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Designing Compliant Clinical Trial Protocols for Innovative CGT Products: Key Considerations from a Clinical Design Perspective in the Pre-IND Stage
03/02/2026
Designing Compliant Clinical Trial Protocols for Innovative CGT Products: Key Considerations from a Clinical Design Perspective in the Pre-IND Stage
As Cell and Gene Therapy (CGT) products transition from the laboratory to the clinic, the design of the clinical trial protocol is not only the starting point for scientific exploration but also the c...
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From “Treatment” to“Cure”: The Disruptive Evolution of the CGT Clinical Evaluation System
02/06/2026
From “Treatment” to“Cure”: The Disruptive Evolution of the CGT Clinical Evaluation System
When an innovative therapy aiming for a "one-time cure" is still evaluated by traditional standards that measure "months of survival," its failure may have been predetermined. In 2...
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8 Tech Trends Shaping Healthcare in 2026
01/19/2026
8 Tech Trends Shaping Healthcare in 2026
——From AI-driven drug discovery to quantum computing, technology is redefining every aspect of medicine.Generative AI for Drug DiscoveryGenerative AI acts as a super-powered research assistant, simu...
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FDA Crackdown on Trial Design: What July's CRLs to Replimune and Capricor Mean for Sponsors
08/18/2025
FDA Crackdown on Trial Design: What July's CRLs to Replimune and Capricor Mean for Sponsors
Recent Complete Response Letters (CRL) issued to Replimune and Capricor have made the FDA’s new and intensified scrutiny of clinical trial design clear. As the agency demands greater rigor and ...
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CXO Sector: Valuation Re-rating Under Way
08/18/2025
CXO Sector: Valuation Re-rating Under Way
Source: 21st Century Health (original reporting) The warmth spreading through China’s pharma space is now radiating downstream to the entire outsourcing chain. WuXi AppTec now expects 2025 top-line ...
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CROs on Fire: Davis Double Play Has Arrived
08/18/2025
CROs on Fire: Davis Double Play Has Arrived
After a multi-day winning streak, the CRO concept index hit a fresh high on 25 Jul. Porton (300363.SZ), Pharmaron (3759.HK) and Tigermed (300347.SZ) surged more than 5 %, with dozens of peers ...
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