Shots:
Teva has entered into a funding agreement with Royalty Pharma to accelerate the clinical development of Teva’s TEV-’408 for the treatment of vitiligo
As per the deal, Teva will receive ~$500M to support TEV-‘408 development costs, incl. $75M in R&D co-funding for a P-IIb study planned for 2026. Royalty will have an option to…
Shots:
Pfizer has reported data from Cohort 3 of P-III (BREAKWATER) trial, assessing Braftovi (300mg, PO, QD) + cetuximab & FOLFIRI (n=73) vs FOLFIRI ± Avastin (n=74) in pts with previously untreated BRAF V600E-mutated mCRC
In Cohort 3, the combination improved ORR (64.4% vs 39.2%), with 57.4% vs 34.5% achieving ≥6mos. responses; mDoR was not…
RefleXion Medical Reports the US FDA Clearance of RefleXion X2 Platform for Improved Tumor Detection
Shots:
The US FDA has cleared RefleXion X2 with SCINTIX therapy for the treatment of primary & metastatic lung & bone tumors
X2 platform provides a 20-fold increase in PET sensitivity, increasing detectable biological signal levels for tumor imaging & potentially broadening the population eligible for SCINTIX therapy based on imaging criteria
Its wide field-of-view PET detector…
Shots:
The EMA has received MAA of tanruprubart for the treatment of Guillain-Barré syndrome (GBS)
The MAA dossier demonstrated rapid neuroinflammation control & improved recovery, supported by a PoC study & a P-III trial against PBO, favorable risk/benefit, robust US & Southeast Asian biomarker data, PK (US/EU/SE Asia), & RWE matching P-III outcomes to IVIg…
Shots:
Eli Lilly has reported P-IIIb (TOGETHER-PsA) trial assessing concomitant Taltz (ixekizumab) & Zepbound (tirzepatide) vs Taltz alone in 271 adults with active PsA & obesity or overweight with ≥1 weight-related condition
Trial met its 1EP, with 31.7% of pts achieving ACR50 & ≥10% weight loss at Wk. 36 vs 0.8%, & met a key…
Shots:
Pierre Fabre Laboratories has entered into an integrated drug discovery collaboration with Iktos to identify & develop novel small-molecule drug candidates in oncology
As per the deal, Iktos will apply its AI-driven generative design platform to rapidly identify optimized small-molecule candidates for an undisclosed oncology target, while Pierre Fabre will contribute oncology & preclinical expertise…
Shots:
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…
Shots:
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,…
Shots:
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…
Shots:
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…

