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Zymeworks
Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer
Shots:The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTCApproval…
Reflow Medical
Reflow Medical’s Spur Peripheral Retrievable Stent System Receives the US FDA’s De Novo Clearance for BTK-CLTI Treatment
Shots:FDA has granted De Novo clearance to the Spur Stent System for treating de novo or restenotic lesions post-predilatation in pts with infrapopliteal arterial diseaseIn recently concluded DEEPER REVEAL trial (n=130), the system achieved 99.2% technical success rate & 97% freedom from MALE & POD at 30 days post-predilatation for below-the-knee (BTK) treatment…
Regeneron & Sanofi
Regeneron and Sanofi Report P-III (AERIFY-1 & AERIFY-2) Trials Data of Itepekimab for Chronic Obstructive Pulmonary Disease (COPD)
Shots:P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
Astellas & Evopoint Bio
Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011
Shots:Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & TaiwanAs per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royaltiesXNW27011, an CLDN18.2-specific…
Top 20 Diagnostics Companies of 2025 
Top 20 Diagnostics Companies of 2025 Shots: Driven by continuous innovation and enhanced precision, the diagnostic industry is advancing rapidly, transforming the way healthcare is delivered In 2025, the global diagnostic testing market is valued at approximately $207.96B in 2025 and is projected to grow to around $272.9B by 2034, reflecting a CAGR of 3%.…

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