News
Astellas Submits New Drug Application for Zolbetuximab in Japan
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a New Drug Application (NDA) on June 9, 2023 to Japan's Ministry of Health, Labour and Welfare (MHLW) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.
Gilteritinib as Maintenance Therapy Demonstrated Benefit in Subgroups of FLT3-ITD Acute Myeloid Leukemia Patients
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today presented data from the Phase 3 MORPHO clinical trial which demonstrated favorable results in subgroups of FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML) patients, including a subgroup of patients with detectable measurable residual disease (MRD).
Samsung Biologics and Pfizer announce strategic collaboration for long-term manufacturing of biosimilars portfolio
Samsung Biologics (KRX:207940.KS) and Pfizer (NYSE: PFE) today announced a strategic partnership for the long-term commercial manufacturing of Pfizer’s multi-product portfolio.
Gencurix Announces Clinical Research Results At ASCO 2023 Demonstrating Outstanding Performance of GenesWell BCT, the Company’s Breast Cancer Prognostic Test, Compared to Global Best-Selling Test, OncotypeDX
Gencurix (KOSDAQ #229000), a leading provider of cancer molecular diagnostics, announced the release of clinical research results directly comparing the accuracy of its breast cancer prognostic test, GenesWell BCT, with Oncotype DX, the globally top-selling test, confirming its outstanding performance.
Lunit and Capio S:t Göran Hospital Collaborate to Address Radiologist Shortage with AI-Powered Mammography Analysis
Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer diagnostic solutions, today announced the signing of a supply and license agreement with Capio S:t Göran Hospital, Stockholm, Sweden.
IMBdx Expands Targeted Therapies Agreement Following Successful Evaluation of Blood-Based Genomic Profiling Assay in Prostate Cancer
IMBdx Inc., a premier precision cancer diagnostic company accredited by CAP, announced today its plans to broaden its collaboration with AstraZeneca, a leading global biopharmaceutical company.
Samsung Biologics accelerates timeline of new fifth plant to be operational by April 2025
While attending the 2023 BIO International Convention, Samsung Biologics (KRX:207940.KS), a leading contract development and manufacturing organization (CDMO), revealed details of the company's future expansion plan to have its new fifth plant operational by April 2025.
Late-breaking SCG101 Data Show 100% HBsAg+ Hepatocyte Eradication and 74.5% HCC Tumour Reduction With Single Dose HBsAg-specific TCR-T Cell Therapy
SCG Cell Therapy Pte Ltd (SCG), a clinical-stage biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, presented late-breaking data from its first-in-class autologous HBsAg-specific T-Cell receptor-engineered T Cell (TCR-T) Therapy – SCG101 – at the International Society for Cell & Gene Therapy (ISCT) conference in Paris, France.
Dr. Reddy’s Successfully Completes Phase I Study (IV Route) of DRL_TC, a Proposed Biosimilar of Tocilizumab
HYDERABAD, India–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced ... Read more
Shineco Subsidiary Registered as a Member of Pharmaceutical Chamber of Commerce
Shineco Life Science Research Co., Ltd., was registered as a member of the All-China Federation of Industry and Commerce Medical & Pharmaceutical Chamber of Commerce (the “Pharmaceutical Chamber of Commerce”), and Ms. Jennifer Zhan, CEO of Shineco, became a member of the Pharmaceutical Chamber of Commerce.
