Current Headlines

  1. Luye Pharma Announces Innovative Drug - Risperidone Extended Release Microspheres For Injection Has Reached Final Stage Of NDA Process

    Luye Pharma Group, an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that it has entered the final stage of New Drug Application (NDA) submissions for the innovative drug, Risperidone Extended Release Microspheres for Injection ('LY03004), after previous positive pre-NDA meeting with the U.S. Food and Drug Administration (FDA) and subsequent related procedures

  2. Xynomic Pharma Will Present At ASCO-GU Cancers Symposium, Files 3 INDs For Potentially Pivotal Cancer Trials In China, And Expands R&D Operations

    Xynomic Pharma, a clinical stage US-China oncology drug development company, today announced that its Trials-in-Progress poster discussing the ongoing, potentially pivotal, phase 3 trial of abexinostat plus pazopanib as first- or second-line therapy in patients with locally advanced or metastatic renal cell carcinoma (RCC) will be presented by Dr. Rahul Aggarwal of University of California San Francisco, a lead investigator, at the ASCO-Genitourinary Cancers Symposium on February 16, 2019 in San Francisco, California, USA

  3. China's NMPA Approves Innovent's Anti-PD-1 Antibody Tyvyt® (Sintilimab Injection) For Hodgkin's Lymphoma

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL)

  4. Hebrew University To Collaborate With KYORIN

    Yissum, the Technology Transfer Company of The Hebrew University of Jerusalem and KYORIN Pharmaceutical Co., Ltd. (Tokyo, Japan), a subsidiary of KYORIN Holdings, Inc., which is engaged in the development and commercialization of prescription drugs, announced today a strategic collaboration in the discovery of respiratory drug therapies

  5. TRACON Pharmaceuticals Announces Submission Of IND Application For TJ4309 (CD73 Antibody TJD5) For Treatment Of Advanced Solid Tumors

    TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer, today announced that TRACON has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of TJ4309 in patients with advanced solid tumors

  6. Lupin And AbbVie Announce Partnership To Develop And Commercialize Novel Oncology Drug To Treat Hematological Cancers

    Pharma major Lupin Limited (Lupin) and global biopharmaceutical company AbbVie Inc., recently announced that AbbVie has licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program

  7. I-Mab Receives U.S. FDA IND Approval For Proprietary Anti-GM-CSF Monoclonal Antibody TJM2

    I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, today announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF), with the best-in-class potential to treat autoimmune and inflammatory diseases

  8. CytRx Corporation Announces Conclusion Of Pre-Clinical Phase For Its Albumin Binding Ultra High Potency LADR™ Drug Candidates And Accompanying Companion Diagnostic

    CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that its private, wholly-owned subsidiary Centurion BioPharma Corporation (the Company) has concluded the pre-clinical phase of its development for its albumin binding ultra high potency LADR™ (Linker Activated Drug Release) drug candidates, LADR-7, LADR-8, LADR-9 and LADR-10, and for its unique albumin companion diagnostic (ACDx). As a result of completing this work, operations taking place at the pre-clinical laboratory located in Freiburg, Germany will no longer be needed

  9. Ayala Pharmaceuticals Signs Deal To Develop And Commercialize AL102 In Combination With BCMA Targeting Agents In Multiple Myeloma

    Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically identified, announced recently that it entered into an option to license agreement with Novartis for its investigational agent AL102 in multiple myeloma

  10. Spirita Oncology Initiated Global Clinical Development Of E6201 In Collaboration With JS InnoPharm (Shanghai) Under Strategic Partnership Alliance And Sub-License Agreement

    Spirita Oncology, LLC, announced that it has entered into a sublicense agreement with JS Innopharm (Shanghai) Ltd. to initiate global clinical development of E6201, a potent MEK1 inhibitor with excellent brain penetration. In August 2018, Strategia Holdings, LLC, a parent company of Spirita Oncology, LLC, and JS Innopharm initiated a Strategic Partnership Alliance to facilitate global drug development