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Saluda Medical has reported the European CE Mark approval of its EVA Sensing Technology to manage pain with spinal cord stimulation, with recognition of this approval in Australia
The company is planning a limited commercial launch in EU & Australia for Q1’26, followed by a full commercial rollout in both regions later in the…
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MediLink has entered into an additional collaboration & exclusive licensing agreement with Roche for the development & commercialization of YL201 (B7H3 ADC) across numerous solid tumor types
Under the deal, Roche will obtain an exclusive license to develop, manufacture, & commercialize YL201 worldwide, excl. Mainland China, Hong Kong SAR, & Macau SAR
In return,…
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The Chinese NMPA has approved Redemplo to reduce triglycerides (TGs) in adults with FCS; regulatory review is ongoing in other regions
Redemplo will be commercialized by Sanofi in Greater China under an agreement with Arrowhead, with NMPA approval triggering a $10M milestone payment from Sanofi to Arrowhead’s subsidiary Visirna Therapeutics
Redemplo is an siRNA…
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Foresee has entered into an exclusive global licensing agreement with Primevera for its MMP-12 inhibitor programs, which incl. FP-025, FP-020 & third-generation MMP-12 inhibitors in discovery stage
As per the deal, Foresee USA will receive a $10M upfront, ~$574.5M in milestones, & tiered single-digit royalties, or alternatively a tiered share of sublicense proceeds in lieu…
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GSK has reported P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in over 1,800 pts from 29 countries for the treatment of chronic hepatitis B (CHB)
Both trials met the 1EP, with bepirovirsen delivering a statistically significant, clinically meaningful functional cure & showing superior cure rates vs SoC; Results were…
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Merck has initiated P-III (KANDLELIT-007) trial of calderasib (MK-1084) + Keytruda Qlex for the 1L treatment of pts with KRAS G12C-mutant, advanced or metastatic nonsquamous NSCLC
Trial will assess calderasib (PO, QD) + Keytruda Qlex (SC; Q6W) vs Keytruda Qlex + pemetrexed (IV) + CT in ~ 675 newly diagnosed pts with KRAS G12C-mutant nonsq. NSCLC, evaluating PFS as 1EP…
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InduPro has entered into a global strategic collaboration & licensing agreement with Eli Lilly to discover novel oncology treatments using InduPro’s proximity-guided platform
Lilly will gain access to InduPro’s AI/ML-enabled MInt platform, with InduPro leading early discovery to identify co-target pairs & advance bispecific & multispecific antibody programs from the collaboration
As per the…
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Eli Lilly has entered into a definitive agreement to acquire Ventyx, strengthening Lilly’s capabilities in inflammatory-mediated diseases
As per the deal, Eli Lilly will acquire Ventyx for $14/share in an all-cash transaction, representing an aggregate equity value of ~$1.2B; closing is expected in H1’26
Ventyx is advancing a pipeline of oral small-molecule therapies, incl.…
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The P-III (HERIZON-GEA-01) trial assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as the 1L treatment in 914 adults with HER2+ locally advanced or metastatic GEA
Ziihera + CT & Ziihera + Tevimbra + CT showed prolonged PFS with 35% risk reduction delivering mPFS of 12.4mos., with mOS of 24.4 & 26.4mos., respectively,…
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Fresenius Kabi has launched Otulfi, an interchangeable biosimilar version of Stelara (ustekinumab), in a 45 mg/0.5 mL single-dose vial presentation for SC injection
FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev.…

