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Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar...
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference...
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TÜV Rheinland: Notified Body for the New Medical Device Regulation
COLOGNE, Germany TÜV Rheinland LGA Products GmbH is now a notified body for the EU Medical Device Regulation (MDR) 2017/745. The European Medical Device Regulation 2017/745 (MDR) came into effect on...
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Incyte Announces Positive Updated Results from Phase 2 Trial of Pemigatinib...
WILMINGTON, Del. Incyte (Nasdaq:INCY) announces updated results, including the final result for the primary endpoint, from its Phase 2 FIGHT-202 trial evaluating pemigatinib, a selective fibroblast...
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CORRECTING and REPLACING Incyte Announces Positive Updated Results from Phase...
WILMINGTON, Del. Sixth paragraph, fourth sentence of release should read: Serous retinal detachment was observed in 4 percent of patients (Grade ≥3, 1 percent) with none of the cases resulting in...
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世界睡眠大会上呈报的新数据展示了选择性食欲肽2型受体(OX2R)激动剂TAK-925治疗1型发作性睡病患者有效性的早期征象
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,...
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インサイト、白斑患者でルキソリチニブ・クリームを評価する第3相臨床試験プログラムで最初の患者が治療を受けたと発表
米デラウェア州ウィルミントン （ビジネスワイヤ） — インサイト（Nasdaq:INCY）は本日、第3相TRuE-V臨床試験プログラムで最初の患者が治療を受けたと発表しました。本プログラムは、白斑の青年・成人患者（年齢12歳以上）に対する単剤療法としてのルキソリチニブ・クリームの安全性と有効性を評価するものです。...
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Seattle Genetics and Astellas Announce Results from Phase 1 Trial of...
TOKYO & BOTHELL, Wash. Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced initial results from the...
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CAP Laboratory Accreditation Program Expands Inspector Training Footprint in...
TOKYO The College of American Pathologists (CAP) and CGIkk hosted laboratory accreditation inspector training for 20 pathologists from leading institutions across Japan. The September 28 training...
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三叶草生物制药在研1类新药SCB-313中国恶性腹水I期临床完成首例患者给药
成都 (美国商业资讯)–三叶草生物制药，一家致力于创新及变革性生物药物研发的生物制药公司，今天宣布在中国进行的另一项SCB-313 I期临床试验完成首例患者给药。SCB-313是一种创新重组人肿瘤坏死因子相关凋亡诱导配体（TRAIL）-...
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Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in...
CHENGDU, China Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced that the first patient was dosed in another Phase...
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CAP検査室認定プログラムが日本で審査員研修の参加機関を拡大
東京 （ビジネスワイヤ） — 米国病理医協会（CAP）とCGIkkは、日本の有力機関に所属する病理医20人を対象とする検査室認定審査員研修を開催しました。9月28日の研修は、CAPに代わって検査室を認定する審査員を地域でさらに増やし、検査室の質と正確性を確保して患者ケアを改善する上で、最初の取り組みとなります。...
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アビオメッド、低侵襲の順行性心臓ポンプSmartAssist搭載Impella 5.5に対するFDA PMAを取得
米マサチューセッツ州ダンバース （ビジネスワイヤ） — アビオメッド（NASDAQ: ABMD）最新の心臓ポンプであるSmartAssist搭載Impella 5.5は、心原性ショックの最大14日までの治療の安全性と有効性が認められ、米国食品医薬品局（FDA）より市販前承認（PMA)を取得しました。...
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Ocugen and CanSinoBIO Enter Strategic Partnership for Gene Therapy...
MALVERN, Pa, & TIANJIN, China Ocugen, Inc., (NASDAQ: OCGN), a clinical stage biopharmaceutical company focused on innovative therapies that address rare and underserved eye diseases, has entered...
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Celltrion to Launch TemixysTM Double Combination Once-Daily Tablet for HIV...
INCHEON, South Korea Celltrion (KRX:068270) announced that it is launching TemixysTM in the U.S. which were approved in November by U.S. Food and Drug Administration (FDA). Celltrion anticipates...
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AVITA Medical Announces Listing on Nasdaq
VALENCIA, Calif. & MELBOURNE, Australia AVITA Medical (ASX: AVH, NASDAQ: RCEL), a regenerative medicine company with a technology platform positioned to address unmet medical needs in...
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ナルコレプシー1型患者でオレキシン2受容体（OX2R）選択的作動薬TAK-925の有効性を初期段階で示す新データを世界睡眠学会で発表
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） —...
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Elanco Advances Margin Expansion Journey with Business Restructuring
GREENFIELD, Ind. Since its September 2018 initial public offering (IPO), Elanco Animal Health Inc. (NYSE: ELAN) has continued to evaluate its capabilities, structure and staffing to meet its goal of...
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Cognitive Improvement Demonstrated With Xanamem™: Actinogen Medical
SYDNEY Actinogen Medical ASX: ACW (‘ACW’ or ‘the Company’) is delighted to announce results from the XanaHES (Xanamem in Healthy Elderly Subjects) trial. The results demonstrate a significant...
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SIRION Biotech to Participate in Major International Industry Conferences
MARTINSRIED, Germany SIRION Biotech GmbH (“SIRION”) today announced its participation in major international conferences this October. SIRION, offering the most comprehensive portfolio of custom...
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Nuwiq®の製品概要更新版には個別化予防療法における週2回投与の効果的出血予防に関するデータを掲載
スイス・ラッヘン （ビジネスワイヤ） — オクタファルマは本日、欧州医薬品庁が血友病A患者の個別化予防療法に関する情報を含むNuwiq®の製品概要（SmPC）更新版を承認したと発表しました。更新版SmPCはhttps://www.ema.europa.eu/en/medicines/human/EPAR/nuwiqでご確認できます。...
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