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Curium and Lantheus to Merge in an ~$8B Deal
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…
Pathos AI Inks ~2.2B Licensing Deal with Alphamab Oncology for JSKN016
Shots: 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,…
Invenio Imaging Completes Enrollment in Pivotal ON-SITE Study for NIO Lung Cancer Reveal
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,…
Meitheal Pharmaceuticals
Meitheal Secures FDA Approval for Garzulys (Biosimilar, NovoLog)
Shots: 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…
Leads Biolabs Reports NMPA IND Clearnce to Initiate P-Ib/II Trial for Opamtistomig Combination Therapy in mCRC
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…
Novartis Reports the US FDA Approval of Pluvicto for mHSPC
Shots: 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…
IMPACT Therapeutics Inks Exclusive Licensing Agreement with Pharmanovia for Senaparib in EMEA, Australia and New Zealand
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…
Astrazeneca & Daiichi Sankyo
Daiichi Sankyo and AstraZeneca Report the EC Approval for Datroway to Treat Metastatic Triple Negative Breast Cancer
Shots: 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)…