Search Results for Regulatory Reconnaissance

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Regulatory Recon: EU Approves Merck, Pfizer's Bavencio; FDA Advises on Opioid Benzo Combo (21 September 2017) By Michael Mezher - Published 21 September 2017

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

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Regulatory Recon: NICE Backs Opdivo for NSCLC After Price Cut; Alnylam RNAi Drug Succeeds in Phase III (20 September 2017) By Michael Mezher - Published 20 September 2017

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

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Regulatory Recon: Bayer Halts Non-US Sales of Essure; FDA Approves GSK's Triple Drug COPD Inhaler (19 September 2017) By Michael Mezher - Published 19 September 2017

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

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Regulatory Recon: Teva Sells Off Remaining Women's Health Assets for $1.38B; Fosun to Buy 74 Percent Stake in Gland Pharma (18 September 2017) By Michael Mezher - Published 18 September 2017

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

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Regulatory Recon: Phase III Cancer Vaccine Trial Fails; EMA’s CHMP Recommends 13 Medicines for Approval (15 September 2017) By Zachary Brennan - Published 15 September 2017

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

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Regulatory Recon: AZ Sells Remaining Anesthetic Rights to Aspen for $766M; FDA Panel Unanimously Backs GSK Shingles Vaccine (14 September 2017) By Michael Mezher - Published 14 September 2017

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

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Regulatory Recon: Amicus Abandons Wound Treatment After Phase III Miss; Mylan Says Allergan Misusing Tribal Sovereignty (13 September 2017) By Michael Mezher - Published 13 September 2017

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

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Regulatory Recon: Alexion Cutting 600 Jobs in Boston HQ Move; Teva Sells Paragard Contraceptive Business for $1.1B (12 September 2017) By Michael Mezher - Published 12 September 2017

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

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Regulatory Recon: Teva Hires Lundbeck's Schultz as CEO; Updates from ESMO (11 September 2017) By Michael Mezher - Published 11 September 2017

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

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Regulatory Recon: Sanofi, Regeneron Get Breakthrough Status for PD-1 Skin Cancer Candidate; New Mexico Sues 8 Opioid Makers and Distributors (8 September 2017) By Michael Mezher - Published 08 September 2017

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

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Regulatory Recon: Eli Lilly to Lay Off 3,500 in Global R&D Cuts; FDA Puts Holds on BMS, Celgene Cancer Trials (7 September 2017) By Michael Mezher - Published 07 September 2017

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

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Regulatory Recon: Merck Buys German Immuno-Oncology Specialist Rigontec; NICE Again Rejects Takeda's Ninlaro for Multiple Myeloma (6 September 2017) By Michael Mezher - Published 06 September 2017

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

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Regulatory Recon: FDA Halts Cellectis' Off-the-Shelf CAR-T Trial After Patient Death; Novartis Names New CEO (5 September 2017) By Michael Mezher - Published 05 September 2017

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

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Regulatory Recon: Dr. Reddy's US Suboxone Patent Win Sends Indivior's Share Price Tumbling; St. Kitts Launches Probe of Controversial Offshore Herpes Vaccine Study (1 September 2017) By Michael Mezher - Published 01 September 2017

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

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Regulatory Recon: Spanish Regulator Ramps Up Hiring Ahead of Brexit; FDA Delays Decision on Biocon, Mylan Herceptin Biosimilar (31 August 2017) By Michael Mezher - Published 31 August 2017

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

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Regulatory Recon: FDA Approves Medicines Co's UTI Antibiotic; Nonprofit Gets PRV for First FDA Approved Chagas Treatment (30 August 2017) By Michael Mezher - Published 30 August 2017

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

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Regulatory Recon: FDA Refuses Acorda's Application for Parkinson's Drug; AZ Offloads Early Stage Drug to Takeda in $400m Co-Development Deal (29 August 2017) By Michael Mezher - Published 29 August 2017

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

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

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Regulatory Recon: Gilead to Buy Kite for CAR-T Pipeline in $12B Deal (28 August 2017) By Michael Mezher - Published 28 August 2017

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

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Regulatory Recon: Samsung, Biogen Humira Biosimilar Approved in Europe; FDA Approves Adamas Parkinson's Dyskinesia Drug (25 August 2017) By Michael Mezher - Published 25 August 2017

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

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Regulatory Recon: Roche Nabs Priority Review for Hemophilia A Drug; Novartis Gets EU Approval for Breast Cancer Drug Kisqali (24 August 2017) By Michael Mezher - Published 24 August 2017

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

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Regulatory Recon: Gottlieb Appoints Sherman as Top Lieutenant; Potential Bidders Emerge for Teva's Women's Health Unit (23 August 2017) By Michael Mezher - Published 23 August 2017

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

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Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017) By Zachary Brennan - Published 22 August 2017

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Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, PMDA, WHO, Drugs, Government affairs, Medical Devices

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Regulatory Recon: Samsung Bioepis and Takeda Team Up for Biologics Development; Hikma Raises Prices of Six US Generics (21 August 2017) By Michael Mezher - Published 21 August 2017

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

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Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017) By Zachary Brennan - Published 17 August 2017

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

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Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer; South Carolina Sues Purdue Over Opioid Marketing (16 August 2017) By Michael Mezher - Published 16 August 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