All News
Amarin and Lotus Pharmaceuticals Announce Exclusive Partnership Agreement to Commercialize Vazkepa® (Icosapent Ethyl) in Southeast Asia and South Korea
Amarin Corporation plc (NASDAQ:AMRN) and Lotus Pharmaceuticals (1795:TT; “Lotus”) today announced that the two companies have entered into a long-term exclusive partnership to distribute and commercialize VAZKEPA® (icosapent ethyl) across 10 countries, including nine in Southeast Asia (the Association of Southeast Asian Nations - ASEAN) and South Korea.
China’s National Medical Products Administration Accepts Astellas’ Biologics License Application for Zolbetuximab
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for zolbetuximab.
HUTCHMED Reports 2023 Interim Results and Provides Business Updates
HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:HCM; HKEX:13), the innovative, commercial-stage biopharmaceutical company, today reports its unaudited financial results for the six months ended June 30, 2023 and provides updates on key clinical and commercial developments.
NMPA and FDA Approved the First-in-Human Clinical Trial Applications to Evaluate LBL-034, An Anti-GPRC5D/CD3 Bispecific Antibody Developed by Leads Biolabs, in Relapsed/Refractory Multiple Myeloma
Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma. Currently, no GPRC5D-targeting antibody has been approved for marketing.
Akeso Inc. Published 2023 Interim Results Positive Profit Alert
Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, today announced that it is expected that the Company will record a profit of not less than RMB2.3 billion for the six months ended June 30, 2023.
Skincare Tech Brand AMIRO Receives QTL Certification from SGS to Strengthen R&D Efforts
AMIRO ("the Company"), a leading beauty and skincare technology brand, is thrilled to announce that its research facility, AMIRO LAB, has successfully obtained the Qualified Testing Location (QTL) certification after a comprehensive audit conducted by SGS.
U.S. FDA Accepts Biologics License Application for GC Biopharma’s GC5107B (Immune Globulin Intravenous (Human), 10% Liquid)
GC Biopharma (006280.KS), a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's resubmission of the Biologics License Application (BLA) for its GC5107B (Immune Globulin Intravenous (Human) for patients with primary humoral immunodeficiency (PI).
Seegene unveils solutions to popularize molecular diagnostics at 2023 AACC
Seegene Inc. (KQ096530), a leading South Korean company providing a total solution for PCR molecular diagnostics, took part in the 2023 American Association of Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo in California between July 25-27.
Biosion Announces Phase II Study Start for Anti-TSLP mAb BSI-045B in Atopic Dermatitis (ADAMANT)
Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, today announced the phase 2 study initiation for the evaluation of BSI-045B, an anti-TLSP mAb, in the treatment of atopic dermatitis (AD) .
GLOBAL SARCOMA THERAPY NOW LISTED ON PHARMACEUTICAL BENEFITS SCHEME
AUSTRALIAN cancer patients who have been diagnosed with rare soft tissue sarcomas will now have affordable access to a global therapy shown to improve survival, following its listing on the Pharmaceutical Benefits Scheme (PBS).
