Search Results for FDA News

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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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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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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

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

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Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017) By Michael Mezher - Published 21 June 2017

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Regulatory Recon:  Pamplona to Buy CRO Parexel for $5B; FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017) By Michael Mezher - Published 20 June 2017

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Regulatory Recon: Seattle Genetics Halts Trials Due to Patient Deaths; Novartis' Rituxan Biosimilar Gets EU Approval (19 June 2017) By Michael Mezher - Published 19 June 2017

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Regulatory Recon: Adamis Wins FDA Approval for EpiPen Rival; BMS to Sell Ireland API Plant to SK Biotek (16 June 2017) By Michael Mezher - Published 16 June 2017

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Regulatory Recon: Google, Novartis Back Medicxi's $300M Biotech Fund; China's Rise in Biotech (15 June 2017) By Michael Mezher - Published 15 June 2017

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Regulatory Recon: NICE Rejects Pfizer's Besponsa for ALL; Sanofi to Increase Investment in Biologics Production (14 June 2017) By Michael Mezher - Published 14 June 2017

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Regulatory Recon: Merck Pauses Two Keytruda Studies After Patient Deaths; Pfizer, Roche & Aspen Face South Africa Pricing Probe (13 June 2017) By Michael Mezher - Published 13 June 2017

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Regulatory Recon: FDA Rejects Coherus' Neulasta Biosimilar; Chi-Med Seeks CFDA Approval for Cancer Drug (12 June 2017) By Michael Mezher - Published 12 June 2017

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Regulatory Recon: Japan Scraps Drug Price Cut Proposal; NICE Rejects Zurampic for Hyperuricemia in Gout Patients (9 June 2017) By Michael Mezher - Published 09 June 2017

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Regulatory Recon: Valeant to Sell Pharma Unit for $930M; South Korea to Fine Novartis Over Drug Promos (8 June 2017) By Zachary Brennan - Published 08 June 2017

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

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Regulatory Recon: Valeant in Talks to Sell Eye-Surgery Assets to Carl Zeiss; Trump Will Keep Collins as NIH Director (7 June 2017) By Michael Mezher - Published 07 June 2017

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Regulatory Recon: House E&C Committee to Vote on User Fee Reauthorization Wednesday; FDA Approves Valve-in-Valve Use for Edwards' Sapien 3 Valves (6 June 2017) By Michael Mezher - Published 06 June 2017

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Regulatory Recon: Loxo's Targeted Cancer Drug Sees High Response Rate & More News From ASCO17 (5 June 2017) By Michael Mezher - Published 05 June 2017

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Regulatory Recon: ViiV, GSK Use Priority Review Voucher for 2-Drug HIV Combo; NICE Backs Opdivo for Classical Hodgkin Lymphoma (2 June 2017) By Michael Mezher - Published 02 June 2017

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Regulatory Recon: Ohio Sues Five Drugmakers Over Opioid Epidemic; Tesaro Reportedly Exploring Sale (1 June 2017) By Michael Mezher - Published 01 June 2017

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Regulatory Recon: FDA Approves First Strattera Generics; UK’s NICE Backs Keytruda (31 May 2017) By Zachary Brennan - Published 31 May 2017

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Categories: News, Asia, Europe, US, EMA, FDA, Health Canada, NICE, TGA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

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Regulatory Recon: Amgen Sues FDA Over Sensipar Pediatric Exclusivity; Congo Clears Use of Merck Ebola Vaccine in Latest Outbreak (30 May 2017) By Michael Mezher - Published 30 May 2017

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Regulatory Recon: Kite CAR-T Therapy Nabs FDA Priority Review; UnitedHealth, Merck Sign Pact to Explore Value-Based Payments (26 May 2017) By Michael Mezher - Published 26 May 2017

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Regulatory Recon: GW Set to File Cannabis-Based Epilepsy Drug; Roche, Biogen Looking Into Report of Rare Brain Infection in MS Patient (25 May 2017) By Michael Mezher - Published 25 May 2017

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Regulatory Recon: FDA Panel Backs Puma Breast Cancer Drug; Biogen MS Drug Fampyra Picks up Full EU Approval (24 May 2017) By Michael Mezher - Published 24 May 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