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エマウスライフサイエンス社、ニューイングランド・ジャーナル・オブ・メディシン誌が鎌状赤血球症の治療でEndari™（L-グルタミン経口粉末薬）を検討した第...
米カリフォルニア州トーランス市 （ビジネスワイヤ） — VIEW E-MEDIA KIT –...
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22nd Century宣布可立即执行FDA的尼古丁削减规划
纽约州威廉姆斯维尔 (美国商业资讯) — 22nd Century Group, Inc. (NYSE American:XXII) 是一家植物生物技术公司，也是烟草减害和极低尼古丁烟草领域的领先者，公司昨天回应了美国食品药品管理局(FDA)的提议规定预先通知...
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Gynesonics Names George Quinoy Vice President, Global Sales
REDWOOD CITY, Calif. Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for uterine fibroids, today announced that veteran medical device sales...
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AVITA Medical Announces Expansion of Management Team to Support Planned U.S....
VALENCIA, Calif. & MELBOURNE, Australia AVITA Medical (ASX: AVH) (OTCQX: AVMXY) today announced that it expanded its management team in the commercial, legal and medical affairs functions to...
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Dr. Reddy’s Announces the Launch of Esomeprazole Magnesium Delayed-Release...
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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Alpine Immune Sciences Completes Sale of S-Nitrosoglutathione Reductase...
SEATTLE & HANGZHOU, China Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a company focused on discovering and developing innovative, protein-based immunotherapies to treat cancer,...
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Emmaus Life Sciences宣布《新英格兰医学杂志》发表 Endari™（左旋谷氨酰胺口服粉剂）治疗镰状细胞病3期试验结果
加州托伦斯 (美国商业资讯) — 参阅电子媒体包 – Emmaus Life Sciences, Inc. (Emmaus)今天宣布，《新英格兰医学杂志》(NEJM)已发表该公司Endari™（左旋谷氨酰胺口服粉剂）48周3期临床试验的结果，2017年7月，FDA依据该试验核准Endari™用于减少成人和5岁及以上儿童镰状细胞病患者的急性并发症。...
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22ndセンチュリーはFDAのニコチン低減計画が直ちに実行可能であると発表
米ニューヨーク州ウィリアムズビル （ビジネスワイヤ） — タバコの有害性低減と超低ニコチンタバコでリードする植物バイオテクノロジー企業の22ndセンチュリー・グループ（NYSE...
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SanBio: Joint Research Agreement for SB623 Targeting Dementia
TOKYO SanBio Company Limited, a scientific leader in regenerative medicine for neurological disorders, today announced it has concluded an agreement with Keio University School of Medicine on joint...
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FDA核准首款用于脊柱椎体间融合的纳米技术Peek器械
新罕布什尔州纳舒厄 (美国商业资讯) — 医疗器械公司Vallum Corporation今天宣布，美国食品药品管理局(FDA)已核准一款聚醚醚酮(PEEK)脊柱椎体间融合器械，该器械采用Vallum专有和受专利保护的加速中性原子束(ANAB)技术绘制的PEEKplus®纳米纹理1表面。 PEEKplus®是首款也是唯一获得FDA核准的PEEK椎体间器械纳米纹理表面。...
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Takeda Announces Phase 3 Trial of ALUNBRIG® (brigatinib) Met Primary Endpoint...
CAMBRIDGE, Mass. & OSAKA, Japan Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the global, randomized, Phase 3 ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line)...
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NeuroVia Initiates Phase 1/2 Trial of NV1205 for Treating Childhood Cerebral...
SAN FRANCISCO NeuroVia, Inc., a biopharmaceutical company focused on developing innovative therapies for rare, genetic neurological diseases, today announced the initiation of a Phase 1/2 clinical...
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Dr. Reddy’s Laboratories Announces the Launch of Hervycta® (trastuzumab...
HYDERABAD, India Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY) announced today that it has launched Hervycta® (trastuzumab), a biosimilar of Roche’s Herceptin®, in India, indicated for...
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Banyan Biomarkers宣布在《柳叶刀杂志神经科分册》上发表ALERT-TBI临床研究结果
圣迭戈 (美国商业资讯) — 创伤性脑损伤(TBI)生物标记物开发领域的先驱Banyan Biomarkers, Inc.今天宣布发表ALERT-TBI研究结果，这是一项采用Banyan脑损伤指数® (Banyan BTI™)的国际多中心临床试验。Banyan...
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バニヤン・バイオマーカーズ、ALERT-TBI臨床試験の結果がランセット・ニューロロジーに掲載されたと発表
サンディエゴ （ビジネスワイヤ） — 外傷性脳損傷（TBI）用のバイオマーカー開発で草分けとなっているバニヤン・バイオマーカーズは本日、ALERT-TBI試験の結果の論文掲載を発表しました。本試験はBanyan Brain Trauma Indicator®（Banyan BTI™、脳損傷指標)を活用する国際多施設臨床試験です。Banyan...
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武田薬品、ALUNBRIG®（ブリガチニブ）の第3相試験が主要評価項目を達成し、ALK阻害剤未治療の進行性ALK陽性NSCLC患者でクリゾチニブと比較して...
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、グローバルランダム化第3相ALTA-1L試験（ALK in Lung Cancer Trial of AP26113 in 1st...
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武田宣布3期ALUNBRIG®...
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(TSE: 4502)今天宣布，全球随机3期ALTA-1L（ALK in Lung Cancer Trial of AP26113 in 1st...
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Astex Pharmaceuticals and Otsuka Announce Results of the Phase 3 ASTRAL-1...
PLEASANTON, Calif. & TOKYO 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...
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MerLion Regains North American Rights to XTOROTM FDA-Approved Antibiotic for...
SINGAPORE MerLion Pharmaceuticals (MerLion), a pharmaceutical company focused on the advanced clinical development of its antibacterial drug finafloxacin, today announced that Novartis has made a...
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Infraredx Announces Launch of Makoto™ Intravascular Imaging System and...
BURLINGTON, Mass. Infraredx, Inc., a pioneer in intravascular imaging for mapping coronary artery disease, today announced the Makoto™ Intravascular Imaging System, and accompanying Dualpro™...
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