Shots:
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…
NEWS
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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,…
Shots:
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…
Shots:
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…
Shots:
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…
Shots:
The US FDA and EMA have accepted the BLA & MAA, respectively, for PB016, a biosimilar version of Entyvio (vedolizumab) lyophilized vial for IV administration
BLA was supported by an extensive development program assessing PB016 vs Entyvio, to evaluate its similarity to the reference product, consistent with regulatory requirements for biosimilar approval
PB016 is…
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The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer
Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…
Shots:
IMPACT Therapeutics has entered into an exclusive licensing agreement with Pharmanovia for the exclusive rights to manufacture, develop, and commercialise senaparib in EMEA, Australia, and New Zealand
As per the deal, Pharmanovia will acquire exclusive rights to manufacture, develop & commercialise senaparib across EMEA, Australia & New Zealand, with IMPACT eligible for upfront, regulatory…
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The EC has approved Datroway (datopotamab deruxtecan) for the 1L treatment of adults with unresectable or metastatic TNBC, who are ineligible for PD-1/PD-L1 inhibitor therapy; regulatory review is ongoing in China & Japan, as well as Australia, Canada, Singapore & Switzerland as part of Project Orbis
Approval was backed by the global P-III (TROPION-Breast02)…

