aqneursa Receives the CHMP’s Positive Opinion for Treating Niemann-Pick Disease Type C (NPC)

Shots: The CHMP has recommended Aqneursa (levacetylleucine) for treating adults & pediatric pts with NPC; additional global submissions are planned for 2025 & beyond Approval was backed by P-III (IB1001-301) study assessing Aqneursa vs PBO in pts (≥4yrs.; n=60) with NPC, which showed improved neurological symptoms & function across all 1 & 2EPs within 12wks.,…
July 30, 2025

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Apellis
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Apellis Pharmaceuticals Reports the US FDA’s Approval of Empaveli for C3 Glomerulopathy and Primary IC-MPGN

Shots: The US FDA has approved Empaveli (pegcetacoplan) for C3 glomerulopathy (C3G) & primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) pts (≥12yrs.) Approval was based on P-III (VALIANT) trial assessing Empaveli (Q2W) vs PBO in C3G & primary IC-MPGN pts (≥12yrs., n=124) for 26wks. followed by 26wk. open-label period, where all pts received Empaveli Trial met…
July 30, 2025

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NEWS

Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3'25 Opinion was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without…
July 29, 2025

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Ionis
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Ionis Reports the CHMP’s Positive Opinion on Tryngolza for Familial Chylomicronemia Syndrome

Shots: The CHMP has recommended Tryngolza (olezarsen) as an adjunct to diet in adult patients for the treatment of genetically confirmed familial chylomicronemia syndrome; EC’s decision is expected in Q4’25 Opinion was based on P-III (Balance) trial assessing (Q4W) vs PBO, which showed reduced triglyceride levels at 6mos., sustained through 12mos., with decrease in acute…
July 29, 2025

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NEWS

Sobi Reports the US FDA’s Approval of Doptelet (Avatrombopag) to Treat Pediatric Immune Thrombocytopenia

Shots: The US FDA has approved Doptelet to treat thrombocytopenia in pts (≥1yrs.) with persistent or chronic ITP who have not responded to prior treatments. Approval also incl. a new formulation, Doptelet Sprinkle (avatrombopag) oral granules, for children (1-6yrs.) Approval was based on P-III (AVA-PED-301) study assessing Doptelet in pediatric ITP pts, which showed that…
July 28, 2025

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NEWS

Memo Therapeutics Reports P-II (SAFE KIDNEY II) Trial Data on Potravitug to Treat BKPyV Infection in Kidney Transplant Recipients

Shots: Memo Therapeutics has reported P-II (SAFE KIDNEY II) trial data assessing potravitug vs PBO for the treatment of BK polyomavirus (BKPyV) infection in kidney transplant recipients (n=95) Trial didn’t meet its 1EP of undetectable BKPyV DNAemia but showed superior viral response (≥1-log₁₀ reduction) & resolution of biopsy-proven BKPyVAN by Wk. 20, with histological improvement from…
July 28, 2025

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