News

In a small safety trial based on preclinical work by a Stanford researcher, participants receiving blood plasma infusions from young donors showed some evidence of improvement.…
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Spanish pharmaceutical company Almirall opted for Werum’s PAS-X Manufacturing Execution System to be installed in the German plant in Reinbek near Hamburg. Almirall is the market leader…
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The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare…
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Millendo Therapeutics announced positive topline results from a Phase 2 proof-of-concept study of ATR-101 in classic congenital adrenal hyperplasia (CAH), a rare inherited endocrine…
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Torrent Pharmaceuticals Limited and Unichem Laboratories Limited announced that Torrent has entered into a definitive binding agreement with Unichem to acquire its branded business of…
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PharmaMar has announced a licensing agreement with Boryung Pharm to commercialize the marine-derived anticancer drug Zepsyre (lurbinectedin), if approved, in South Korea. Under the…
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TherapeuticsMD announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR, the Company’s investigational applicator-free estradiol vaginal softgel capsule for…
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FUJIFILM Corporation is to invest a total of 3.2 billion yen on its CDMO sites in the U.S.A. and the U.K. in order to accelerate the expansion of the company's business for developing…
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Abbott announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the company's MitraClip device for treatment of people with mitral regurgitation (MR), a…
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Artemis Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for Artemisone, the Company's lead product candidate, for the treatment…
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Janssen Research & Development, LLC (Janssen) announced positive results from a randomized, placebo-controlled Phase 2 study investigating the anti-interleukin (IL)-12/23 monoclonal…
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Stealth BioTherapeutics (Stealth) announced the initiation of MMPOWER-3, a Phase 3 study evaluating the efficacy and safety of daily subcutaneous injections of elamipretide in patients…
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Boehringer Ingelheim and Dicerna Pharmaceuticals announced a research collaboration and license agreement to discover and develop novel GalXC™ RNAi therapeutics for the treatment of…
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The Canadian scientific community gathered in Ottawa this week to engage in a national dialogue on science, technology and innovation policy at the annual Canadian Science Policy…
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Otsuka Pharmaceutical announced detailed results from the Phase 3 REPRISE trial of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD). Trial results…
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WuXi Biologics and its partner Pall Corporation established a joint laboratory to develop full continuous processing for the manufacturing of monoclonal antibodies (mAb). The 3-year…
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Visterra announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead product candidate, VIS410, a novel monoclonal antibody in development…
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RedHill Biopharma together with IntelGenx announced that they have resubmitted the 505(b)(2) New Drug Application (NDA) for RIZAPORT 10mg to the U.S. Food and Drug Administration (FDA).…
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Almac Group announced the acquisition of 100% shares of BioClin Laboratories, an independent and privately owned organisation based in Athlone, Ireland. Established in 2002 and…
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TraceLink announced that Spanish-based pharmaceutical manufacturer, Normon Laboratories, has selected TraceLink's serialization solutions to comply with the EU Falsified Medicines…
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