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RedHill Biopharma and IntelGenx submits NDA to FDA for RIZAPORT for Migraines

Nov 2, 2017
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 Announces Acquisition of BioClin Laboratories

Nov 2, 2017
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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Normon selects TraceLink to comply with EU FMD Serialization Regulations

Nov 2, 2017
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 Announces Completion of PARAGARD Divestiture to CooperSurgical

Nov 2, 2017
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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PPD awarded NIH Contract for Clinical Research Support Services

Nov 1, 2017
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 enter into Merger Agreement

Nov 1, 2017
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 announces FDA clearance for its Alinity ci-series diagnostic systems

Nov 1, 2017
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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FDA approves AstraZeneca’s Calquence for treatment of adult patients with MCL

Nov 1, 2017
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 acquires License to Sell and Market PREXXARTAN in the U.S. from Carmel

Nov 1, 2017
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 and Samsung BioLogics to Extend Strategic Alliance

Nov 1, 2017
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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