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NEWS

Astrazeneca
AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)
Shots: The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation Trial showed…
June 6, 2025
Tracer Biotechnologies Collaborates with QIAGEN to Co-Develop and Commercialize Tracer dPCR & Tracer WGS for Solid Tumors
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…
June 6, 2025
HUTCHMED and Innovent Biologics Report NMPA’s NDA Acceptance of Fruquintinib + Sintilimab for Renal Cell Carcinoma
Shots: 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…
June 5, 2025
Cullinan and Genrix Bio
Cullinan Therapeutics Enters a ~$712M Licensing Deal with Genrix Bio for Velinotamig
Shots: 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…
June 5, 2025
Roche
The EC Approves Roche’s Evrysdi Tablet for Spinal Muscular Atrophy
Shots: 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…
June 5, 2025
Eli Lilly and Camurus
Eli Lilly Licenses Camurus’ FluidCrystal Technology to Advance Long-Acting Incretin Products
Shots: 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…
June 5, 2025
TelaBio
TELA Bio Launches OviTex Inguinal for Robotic and Laparoscopic Inguinal Hernia Repair in the EU
Shots: 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…
June 4, 2025
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