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BI has entered into a strategic research collaboration with Combotope to leverage its SMART-Phage platform to produce highly tumor-selective antibodies for next-generation cancer therapies
Combotope will discover tumor-selective, high-affinity antibodies against multiple BI oncology targets, while BI will hold global development & commercialization rights, and lead further R&D, manufacturing, & commercialization activities
As per…
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Spotlight Medical has received CE marking under the EU IVDR for myStage Dx, an AI-enabled prognostic test designed to support risk stratification in patients with ER+/HER2- early breast cancer
Test analyzes digitized H&E-stained FFPE pathology slides alongside routine clinicopathological variables to generate a binary prognostic classification of Low Risk or Not Low Risk
In…
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The EC has approved Trodelvy monotx. as a 1L therapy for the treatment of adults with unresectable or metastatic TNBC who are ineligible for PD-1/PD-L1 inhibitor therapy across all 30 EEA states
Approval was backed by the P-III (ASCENT-03) trial showing a 38% reduced risk of disease progression or death in patients who are…
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Abbisko Therapeutics has entered into a strategic research collaboration & license agreement with Eli Lilly to discover & develop novel therapeutics across multiple targets
Abbisko will leverage its early-stage drug discovery platform, R&D ecosystem, & development expertise to conduct discovery & early-stage development of novel therapeutics against disease targets selected by Lilly
As per…
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Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products
Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty
Denosumab is a mAb that works…
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The EC has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with Familial Chylomicronemia Syndrome (FCS), backed by the P-III (PALISADE) trial assessing it (25 & 50mg, SC, Q3M) vs PBO in 75 FCS adults
Trial met its 1 & all multiplicity-controlled key 2EPs. 25mg showed an 80% vs…
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The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs.
Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed…
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Nuvectis has licensed exclusive ex-China rights to NXP100 (HSK39297; QD, PO), a Complement Factor B inhibitor, & NXP200 (HSK42360), a brain-penetrant paradox-breaker BRAF inhibitor from Haisco, transforming the company into a late-stage development player
As per the deal, Haisco will receive ~$40M in upfront & near-term payments, plus up to $1.421B in development,…
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Antengene has licensed ATG-106, a preclinical CDH6×CD3 bispecific T-cell engager for solid tumors, to K2 Therapeutics & granted an option for exclusive rights to a second undisclosed bispecific TCE candidate, covering all global markets excl. Greater China
As per the licensing deal, Antengene will receive $20M in upfront & near-term consideration, incl. cash &…
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TrueLab has granted Bionyra exclusive worldwide rights, excl. Greater China, to research, develop, manufacture, & commercialize TL-001, an anti-TL1A monoclonal antibody, & TL-003, a TL1A × IL-23p19 bispecific antibody
As per the deal, TrueLab will receive ~$985M in total consideration, incl. an upfront payment as well as development, regulatory, & commercial milestone payments, with tiered…

