Search Results for EMA News

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Regulatory Recon: Government Shutdown Looms; First PARP Inhibitor Approved in Japan (19 January 2018) By Zachary Brennan - Published 19 January 2018

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Categories: News, EC, FDA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Kite Teams Up With Pfizer on Lymphoma Combo; Fed Up With Drugmakers, Hospitals Start Their Own (18 January 2018) By Michael Mezher - Published 18 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Celgene in Talks to Buy Juno; Chinese Investors Eye J&J's Diabetes Business (17 January 2018) By Michael Mezher - Published 17 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial; Sandoz Files Humira Biosimilar for US Approval (16 January 2018) By Michael Mezher - Published 16 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Google Backs UK Universal Vaccine Company; Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018) By Michael Mezher - Published 15 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation; Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018) By Michael Mezher - Published 12 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Panel Votes Against Testosterone Therapies; Endo Subpoenaed for Opioid Information (11 January 2018) By Michael Mezher - Published 11 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Bluebird Planning for First Three Approvals by 2019; EU Approves Vertex' Orkambi for Younger Patients (10 January 2018) By Michael Mezher - Published 10 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Lilly CEO Says Tax Reform May Boost Pharma Deal Making; 50 Top Managers Replaced at GSK in Walmsley's 1st Year (9 January 2018) By Michael Mezher - Published 09 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Celgene to Buy Impact Biomedicines for Up to $7B; Ablynx Rejects Novo's $3.1B Bid (8 January 2018) By Michael Mezher - Published 08 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Expands Use of Amgen's Fracture Prevention Drug Xgeva; Takeda Signs Alzheimer's Pact With Denali, Strikes Deal to Acquire TiGenix (5 January 2018) By Michael Mezher - Published 05 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Pfizer Signs $830M Discovery Pact with Arvinas; Philippines Fines Sanofi, Pulls Dengvaxia Registration (4 January 2018) By Michael Mezher - Published 04 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Spark Prices Gene Therapy at $850,000; WHO Prequalifies Typhoid Vaccine (3 January 2018) By Michael Mezher - Published 03 January 2018

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018) By Zachary Brennan - Published 02 January 2018

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Categories: News, Asia, Europe, US, FDA, MHRA, TGA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Roche Buys Cancer Specialist Ignyta for $1.7B; FDA Approves La Jolla's Low Blood Pressure Drug (22 December 2017) By Michael Mezher - Published 22 December 2017

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Regulatory Recon: United Therapeutics Settles US Kickback Probe for $210M; Roche Wins US, EU Cancer Approvals (21 December 2017) By Michael Mezher - Published 21 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Legal Experts Question Alternative 510(k) Pathway; France Fines J&J Over Painkiller Patch (20 December 2017) By Michael Mezher - Published 20 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves Aerie's Glaucoma Drug; US Lifts Funding Ban on High Risk Virus Research (19 December 2017) By Michael Mezher - Published 19 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Whistleblowers Say DEA Went Easy on McKesson; Ultragenyx Sells PRV to Novartis for $130M (18 December 2017) By Michael Mezher - Published 18 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Lifts Hold on Alnylam Hemophilia Trials; EMA Recommends 7 New Medicines for EU Approval (15 December 2017) By Michael Mezher - Published 15 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients; Teva to Cut 14,000 Jobs (14 December 2017) By Michael Mezher - Published 14 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017) By Michael Mezher - Published 13 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 2017) By Michael Mezher - Published 12 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

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Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 2017) Published 11 December 2017

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Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017) By Michael Mezher - Published 08 December 2017

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Categories: News, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News