News

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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Teva Pharmaceutical Industries announced that it has completed the divestiture of PARAGARD (intrauterine copper contraceptive) to CooperSurgical in a $1.1 billion cash transaction. This…
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Pharmaceutical Product Development, LLC (PPD) announced it was awarded a seven-year contract under the Clinical Research Support Services (CRSS) program of the Division of AIDS (DAIDS),…
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Aviragen Therapeutics and Vaxart announced that the companies have entered into a definitive merger agreement. The merger will result in a combined company, Vaxart, Inc., focused on…
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Abbott has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for its Alinity™ ci-series instruments for clinical chemistry and immunoassay diagnostics. These innovative…
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AstraZeneca and its haematology research and development centre of excellence, Acerta Pharma, announced that the US Food and Drug Administration (FDA) has granted accelerated approval…
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Medicure International has acquired an exclusive license to sell and market PREXXARTAN (valsartan) oral solution in the United States and its territories from Carmel Biosciences, Inc.…
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MilliporeSigma today announced the signing of a Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologics…
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Novartis announced that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the…
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Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and Glycotope GmbH (hereafter, Glycotope) have signed an option agreement for future strategic collaboration and licensing to…
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Mustang Bio announced that it has entered into a lease agreement with the UMass Medicine Science Park in Worcester, Massachusetts, for a manufacturing facility to support the clinical…
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CMP Pharma announced that CaroSpir® (Spironolactone Oral Suspension, 25 mg/5 mL), the first and only FDA-approved oral liquid dosage form of the potassium-sparing diuretic…
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Incyte Corporation and MedImmune, AstraZeneca’s  global biologics research and development arm, announced the expansion of their clinical collaboration. As part of the agreement, the…
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The U.S. Food and Drug Administration (FDA) has accepted Bayer's Biologics License Application (BLA) filing for BAY94-9027, an extended half-life site-specifically PEGylated recombinant…
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Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the pivotal phase 3 placebo-controlled ENLIVEN (NCT02371369) study of pexidartinib met its primary…
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Novartis announced that the company has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for Kymriah™ (tisagenlecleucel)…
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