Valby, Denmark and Tokyo, Japan, 30 November 2018 – H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today the achievement of positive clinical results (in intention-to-treat population) as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score change from baseline compared to placebo, when brexpiprazole and …
Tag Archives: Otsuka
November, 2018
October, 2018
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26 October
FDA Grants Priority Review to Taiho Oncology’s sNDA for Lonsurf for Treatment of GEJ Adenocarcinoma
PRINCETON, N.J., October 25, 2018 – Taiho Oncology, Inc. today announced that the United States Food and Drug Administration (FDA) has accepted and granted priority review for the supplemental New Drug Application (sNDA) for LONSURF® (trifluridine/tipiracil, TAS-102) as a treatment for patients with previously treated, advanced or metastatic gastric adenocarcinoma, including …
August, 2018
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2 August
Astex and Otsuka Announce that Guadecitabine Fails to Meet Endpoints in Late-Stage AML Study
otsuk PLEASANTON, Calif. & TOKYO–(BUSINESS WIRE)–Astex Pharmaceuticals, a member of the Otsuka group of companies, and Otsuka Pharmaceutical Co. Ltd., announce top-line results from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine (SGI-110) in adults with previously untreated AML who are not eligible for intensive induction chemotherapy. The …
July, 2018
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11 July
Otsuka to Expand its Pipeline of Antibody-Based Therapies through its $430 Million Acquisition of Visterra
TOKYO & WALTHAM, Mass.–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Visterra, Inc. (Visterra) announce that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Visterra for approximately USD 430 million in an all-cash transaction. The Otsuka and Visterra boards of directors have approved the transaction. …
April, 2018
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25 April
FDA Approves Otsuka’s Jynarque as the First Treatment to Slow Kidney Function Decline in Patients at Risk of Rapidly Progressing ADPKD
TOKYO–(BUSINESS WIRE)–Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that the U.S. Food and Drug Administration (FDA) has approved JYNARQUE™ (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). ADPKD is a genetic disease with consequences that can lead …
December, 2017
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15 December
GW Pharma Reacquires Full Rights to Develop and Commercialize Sativex in the US
London, UK, 13 Dec 2017: GW Pharmaceuticals plc (Nasdaq: GWPH, “GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announces the termination of its previous license agreement with Otsuka Pharmaceutical Co., Ltd. in relation to Sativex®(nabiximols) in the U.S. …
October, 2015
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27 October
GW and Otsuka Announce Phase 3 Results from its Sativex Trials
LONDON and PRINCETON, N.J., Oct. 27, 2015 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (“GW”) and Otsuka Pharmaceutical Development & Commercialization, Inc. (“Otsuka”), today reported top-line results from the remaining two Phase 3 trials for the investigational product Sativex® in the treatment of pain in patients with advanced cancer …