Shots:
Tracer has entered into a strategic collaboration with QIAGEN to co-develop & commercialize Tracer dPCR & Tracer WGS MRD assays for solid tumors on QIAGEN’s QIAcuity digital PCR platform
Collaboration aims to provide highly sensitive, cost-effective, & decentralized MRD testing using QIAcuity’s PCR platform, allowing oncologists to monitor cancer recurrence & guide personalized treatment…
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Avicenna.AI has received the European CE Mark approval for its AI-powered tools, CINA-VCF Quantix & CINA-CSpine to detect & assess unsuspected vertebral compression fractures (VCFs) & cervical spine fractures, respectively in pts undergoing CT scans
CINA-VCF Quantix analyzes chest &/or abdomen CTs in pts (≥50yrs.), where it automatically labels vertebrae as well as calculates…
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China’s NMPA has accepted NDA of fruquintinib + sintilimab for the treatment of pts with locally advanced or metastatic renal cell carcinoma who have progressed on one tyrosine kinase inhibitor therapy
NDA is backed by the P-II/III (FRUSICA-2) trial assessing fruquintinib + sintilimab vs axitinib/everolimus monotx. for 2L treatment of renal cell carcinoma pts…
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The NMPA has approved cadonilimab + Pt-based CT ± Avastin as a 1L treatment of persistent, recurrent, or metastatic cervical cancer
Approval was based on the P-III (COMPASSION-16) trial assessing cadonilimab vs SoCs, which met its PFS & OS endpoints, showing efficacy in PD-L1-negative tumors (CPS <1; 27.9% vs 24.2%) with subgroup analyses demonstrating benefit…
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Alvotech has entered into a collaboration & license agreement with Dr. Reddy’s to co-develop, manufacture & commercialize a biosimilar version of Merck's Keytruda (pembrolizumab) globally
As per the deal, Alvotech & Dr. Reddy’s will jointly develop & manufacture the biosimilar candidate, sharing costs & responsibilities, with each retaining the right to commercialize it globally,…
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Genrix Bio has granted Cullinan exclusive global license to velinotamig, excl. Greater China for all indications, with Cullinan planning to develop it in autoimmune diseases
As per the deal, Genrix will receive $20M upfront, ~$292M in development & regulatory milestones & ~$400M in sales-based milestones, with net sales-based tiered royalties from mid-single digits up to…
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The EC has approved label extension of Evrysdi (5mg oral tablet) for pts with spinal muscular atrophy (SMA)
Approval was based on P-I study assessing Evrysdi 5mg tablet vs oral solution, showing bioequivalence with comparable efficacy & safety; data was presented at SMA Europe 2024
Evrysdi, an SMN2 splicing modifier, treats SMA caused by…
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Camurus has granted Eli Lilly exclusive global rights to research, develop, manufacture, & commercialize long-acting incretin drugs using Camurus’ FluidCrystal tech for cardiometabolic diseases
As per the deal, Camurus will receive ~$290M in upfront, development & regulatory milestones as well as $580M in sales-based milestones & global net sales-based tiered royalties in mid-single digits…
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TELA Bio has launched OviTex Inguinal in the EU for laparoscopic & robotic-assisted inguinal hernia repair; OviTex Inguinal to be showcased at EHS 2025
OviTex Inguinal is available in 2 trocar-compatible configurations, consisting of 3 or 4 layer anatomically shaped devices that provide surgeons with flexible options designed to meet pts, technique, or procedure-specific needs…
Shots:
Zoetis has launched AI Masses for its Vetscan Imagyst analyzer to detect neoplastic cells in animals; AI Masses is available in North America starting Jun 2, 2025
AI Masses uses advanced deep learning algorithms to identify & classify common skin/subcutaneous masses & lymph node lesions in real time, improving point-of-care access & client satisfaction,…

