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Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results; Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017) By Michael Mezher - Published 20 November 2017

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

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Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro; Takeda CEO Eyes Deals Outside Japan (17 November 2017) By Michael Mezher - Published 17 November 2017

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

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Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra; Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 2017) By Michael Mezher - Published 16 November 2017

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

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Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex; Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017) By Michael Mezher - Published 15 November 2017

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Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017) By Michael Mezher - Published 14 November 2017

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

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Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D; J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017) By Michael Mezher - Published 13 November 2017

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

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Regulatory Recon: FDA Approves Dynavax's Hep B Vaccine; BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017) By Michael Mezher - Published 10 November 2017

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

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Regulatory Recon: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals; FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017) By Michael Mezher - Published 09 November 2017

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

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Regulatory Recon: Ohio Drug Pricing Ballot Initiative Fails; NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017) By Michael Mezher - Published 08 November 2017

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Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers; Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017) By Michael Mezher - Published 07 November 2017

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Regulatory Recon: Valeant to Sell Sprout Back to Former Owners; Novartis Submits Kymriah for EU Review (6 November 2017) By Michael Mezher - Published 06 November 2017

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Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta; Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017) By Michael Mezher - Published 03 November 2017

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Regulatory Recon: Teva Warns on Profit Outlook; Hospitals Vow to Keep Medicare Drug Subsidies (2 November 2017) By Zachary Brennan - Published 02 November 2017

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Categories: News, Canada, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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Regulatory Recon: Bayer, Novartis Fight With UK Doctors Over Avastin Use for AMD; OPDP Enforcement Letters at Record Low (1 November 2017) By Michael Mezher - Published 01 November 2017

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Regulatory Recon: States Seek to Expand Generic Price Fixing Suit to 18 Companies; Pfizer Beats Profit Estimates in Q3 (31 October 2017) By Michael Mezher - Published 31 October 2017

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Regulatory Recon: Novartis to Buy French Drugmaker AAA for $3.9B; Merck Withdraws EU Application for Keytruda in NSCLC (30 October 2017) By Michael Mezher - Published 30 October 2017

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Regulatory Recon: CVS Makes $66B Bid for Aetna; Endo Sues FDA Over Compounding Rules (27 October 2017) By Michael Mezher - Published 27 October 2017

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

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Regulatory Recon: Purdue Under Investigation Over OxyContin Claims; GSK to Build EU Drug Testing Facility as Brexit Contingency (26 October 2017) By Michael Mezher - Published 26 October 2017

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

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Regulatory Recon: GSK Eyes Pfizer, Merck Consumer Units; Sanofi Sues Mylan Over Insulin Pen (25 October 2017) By Michael Mezher - Published 25 October 2017

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

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Regulatory Recon: FDA Approves Expanded Use for Alexion's Soliris; Novartis Preparing for 2019 Sale of Alcon Unit (24 October 2017) By Michael Mezher - Published 24 October 2017

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Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

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Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017) By Zachary Brennan - Published 20 October 2017

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Categories: News, Europe, US, EMA, FDA, NICE

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Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017) By Zachary Brennan - Published 19 October 2017

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Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: Former Lilly Exec Said to be Front Runner for HHS Secretary; Alnylam Partners With Vir on RNAi Hep B Treatment (18 October 2017) By Michael Mezher - Published 18 October 2017

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

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Regulatory Recon: J&J Halts Two Drugs in Development; Novartis to Close Colorado Manufacturing Site (17 October 2017) By Zachary Brennan - Published 17 October 2017

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

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