Industry Insight | French Biotech Allogenica Secures €2.5M Grant to Advance Universal CAR-T Therapy Industrialization
Allogenica, a biotechnology company based in Lyon, has secured €2.5 million in funding from the French government’s France 2030 strategic investment program. The grant will accelerate the industrial...
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Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Evaluation of Immune-related Adverse Events in Antitumor Therapy” (No. 25, 2022)
Tumor immunotherapy is a hot topic in the current research and development of new anti-tumor drugs. How to improve the scientificity and robustness of the identification and judgment of immune-related...
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Industry Insight | AstraZeneca and Algen Biotechnologies Forge $555 Million Gene Therapy Collaboration
October 6, 2025 — San Francisco, USA – AstraZeneca announced a strategic collaboration and licensing agreement with Algen Biotechnologies, a U.S.-based biotech company specializing in AI-driven gene...
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Hillgene Winning the Bid on the First Contract Manufacturing Order for Commercial CAR-T Cell Therapy in China
It is reported that Shanghai Xianbo Biotechnology Co., Ltd. and Jiangsu Puxin Biopharmaceutical Co., Ltd. have reached a strategic cooperation agreement, entrusting Puxin Bio to carry out the second p...
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Hillgene Takes Note of FDA New Guidelines: Interpreting the Latest Developments and Industry Opportunities in Cross-Border Genetic Data Research
The U.S. Food and Drug Administration (FDA) recently issued an important announcement stating it will pause new clinical trial applications led by U.S. institutions that involve sending cells from U.S...
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[GMP revised] Appendix for “Investigational Drugs (Interim)” issued and taking effect as of July 1!
In accordance with Article 310 of the Good Manufacturing Practice for Pharmaceuticals (Revised in 2010), the Appendix to the Drugs for Clinical Trial Use (Trial) is hereby issued as a supporting docum...
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Industry Insight | EU Issues First-Ever GMP Annex on Artificial Intelligence: 10 Key Compliance Requirements for Pharmaceutical AI
Brussels, July 7, 2025 — The European Commission and PIC/S (Pharmaceutical Inspection Co-operation Scheme) have jointly released the draft “GMP Annex 22: Artificial Intelligence (AI)”, launching a ...
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Center for Drug Evaluation (CDE) Issued the Notification of “Technical Guideline for the Pharmaceutical Study and Evaluation of Ex-vivo Genetic Modification System (Interim)” (No. 29, 2022)
In order to standardize and guide the pharmaceutical research of in vitro gene modification systems, under the deployment of the National Drug Administration, the Drug Evaluation Center organized the ...
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