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武田收到CHMP肯定意见，推荐ALUNBRIG® (brigatinib)用于治疗既往用过克唑替尼的ALK+非小细胞肺癌患者
马萨诸塞州剑桥和日本大阪 (美国商业资讯) — 武田药品工业株式会社(Takeda Pharmaceutical Company Limited, TSE: 4502)今天宣布，欧洲药品管理局(EMA)人用药品委员会(CHMP)已采纳一项肯定意见，推荐全面核准ALUNBRIG®...
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Samsung Bioepis’ Biologics License Application for SB5 Adalimumab Biosimilar...
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k)...
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Inter Partner Assistance Hong Kong Ltd. Forms a Partnership With The...
HONG KONG Inter Partner Assistance Hong Kong Ltd. has partnered with The CareVoice to provide fully digital health journeys and integrated healthcare solutions to the insurance market. This press...
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AVITA Medical Announces Presentation of RECELL® System Effectiveness and...
VALENCIA, Calif. & MELBOURNE, Australia AVITA Medical (ASX: AVH, OTCQX: AVMXY), a global regenerative medicine company, today announced that the results from two U.S. pivotal clinical trials...
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PerkinElmer and DBT- ICT Inaugurate “explorer™ G3 Project”– an Advanced...
MUMBAI, India PerkinElmer, Inc., a global leader committed to innovating for a healthier world, collaborated with Institute of Chemical Technology (ICT) to open “explorerTM G3 Project,” an advanced...
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Takeda Establishes Record Date for the Extraordinary General Meeting of...
OSAKA, Japan Further to the announcement of the recommended acquisition of Shire plc (“Shire”) on May 8, 2018 (“the Acquisition”), Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda” or the...
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Alnylam Announces Submission of New Drug Application in Japan for ONPATTRO™...
CAMBRIDGE, Mass. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that it has submitted a New Drug Application (NDA) to Japan’s Pharmaceuticals...
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F351 Liver Fibrosis Trial Shows Positive Efficacy
TOKYO GNI Group Ltd., (“GNI Group”; TOKYO: 2160) has received a recommendation from the independent data monitoring committee (IDMC) reviewing the F351 drug candidate’s Phase II liver fibrosis trial...
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武田薬品、クリゾチニブによる前治療歴のあるALK陽性非小細胞肺がん患者の治療薬としてALUNBRIG®（ブリガチニブ）を推奨するCHMPの肯定的見解を取得
米マサチューセッツ州ケンブリッジ & 大阪 （ビジネスワイヤ）– 武田薬品工業株式会社（TSE: 4502）は本日、欧州医薬品庁（EMA）の医薬品評価委員会（CHMP）...
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Dr. Reddy’s Laboratories Announces the Launch of Imatinib Mesylate Tablets,...
HYDERABAD, India & PRINCETON, N.J. Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the...
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Seattle Genetics and Takeda Announce Positive Results from Phase 3 ECHELON-2...
BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502) announced today that the phase 3 ECHELON-2 clinical...
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Five Prime Therapeutics and Zai Lab Dosed First Patient in Phase 3, Global...
SOUTH SAN FRANCISCO, Calif. & SHANGHAI Five Prime Therapeutics, Inc. (Nasdaq: FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, and Zai...
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武田薬品、臨時株主総会の基準日を確定
大阪 （ビジネスワイヤ） — 武田薬品工業株式会社（東証：4502）は本日、2018年5月8日付けのシャイアーplc買収提案の発表に関して、買収提案に関連する必要事項について決議する臨時株主総会の基準日を以下のとおり定めたことを発表しました。 臨時株主総会の基準日...
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Acorda to Present Data for INBRIJA™ (levodopa inhalation powder) at...
ARDSLEY, N.Y. Acorda Therapeutics, Inc. (Nasdaq:ACOR) will present a new post-hoc efficacy analysis from SPAN-PD, the pivotal Phase 3 trial of INBRIJA, at the upcoming International Congress of...
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武田薬品、進行性ALK陽性NSCLCに対するファーストライン治療でALUNBRIG®（ブリガチニブ）がクリゾチニブと比較して病状進行ないし死亡のリスクを5...
米マサチューセッツ州ケンブリッジ & 大阪 （ビジネスワイヤ） — 武田薬品工業株式会社（TSE: 4502）は本日、第3相ALTA-1L試験（ALK in Lung Cancer Trial of BrigAtinib in 1st...
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武田呈报的ALTA-1L试验阳性数据显示，ALUNBRIG® (brigatinib)用于晚期ALK+...
马萨诸塞州剑桥和日本大阪 (美国商业资讯) — 武田药品工业株式会社(Takeda Pharmaceutical Company Limited, TSE: 4502)今天宣布，3期ALTA-1L（ALK in Lung Cancer Trial of BrigAtinib in 1st...
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CANbridge Pharmaceutical Submits New Drug Application for NERLYNX®...
BEIJING CANbridge Pharmaceutical Inc., a biopharmaceutical company developing Western drug candidates in China and North Asia, announced that it has filed a New Drug Application (NDA) to China’s...
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ＰＨＣホールディングス株式会社：細胞治療・再生医療分野を中心としたヘルスケアソリューションの開発強化のために、新たな首都圏研究開発拠点を設置
東京 （ビジネスワイヤ） — ＰＨＣホールディングス株式会社（本社：東京都港区）の１００％子会社である、ＰＨＣ株式会社（以下、「ＰＨＣ」）は、このたび、湘南ヘルスイノベーションパーク（*１）（以下、「湘南アイパーク」）における研究開発活動を開始しましたので、お知らせいたします。...
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Notice of Personnel Changes to Corporate Officers at SanBio Co., Ltd. and at...
TOKYO SanBio Co., Ltd. and US subsidiary SanBio, Inc. conducted the following personnel transfers, effective October 1, 2018. 1. Transfer DetailsAkihiro Tsujimura will become a senior corporate...
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CORRECTING and REPLACING CANbridge Pharmaceutical Submits New Drug...
BEIJING Second sentence of first paragraph of release dated October 2, 2018, should read: The NMPA has accepted the NDA application. (instead of The NMPA has accepted the IND application.). The...
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