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Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a...
OSAKA, Japan & LEUVEN, Belgium Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for...
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BioVectra与Keryx Biopharmaceuticals签署枸橼酸铁扩产协议
爱德华王子岛夏洛特镇 — (美国商业资讯) — 全球性创新合同开发制造组织(CDMO) BioVectra Inc.今天宣布与Keryx Biopharmaceuticals, Inc.签署长期供货协议，以制造Auryxia®片剂的活性药物成分(API)枸橼酸铁，该片剂获准用于治疗慢性肾病的两种常见并发症。 BioVectra...
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武田薬品とシアトル・ジェネティクスが進行期ホジキンリンパ腫のフロントライン治療でアドセトリス（ブレンツキシマブ・ベドチン）を評価する第3相ECHELON-...
米マサチューセッツ州ケンブリッジ & 大阪 & ワシントン州ボセル （ビジネスワイヤ）– 武田薬品工業株式会社（TSE:4502）とシアトル・ジェネティクス（NASDAQ:...
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Dr. Reddy’s announces it has reached a settlement with the US Government...
HYDERABAD, India & PRINCETON, N.J. (BSE: 500124, NSE: DRREDDY, NYSE: RDY)—The US subsidiary of Dr. Reddy’s Laboratories Ltd. announced today that it has reached a settlement with the US...
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ABEC Expands Vessel Supply and Service Capability for Global...
BETHLEHEM, Pa. ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing, today announced its manufacturing facility in Kells, Co. Meath, Ireland has...
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Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate Accepted for Review by...
INCHEON, Korea Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k)...
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ABEC扩张容器供应和服务能力，以服务全球生物医药制造商
宾夕法尼亚州伯利恒 (美国商业资讯)–为生物制药制造提供一体化解决方案和服务的全球领先提供商ABEC今日宣布，公司设在爱尔兰米斯郡Kells的生产工厂已获得了ASME压力容器制造和服务授权认证。ABEC Kells是爱尔兰首个荣获ASME授权认证的设备制造商。 ASME颁发的授权认证彰显了ABEC对ASME...
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JSR Announces Acquisition of Crown Biosciences International
TOKYO JSR Life Sciences (JLS) announced today that JSR Corporation has agreed to purchase Crown Bioscience International (TPEx: ticker 6554) at 12 Billion New Taiwan Dollar, a global drug discovery...
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Certara: A Proud Member of Medicines Development for Global Health’s (MDGH)...
PRINCETON, N.J. Certara®, the global leader in model-informed drug development and regulatory science, today congratulated Medicines Development for Global Health (MDGH), a not-for-profit global...
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LMD欢迎“智能手机即医疗器械”的趋势，强调临床级精度的必要性
瑞士洛桑 (美国商业资讯) — Leman Micro Devices (LMD)是一家受监管消费者医疗保健产品的开发商，受到移动设备行业主要厂商的支持，该公司对其他公司进军该市场表示欢迎，同时对医疗级精度和校准必要性提出警示。 LMD创始人兼首席执行官Mark-Eric...
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Gynesonics Announces Submission of FDA 510k for Incision-Free Treatment of...
REDWOOD CITY, Calif. Gynesonics, a women’s healthcare company focused on the development of minimally invasive solutions for uterine fibroids, today announced its submission to the FDA of its 510(k)...
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エマウスライフサイエンス社の鎌状赤血球治療法の小児臨床治験計画について欧州医薬品庁が肯定的な回答
カリフォルニア州トーランス市 （ビジネスワイヤ） — エマウスライフサイエンス社は、欧州医薬品庁（EMA）の小児委員会（PDCO）が鎌状赤血球症の治療のために同社の小児臨床治験計画（PIP）を受理した、と本日発表しました。この決定により、エマウス社は販売承認申請（MAA）の提出手続きを許可されました。...
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Denis DELVAL被任命为LFB SA首席执行官
法国于利斯 (美国商业资讯) — 12月20日，《Le Journal Officiel》*公布了法国总统的一项行政命令，任命Denis DELVAL为LFB S.A.的首席执行官。该命令是在2017年12月4日LFB SA召开全体大会和董事会会议之后颁布。 本新闻稿包含多媒体。此处查看新闻稿全文：...
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ドニ・デルバールをLFBの最高経営責任者に任命
仏レジュリス （ビジネスワイヤ） — 12月20日、ドニ・デルバールをLFBの最高経営責任者（CEO）に任命するフランス大統領令がLe Journal Officiel*に掲載されました。この命令は、2017年12月4日に開催されたLFB株主総会およびLFB取締役会を受けて公布されました。 本プレスリリースではマルチメディアを使用しています。リリースの全文はこちらをご覧ください。：...
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Walgreens Boots Alliance to Reduce Stake in Guangzhou Pharmaceuticals...
DEERFIELD, Ill. Walgreens Boots Alliance, Inc. (Nasdaq: WBA) today announces that it has entered into an agreement to reduce its stake in Guangzhou Pharmaceuticals Corporation, a pharmaceutical...
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Clover Biopharmaceuticals Receives CFDA Approval to Initiate Clinical Trials...
CHENGDU, China Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, today announced it has received Clinical Trial Application (CTA)...
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三叶草生物制药获得CFDA临床批件开始在中国进行依那西普生物类似药SCB-808临床试验
成都 三叶草生物制药，一家致力于创新及变革性生物制药研发的生物制药公司，今天宣布已获得中国食品药品监督管理局（CFDA）颁发的临床批件，在中国进行SCB-808预充填小容量注射液Enbrel®（依那西普）生物类似药的临床试验，用于治疗类风湿性关节炎和其他自身免疫性疾病，预计将在2018年中期进入中国I期临床试验。 三叶草生物制药创始人、董事长及总裁梁朋博士表示：“我们非常高兴获得CFDA...
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Dr. Reddy’s Laboratories announces the launch of Melphalan Hydrochloride for...
HYDERABAD, India & PRINCETON, N.J. Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) announced today that it has launched Melphalan Hydrochloride for Injection, a therapeutic...
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Soliris® (Eculizumab) Receives Marketing Authorization in Japan for the...
NEW HAVEN, Conn. Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced today that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Soliris® (eculizumab) as a treatment for...
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Poxel and Sumitomo Dainippon Pharma Announce Initiation of Phase 3 Program...
LYON, France & OSAKA, Japan POXEL SA (Euronext – POXEL – FR0012432516, hereinafter called “Poxel”), a biopharmaceutical company focused on the development of innovative treatments for metabolic...
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