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NEWS

Sandoz
Sandoz Launches Pyzchiva Autoinjector (Biosimilar, Stelara) in the EU for Chronic Inflammatory Diseases
Shots: Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to…
May 23, 2025
Vigil Neuro
Sanofi to Acquire Vigil Neuroscience for ~$470M
Shots: Sanofi has entered into an agreement to acquire Vigil Neuroscience incl. its asset VG-3927 (TREM2 agonist), strengthening its neurology pipeline; Vigil’s VGL101 program is not a part of the acquisition As per the deal, Sanofi will acquire Vigil for ~$470M, with shareholders receiving $8/share in cash & a non-transferable CVR of $2/share payable upon the…
May 22, 2025
Astrazeneca
AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC
Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…
May 22, 2025
Genentech & Orionis
Genentech Collaborates with Orionis to Identify and Develop Molecular Glue Therapies for Cancer Targets
Shots: Genentech has entered into a multi-year collaboration with Orionis to discover small-molecule monovalent glue drugs for novel & difficult oncology targets using Orionis’ Allo-Glue platform As per the deal, Orionis will receive $105M upfront & ~$2B in research, development, commercial, & sales milestones, with tiered royalties; Orionis will lead discovery & optimization, while Genentech…
May 22, 2025
Celltrion
Celltrion’s Yuflyma (Biosimilar, Humira) Receives the US FDA’s Interchangeability Designation for All Presentations
Shots: FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes Designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev.…
May 22, 2025
Ramsoft & Therapixel
RamSoft and Therapixel Form a Commercial Partnership For an Integrated AI Breast Imaging Solution
Shots: RamSoft Inc. and Therapixel have entered into a commercial partnership to integrate Therapixel’s MammoScreen AI-powered breast imaging software into RamSoft’s PowerServer and OmegaAI platforms This collaboration integrates Therapixel's MammoScreen, breast imaging AI, directly into RamSoft's platforms Recent studies showed that MammoScreen improves radiologist performance with 8% higher sensitivity, 2% higher specificity, and 24% faster…
May 21, 2025
Innocare Pharma
China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL
Shots: InnoCare Pharma has approved Minjuvi (tafasitamab) + Lenalidomide, followed by Minjuvi monotx., for treating adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT) Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, combined with lenalidomide, is already approved for treating eligible DLBCL pts. in Hong Kong, Macau,…
May 21, 2025
Kalivir Immunotherapeutics
KaliVir Immunotherapeutics Reports Completion of First Cohort of P-I/Ib (STEALTH-001) Study in Advanced Solid Tumors
Shots: KaliVir Immunotherapeuticsreported completion of the first cohort in P-I/Ib (STEALTH-001) study evaluating VET3-TGI as a monotx. and in combination with a checkpoint inhibitor in advanced, unresectable, or metastatic solid tumor pts.  The Data Safety Committee reviewed initial safety data and approved the progression of VET3-TGI to the next IT and IV dosing cohorts VET3-TGI is an…
May 21, 2025
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