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NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…
September 18, 2025

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Astrazeneca
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AstraZeneca Reports Interim P-III (TULIP-SC) Trial Data of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: AstraZeneca has reported interim P-III (TULIP-SC) trial data assessing Saphnelo (anifrolumab; 120mg, SC, QW, accessorisedPFS) vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC Interim analysis conducted after the first 220 pts reached Wk. 52, showed Saphnelo reduced disease activity (1EP), measured by BICLA at Wk. 52; data to be…
September 18, 2025

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Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the EC’s Approval for Retinal Diseases

Shots: The EC has approved 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 Approval was based on P-III trials conducted across the EU, South Korea, & Japan,…
September 17, 2025

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Areteia Therapeutics Reports P-III (EXHALE-4) Trial Data of Dexpramipexole to Treat Eosinophilic Asthma

Shots: Areteia Therapeutics has reported P-III (EXHALE-4) trial data assessing dexpramipexole (75 or 150mg, PO, BID) vs PBO as an add-on therapy to treat pts (n=600; ≥12yrs.) with inadequately controlled moderate-to-severe asthma & blood AEC ≥300 cells/μL Trial showed that 150mg improved lung function over Wks. 20 & 24 (1EP), as measured by pre-BD FEV1…
September 17, 2025

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Biocartis Reports the US FDA’s Approval of Idylla CDx MSI Test to Identify MSI-H Colorectal Cancer Patients

Shots: The US FDA has approved the PMA application for Idylla CDx MSI Test, a cartridge-based, fully automated “sample-to-result” companion diagnostic, with US launch anticipated soon & availability in other non-US markets to follow The Idylla CDx MSI Test helps identify MSI-H colorectal cancer pts eligible for Opdivo (nivolumab) alone or with Yervoy (ipilimumab), as…
September 17, 2025

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Novo-Nordisk
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Novo Nordisk Reveals P-III (REDEFINE 1) Trial Data of Cagrilintide for Weight Loss in Obese/Overweight 

Shots: Novo Nordisk has reported a sub-analysis of P-III (REDEFINE 1) trial assessing cagrilintide monotx. (2.4mg) with lifestyle intervention vs PBO in 3,417 obese/overweight pts with ≥1 obesity-related comorbidities, & without type 2 diabetes Trial showed 11.8% superior weight loss vs 2.3% after 68wks., while 31.6% lost ≥15% of body weight vs 4.7%. However, weight…
September 16, 2025

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Merck and Daiichi Sankyo’s Raludotatug deruxtecan Receives FDA’s Breakthrough Therapy Designation for Ovarian, Primary Peritoneal, or Fallopian Tube Cancers 

Shots: The US FDA has granted BTD to Raludotatug deruxtecan (R-DXd) for the treatment of adults with Pt-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with Avastin Designation was based on P-I trial (n=179) & the ongoing P-II/III (REJOICE-Ovarian01) trial (n=~710), with subgroup analysis of P-I presented at…
September 16, 2025

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VarmX Inks a ~$2.2B Strategic Collaboration and Option Agreement with CSL for VMX-C001 to Advance Coagulation Treatment

Shots: VarmX has collaborated with CSL to advance its lead asset, VMX-C001 (commercial launch expected in 2029), & granted CSL an exclusive option agreement with its shareholders to acquire all issued & outstanding shares of the company As per the collaboration, CSL will fully fund the global P-III (EquilibriX-S) trial of VMX-C001 in FXa DOAC…
September 16, 2025

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