Clinical Trials
Beyond the Trial: Can Real-World Evidence Earn Regulatory Trust in APAC?
A new medicine arrives at a regulator's desk with two kinds of proof attached. The first is the familiar kind: a randomised controlled trial, blinded, cont...
June 30, 2026 | Analysis
NS Pharma Parent Nippon Shinyaku Secures Global Option Rights to Develop Elixirgen's DMD Therapy EXG-7001
NS Pharma, Inc. (NS Pharma; Headquarters, Paramus, NJ; President, Yukiteru Sugiyama) announced that its parent company, Nippon Shinyaku Co., Ltd. (Nippon S...
June 30, 2026 | News
AbbVie Secures U.S. FDA Approval for SKYRIZI in Children with Plaque Psoriasis and Psoriatic Arthritis
SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or activ...
June 30, 2026 | News
Beyond the Obvious Giant: Where APAC's Clinical Trials Go Next
For most of the last decade, the strategic case for running Asia-Pacific clinical trials could be summarised in a single word: China. A vast, treatment-n...
June 29, 2026 | Analysis
Racura Oncology Doses First Patient in Phase 1 HARNESS-1 Trial of RC220 for EGFR-Mutant Lung Cancer
Racura Oncology has dosed the first patient in the HARNESS-1 Phase 1a/b trial of RC220 in combination with osimertinib for EGFR-mutant non-small cell lung ...
June 29, 2026 | News
Everest Medicines' LEROCHOL® BLA Accepted in China for Third-Generation PCSK9 Inhibitor
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...
June 29, 2026 | News
The Frontier That Won’t Quite Arrive
Ask the region’s clinical-operations leaders whether decentralised and hybrid trials are the future, and the answer is almost unanimous. Surveys keep...
June 26, 2026 | Analysis
C-Ray Therapeutics Secures Radiopharmaceutical Production Licence, Strengthening CRDMO Capabilities in China
C-Ray Therapeutics (Chengdu) Co., Ltd. ("C-Ray Therapeutics") completed on-site inspections conducted by a panel of experts from the Sichuan Provincial Cen...
June 25, 2026 | News
Mabwell Secures China Clinical Trial Approval for First-in-Class LILRB4/CD3 Bispecific T-Cell Engager in Blood Cancers
Mabwell (688062.SH, 02493.HK), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that the National Medical P...
June 25, 2026 | News
UniXell Secures US FDA Clearance for Off-the-Shelf Parkinson’s Cell Therapy, Advancing Dual-China-US Clinical Development
UniXell Biotechnology Co., Ltd. ("UniXell") has secured Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for UX-DA...
June 25, 2026 | News
AnHorn Medicines Secures FDA IND Clearance for First-in-Class CIPN Prevention Candidate
AnHorn Medicines announced that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuro...
June 24, 2026 | News
China Approves World's First CAR-T Therapy for Solid Tumours
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announced that as informed by...
June 24, 2026 | News
Europe Greenlights BRAFTOVI, Cetuximab and FOLFOX Regimen for Previously Untreated BRAF-Mutant mCRC
uropean approval is based on results from the Phase 3 BREAKWATER trial, which demonstrated that encorafenib in combination with cetuximab and mFOLFOX6 de...
June 24, 2026 | News
DoH Abu Dhabi and Sanofi Deepen Partnership to Build Next-Generation Vaccine Innovation Hub
The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in Abu Dhabi, and Sanofi, a worldwide biopharma and vaccines...
June 24, 2026 | News
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- Beyond the Trial: Can Real-World Evidence Earn Regulatory Trust in APAC?
- Beyond the Obvious Giant: Where APAC's Clinical Trials Go Next
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