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CStone Partners with Arrotex to Commercialize Sugemalimab in Australia and New Zealand

Arrotex, the pharmaceutical commercialization platform of DBG, Australia's leading diversified healthcare group, will be responsible for the registration...

June 29, 2026 | News

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

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

Avance Clinical Expands APAC And China Operations To Accelerate Global Biotech Trials

Avance Clinical, the Australian-headquartered global Contract Research Organization (CRO) for biotechs, announced a significant expansion of its Asia Pacif...

June 22, 2026 | News

HaemaLogiX Secures Ethics Approval For Phase 2b KappaMab Clinical Trial In Relapsed Multiple Myeloma

Ethics approval received from the Alfred Hospital Human Research Ethics Committee (Bayside Health) for Phase 2b KappaMab™ clinical trial “HLX...

June 22, 2026 | News

Dimerix Signs Up to AU$481 Million Licensing Deal with Everest Medicines to Advance Phase 3 Kidney Disease Therapy Across Asia

Dimerix Limited (ASX: DXB), a biopharmaceutical company developing innovative therapies for rare inflammatory diseases, has entered into an exclusive licen...

June 17, 2026 | News

CGBIO Expands Global NOVOSIS Partnership With DePuy Synthes Into North America And Australia

DePuy Synthes secures exclusive commercialization rights in North America and Australia; the two companies to jointly advance global clinical development...

May 28, 2026 | News

Caliway Advances Global Phase 3 Programme For CBL 514 Following U.S. FDA IND Clearance

Asia-Pacific Phase 2 Study CBL-0206 Also Approved by Australia HREC and Taiwan TFDA, Accelerating Global Dual-Track Strategy ...

May 26, 2026 | News

Registrar Corp And U.S. Commercial Service Strengthen Support For Australian Exporters Entering U.S. Market

Registrar Corp, the global leader in U.S. Food and Drug Administration (FDA) regulatory compliance services, partnered with the U.S. Commercial Servic...

May 26, 2026 | Regulatory

Scribe Therapeutics Gains Australian Clearance To Begin First Human Trial Of STX 1150 For Hypercholesterolemia

Scribe Therapeutics, Inc. (Scribe), a clinical-stage biotechnology company engineering purpose-built in vivo CRISPR technologies designed to exte...

May 26, 2026 | News

HaemaLogiX Opens Phase 1 KOALA Trial Of KMCAR T Cell Therapy For Relapsed Multiple Myeloma

Phase 1 KOALA clinical trial evaluating KMCAR™ T-cell therapy in relapsed/refractory kappa-restricted multiple myeloma now open for patient enrolme...

May 21, 2026 | News

Racura Oncology Receives Positive Safety Review Committee Recommendation To Advance CPACS Trial In Advanced Solid Tumours

Safety Review Committee (SRC) gives Racura Oncology a recommendation to continue the Cardioprotection and Anticancer Synergy (CPACS) study in advanced soli...

May 18, 2026 | News

Australia’s NinaMED Launches With $13.75 Million Financing To Advance Global Commercialisation Of Non Invasive OAB Therapy

US$13.75M financing completed to accelerate clinical pathway and global commercialisation Establishment of NinaMED Pty Ltd, a new Australian medtech com...

May 15, 2026 | News

Australia Registers PEDMARQSI As First Approved Therapy To Prevent Cisplatin Related Hearing Loss In Children

PEDMARQSI® is now TGA registered in Australia for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 ...

May 07, 2026 | News

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