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Nurix has enrolled the first patient in the global P-III (DAYBreak CLL-306) study assessing bexobrutideg in pts with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received a covalent BTK inhibitor
The trial, conducted under the collaboration between Nurix and Roche, is expected to enroll ~620 pts, where they will be randomized…
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The EC has approved an extension of the indication of MenQuadfi to incl. infants (≥6wks.) for protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, & Y
Approval was supported by extensive data from the MET58 clinical study, which evaluated the immunogenicity, safety, & tolerability of MenQuadfi in infants from 6wks. of…
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Biocon has reported the commercial launch of Yesafili, a biosimilar version of Eylea 2mg (aflibercept), in the US, which was previously approved & granted interchangeable designation
In the P-III (INSIGHT) study in Diabetic Macular Edema (DME), Yesafili showed no clinically meaningful differences from Eylea in PK, safety, efficacy, or immunogenicity
Yesafili is a VEGF inhibitor…
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Lantheus to merge with a wholly-owned subsidiary of Curium US, combining Curium’s global theranostics platform with Lantheus’ US radiodiagnostics business; closing expected in H1’27
As per the deal, Curium will acquire Lantheus for $102.5/share in cash, with shareholders eligible for ~$12/share in non-transferable CVRs, representing total consideration of up to $114.50/share & a transaction…
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Pathos AI has entered into a licensing agreement with Jiangsu Alphamab Biopharmaceuticals for JSKN016, a TROP2/HER3 bispecific ADC independently developed by Alphamab
As per the deal, Pathos AI will receive exclusive rights to research, develop, manufacture & commercialize JSKN016 outside Greater China, funding all related costs, while Alphamab retains exclusive rights in mainland China,…
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Invenio has completed patient enrollment in the ON-SITE study evaluating NIO Lung Cancer Reveal, an AI-based image analysis module for rapid assessment of bronchoscopic lung biopsy specimens imaged with the NIO Imaging System
The study enrolled 1,006 pts, involving >3,250 fresh biopsy specimens across 7 US medical centers, with specimens collected using transbronchial forceps biopsy,…
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The US FDA has approved Garzulys (SC & IV), a biosimilar to NovoLog (insulin aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus
Garzulys was developed through a collaboration among Tonghua Dongbao, NKF, Xentria, Meitheal, & Emerge. Tonghua Dongbao developed the drug substance, NKF the drug product, Xentria led clinical…
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The NMPA has approved IND application to initiate P-Ib/II trial of opamtistomig (LBL-024) in combination therapy for metastatic colorectal cancer (mCRC)
Trial will evaluate the safety & efficacy of opamtistomig combination regimens in pts with mCRC & explore potential predictive biomarkers. Opamtistomig mechanism was already validated across EP-NEC, NSCLC, SCLC, & biliary tract cancer…
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The US FDA has approved Rituximab, a biosimilar version of Rituxan developed by Dr. Reddy's Laboratories, supported by analytical, non-clinical, and clinical data demonstrating high similarity and no clinically meaningful differences from Rituxan, meeting US biosimilar requirements
Rituximab is a mAb targeting CD20 on B cells, leading to B-cell depletion through immune-mediated mechanisms. It is approved in the US for…
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The US FDA has granted IND clearance for RAG-1C for the prevention & treatment of Proliferative Vitreoretinopathy (PVR)
The P-I trial will assess the safety, tolerability, PK, & preliminary efficacy of RAG-1C in patients undergoing surgery for retinal detachment who are at high risk of developing PVR
RAG-1C is an intravitreal saRNA therapy using Ractigen’s…

