Japan
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD).
Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan
Guardant Health, Inc. (Nasdaq: GH) announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare for its Guardant360® CDx liquid biopsy test for comprehensive genomic profiling for patients with advanced or metastatic solid tumor cancers.
Shionogi Further Extends Infectious Disease Innovation Platform with Planned Acquisition of Qpex Biopharma, Inc.
Shionogi Inc. will acquire Qpex Biopharma, Inc.
Astellas Establishes Open Innovation Hub for Tumor Microenvironment Research with Cutting-Edge Spatial Biology, in Mitsui Fudosan’s “MITSUI LINK-Lab KASHIWA-NO-HA 1”
Astellas Pharma Inc. (TSE: 4503) and Mitsui Fudosan Co., Ltd. (TSE: 8801) announced today that Astellas will establish a "TME imaging and interactive research for innovation (TME iLab)" open innovation hub in October, 2023 in "MITSUI LINK-Lab KASHIWA-NO-HA 1" (Kashiwa City, Chiba Prefecture, "the Lab") operated by Mitsui Fudosan.
Sosei Heptares Provides Update on Lotiglipron Development
osei Group Corporation (“the Company”; TSE: 4565) notes the decision by its partner Pfizer to prioritize the development of clinical-stage GLP-1 receptor agonist candidate danuglipron for the treatment of diabetes and obesity and as a result has discontinued the development of lotiglipron.
Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced positive topline results from the Phase 3b DAYLIGHT clinical trial for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
ASLAN Pharmaceuticals Enters Into a Strategic Licensing Deal With Zenyaku Kogyo for the Development and Commercialization of Eblasakima in Japan
ASLAN Pharmaceuticals Enters Into a Strategic Licensing Deal With Zenyaku Kogyo for the Development and Commercialization of Eblasakimab in Japan
Takeda Presents Full Data Set from Phase 3 ADVANCE-CIDP 1 Clinical Trial Investigating HYQVIA® as a Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting
OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda(TSE:4502/NYSE:TAK) today announced full results from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial investigating HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Jadeite Medicines Receives Orphan Drug Designation for Odevixibat in Progressive Familial Intrahepatic Cholestasis (PFIC) from the Ministry of Health, Labour and Welfare of Japan and will also initiate Phase 3 Trial of Odevixibat in PFIC in Japan
TOKYO, June 20, 2023 /PRNewswire/ -- Jadeite Medicines Inc., (Jadeite Medicines) a clinical stage biopharmaceutical company headquartered in Tokyo, Japan (President & CEO, Eiichi Takahashi) has received Orphan Drug Designation for odevixibat for the expected indication of PFIC from the Ministry of Health, Labour and Welfare (MHLW) of Japan.
Metagen Therapeutics Completes Series A Financing Raising a Total of $12.1 Million
TSURUOKA, Japan, June 15, 2023 /PRNewswire/ -- Metagen Therapeutics (President & CEO: Taku Nakahara), a company focusing on drug discovery and development based on intestinal microbiome-based therapeutics for various diseases, has completed its Series A funding in 2 rounds, raising a total of 1.7 billion yen.
