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Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 2017) By Michael Mezher - Published 24 March 2017

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

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Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 2017) By Michael Mezher - Published 23 March 2017

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

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Regulatory Recon: FDA Approves Newron's  Xadago as Add-On for Parkinson's Disease; Novartis Heart Drug Serelaxin Fails in Phase III Trial (22 March 2017) By Michael Mezher - Published 22 March 2017

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

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Regulatory Recon: Array Withdraws Binimetinib Application Ahead of Advisory Committee; Amgen Submits Herceptin Biosimilar for EU Approval (21 March 2017) By Michael Mezher - Published 21 March 2017

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

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Regulatory Recon: China Looks to Speed Approvals for Imported Drugs; Highlights from ACC17 (20 March 2017) By Michael Mezher - Published 20 March 2017

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

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Regulatory Recon: Amgen Cholesterol Drug Data Disappoints Investors; German Drugmaker Stada Stokes Private Equity Bidding War (17 March 2017) By Michael Mezher - Published 17 March 2017

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

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Regulatory Recon: PTC to Buy Marathon's Emflaza; NICE Cleared to Fast Track More Approvals (16 March 2017) By Michael Mezher - Published 16 March 2017

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Regulatory Recon: Merck's Keytruda Gets FDA Nod for Hodgkin Lymphoma; FDA Panel Says Opana Risks Outweigh Benefits (15 March 2017) By Michael Mezher - Published 15 March 2017

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Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017) By Zachary Brennan - Published 14 March 2017

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Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, Health Canada, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

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Regulatory Recon: Roche and Mylan Settle Dispute Over Herceptin Biosimilar; EMA Suspends Marketing of Four Contrast Agents for MRI Images (13 March 2017) By Zachary Brennan - Published 13 March 2017

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Categories: News, Canada, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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Regulatory Recon: Results From CRISPR Gene Editing of Embryos (10 March 2017) By Zachary Brennan - Published 10 March 2017

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

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Regulatory Recon: Democrats Say Trump 'Enthusiastic' on Drug Cost Proposal; Novo Nordisk Reportedly in Bid to Buy Global Blood Therapeutics (9 March 2017) By Michael Mezher - Published 09 March 2017

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Regulatory Recon: Amgen Gets NICE Backing for Parsabiv; House Committees Begin Healthcare Bill Markup (8 March 2017) By Michael Mezher - Published 08 March 2017

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Regulatory Recon: House Republicans Unveil Plan to Replace Obamacare; PTC Files DMD Drug Over Protest With FDA (7 March 2017) By Michael Mezher - Published 07 March 2017

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Regulatory Recon: UK High Court Invalidates Humira Patents; Germany to Abandon Plans to Lower Prices of New Drugs (6 March 2017) By Michael Mezher - Published 06 March 2017

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Regulatory Recon: Actavis, Concordia Accused of Price Fixing; Former FDA Commissioner Weighs in on Approval Process (3 March 2017) By Michael Mezher - Published 03 March 2017

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Regulatory Recon: Juno Abandons Lead CAR-T Candidate After Patient Deaths; Trump to Meet With Cummings on Drug Pricing (2 March 2017) By Michael Mezher - Published 02 March 2017

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Regulatory Recon: FDA Approves Lexicon's Xermelo; GRAIL Raises $900M to Develop Cancer Tests (1 March 2017) By Michael Mezher - Published 01 March 2017

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Regulatory Recon: Kite CAR-T Drug Hits Primary Endpoint in NHL Study; Trump's 2018 Budget Would Cut Basic Science Spending by 10% (28 February 2017) By Michael Mezher - Published 28 February 2017

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Regulatory Recon: La Jolla Low Blood Pressure Drug Succeeds in Phase III Shock Study; WHO Calls for Drugs Needed for 12 'Priority Pathogens' (27 February 2017) By Michael Mezher - Published 27 February 2017

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Regulatory Recon: CHMP Recommends Six Medicines for Approval; FDA Panel Backs Sentinel Cerebral Protection System (24 February 2017) By Michael Mezher - Published 24 February 2017

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

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Regulatory Recon: First Biosimilar Cancer Treatment Approved in EU; Allergan CEO Pushes for Trump to Lead Pricing Talks (23 February 2017) By Michael Mezher - Published 23 February 2017

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

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Regulatory Recon: PhRMA CEO Says FDA Review Process Should Remain the 'Gold Standard'; BMS Takeover Rumors Rise After Icahn Buys Stake (22 February 2017) By Michael Mezher - Published 22 February 2017

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

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Regulatory Recon: Amphastar Hit With CRL for Intranasal Nalaxone; NICE Rejects Ipsen's Cabometyx in Draft Guideline (21 February 2017) By Michael Mezher - Published 21 February 2017

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

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Regulatory Recon: FDA Warns Pfizer's Kansas Site; AstraZeneca Sells Zoladex Rights for $250M (20 February 2017) By Michael Mezher - Published 20 February 2017

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

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