BioPharma Drug Discovery
Nordic Bioscience Secures FDA Letter of Support for CPa9-HNE Biomarker in Advancing IBD Clinical Trials
Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug ...
November 12, 2024 | News
Australia’s Neurizon Therapeutics Secures Positive EMA Opinion for Orphan Medicinal Product Designation of NUZ-001 in ALS
Notice of positive opinion received from the European Medicines Agency for Orphan Medicinal Product Designation for NUZ-001 in Amyotrophic Lateral S...
November 12, 2024 | News
Harbour BioMed Files IND Application in China for Novel Antibody Therapy HBM9378/SKB378 Targeting COPD
Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel ant...
November 11, 2024 | News
Dizal Submits NDA to U.S. FDA for Sunvozertinib as a New Treatment Option for Advanced NSCLC with EGFR Exon 20 Insertion Mutations
Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announ...
November 11, 2024 | News
BioIVT and KRISHGEN BioSystems Forge Exclusive Agreement to Expand Access to High-Quality Biospecimen Solutions Across South Asia
-BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, announced an exclusive agreement* with KRI...
November 07, 2024 | News
China’s Leads Biolabs Secures FDA Orphan Drug Designation for LBL-034 in Multiple Myeloma Treatment
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs") announced that LBL-034, a humanized bispecific T-cell engaging antibody target...
November 07, 2024 | News
Medidata Introduces Oncology and Vaccine Solutions to Streamline Phase II and III Trials with FDA-Aligned Patient-Centric Design
The new products combine Medidata's diverse technologies and experience from thousands of previous trials to streamline the management of Phase II an...
November 05, 2024 | News
Breast Cancer Drug Shows Promise for Treating Hereditary Hemorrhagic Telangiectasia, a Rare Vascular Disorder
A drug commonly used to treat breast cancer might be able to help people living with hereditary hemorrhagic telangiectasia (HHT) – a rare genetic ble...
November 05, 2024 | News
Senhwa Biosciences Appoints Dr. Yiu-Lian Fong to Board of Directors for Strategic Growth in Oncology and Precision Medicine
Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious disea...
November 04, 2024 | News
Taiwan’s CStone Secures UK Approval for Sugemalimab as First-Line Treatment for Metastatic NSCLC
This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the Eur...
November 01, 2024 | News
Taiwan’s Formosa Pharmaceuticals Partners with Portugal’s DÁVI Farmacêutica to Introduce APP13007 for Post-Surgical Ocular Pain Relief in Europe
Taiwan-based Formosa Pharmaceuticals ("Formosa", 6838.TW) announced that the company has entered into an exclusive licensing agreement with DÁVI Far...
November 01, 2024 | News
Thermo Fisher’s $22M OSD Investment: Shervin Hebbi on Accelerating Drug Development with Cutting-Edge Technology
In an exclusive Q&A with BioPharma APAC, Shervin Hebbi, Vice President of Oral Solid Dose (OSD) – North America at Thermo Fisher ...
November 01, 2024 | Interview
Hong Kong’s Akeso Biopharma Enrolls First Patient in Pioneering Phase III Trial for Advanced Head and Neck Cancer Therapy
Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (A...
October 31, 2024 | News
GC Biopharma and Novelty Nobility Join Forces to Develop New Antibody Therapy for Geographic Atrophy in Age-Related Macular Degeneration
GC Biopharma announced that it has signed an agreement with Novelty Nobility, a biotech company specializing in the development of antibody-based therapeut...
October 29, 2024 | News
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