Search Results for Regulatory News

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Regulatory Recon: AstraZeneca Immunotherapy Fails in Lung Cancer Study; FDA Panel Votes Against Intelli's Long Acting Opioid (27 July 2017) By Michael Mezher - Published 27 July 2017

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

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Regulatory Recon: Celgene to Pay $280M to Settle Off-Label Promotion Suit; GSK Calls for at Least Two-Years' Brexit Transition (26 July 2017) By Michael Mezher - Published 26 July 2017

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

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Regulatory Recon: AbbVie Ordered to Pay $150M in AndroGel Suit; Stada Board Accepts Bain, Cinven's Latest Takeover Offer (25 July 2017) By Michael Mezher - Published 25 July 2017

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

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Regulatory Recon: Mitsubishi Tanabe Buys NeruoDerm for $1.1B; FDA Reviewers Raise Concerns About Intelli's Long-Acting Opioid Ahead of Panel (24 July 2017) By Michael Mezher - Published 24 July 2017

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

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Regulatory Recon: Trump Showcases Corning Drug Packaging Investment; MHRA To Relocate Near EMA's Current Offices (21 July 2017) By Michael Mezher - Published 21 July 2017

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

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Regulatory Recon: NICE Gives Final OKs to Amgen's Kyprolis, Teva's Cinqaero; Ablynx, Sanofi Sign Immunology Deal Worth Up to $2.8B (20 July 2017) By Michael Mezher - Published 20 July 2017

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

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Regulatory Recon: Vertex Three Drug Cystic Fibrosis Combos Beat Expectations; FDA Approves Gilead's Vosevi for 2nd Line HCV Treatment (19 July 2017) By Michael Mezher - Published 19 July 2017

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

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Regulatory Recon: FDA Approves Puma's Breast Cancer Drug Nerlynx; US Court Upholds Takeda Patent on Velcade (18 July 2017) By Michael Mezher - Published 18 July 2017

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

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Regulatory Recon: FDA Accepts Spark's Gene Therapy Application; Amgen Gets CRL for Osteoporosis Candidate Evenity (17 July 2017) Published 17 July 2017

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Regulatory Recon: J&J Uses Priority Review Voucher to Speed Psoriasis Approval; DoJ Charges 412 in Healthcare, Opioid Schemes (14 July 2017) By Michael Mezher - Published 14 July 2017

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Regulatory Recon: Amgen's Blincyto Wins Full FDA Approval; NICE Backs Three Drugs for Plaque Psoriasis in Children (13 July 2017) By Michael Mezher - Published 13 July 2017

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Regulatory Recon: FDA Rejects Drug Over Manufacturing Issues; Advisory Panel Backs Pfizer’s Mylotarg (12 July 2017) By Zachary Brennan - Published 12 July 2017

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

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Regulatory Recon: FDA Reverses on Amicus’ Fabry Disease Treatment; Sanofi Acquires Protein Sciences (11 July 2017) By Zachary Brennan - Published 11 July 2017

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

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Regulatory Recon: FDA Panel to Focus on Safety of CAR-T Therapy (10 July 2017) By Zachary Brennan - Published 10 July 2017

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Categories: News, Europe, US, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: UK Supreme Court Rules in Favor of Lilly Patents; HHS OIG Probes Alexion (7 July 2017) By Zachary Brennan - Published 07 July 2017

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

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Regulatory Recon: FDA Halts Three Keytruda Studies After Patient Deaths; Euro Biotech Firms Raised $2.3B in First Half of 2017 (6 July 2017) By Michael Mezher - Published 06 July 2017

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

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Regulatory Recon: NICE Expands Access to Strensiq; Stada Execs Step Down as Bain, Cinven Prepare New Bid (5 July 2017) By Michael Mezher - Published 05 July 2017

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

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Regulatory Recon: Canada Supreme Court Hands Patent Victory to Pharma; GSK Signs $43m AI Drug Discovery Deal (3 July 2017) By Michael Mezher - Published 03 July 2017

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

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Regulatory Recon: Pfizer's Besponsa Gets EU Approval; Roche Buys Diabetes App Firm (30 June 2017) By Michael Mezher - Published 30 June 2017

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

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Regulatory Recon: World Bank Launches Pandemic Bond; Final NICE OK for Sanofi Gaucher Drug (29 June 2017) By Michael Mezher - Published 29 June 2017

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

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Regulatory Recon: Merck Hit in Global Ransomware Attack; Califf Shares Ideas on Real World Evidence (28 June 2017) By Michael Mezher - Published 28 June 2017

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

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Regulatory Recon: Merck Cholesterol Drug Surprises With Phase III Success; Bain and Cinven's €4.1B Stada Buyout Falls Through (27 June 2017) By Michael Mezher - Published 27 June 2017

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

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Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017) By Michael Mezher - Published 26 June 2017

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

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Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017) By Michael Mezher - Published 23 June 2017

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

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Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017) By Michael Mezher - Published 22 June 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

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