Search Results for FDA News

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

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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

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Regulatory Recon: FDA Approves New Rheumatoid Arthritis Treatment; Alexion C-Suite Overhaul (23 May 2017) By Zachary Brennan - Published 23 May 2017

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

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Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017) By Zachary Brennan - Published 22 May 2017

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Categories: News, Asia, Canada, Europe, Latin America and Caribbean, US, FDA, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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Regulatory Recon: House Committee Schedules FDA Budget Hearing; Janssen Sues to Block Samsung Bioepis' Remicade Biosimilar (19 May 2017) By Michael Mezher - Published 19 May 2017

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

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Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) By Zachary Brennan - Published 18 May 2017

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Categories: Canada, Europe, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: Former FDA Commissioner Califf Gets New Role at Verily; FDA Puts Hold on Concert Hair Loss Drug Study (17 May 2017) By Michael Mezher - Published 17 May 2017

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Regulatory Recon: Editas Delays CRISPR Cas9 Human Study; AstraZeneca Sues Former Exec After Leaving for GSK (16 May 2017) By Michael Mezher - Published 16 May 2017

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Regulatory Recon: Thermo Fisher to Buy Patheon for $7.2B; EC Opens Formal Antitrust Investigation Into Aspen's Pricing Practices (15 May 2017) By Michael Mezher - Published 15 May 2017

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Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

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

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Regulatory Recon: FDA Approves Keytruda in Combination with Chemo for Lung Cancer; Pfizer and Sangamo Strike Hemophilia Deal (11 May 2017) By Michael Mezher - Published 11 May 2017

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Regulatory Recon: Roche's Tecentriq Fails in Phase III; PhRMA Cuts 22 Members (10 May 2017) By Michael Mezher - Published 10 May 2017

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Regulatory Recon: J&J Discloses Federal Probes; House Committee Questions Companies, DEA Over Opioid Dumping in WV (9 May 2017) By Michael Mezher - Published 09 May 2017

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Regulatory Recon: FDA Approves First ALS Drug in Two Decades; Kite Discloses Patient Death in CAR-T Study (8 May 2017) By Michael Mezher - Published 08 May 2017

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Regulatory Recon: EMA, EC Release Biosimilars Information Guide; NICE Rejects Orexigen Weight-Loss Drug (5 May 2017) By Michael Mezher - Published 05 May 2017

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Regulatory Recon: Novartis, Roche Back French Gene Therapy Startup; Pfizer to Give Patients Free Access to Breast Cancer Drug as it Awaits NICE Decision (4 May 2017) By Michael Mezher - Published 04 May 2017

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Regulatory Recon: Former FDA Commissioner Califf Offers Advice to Gottlieb; DoJ Raids Perrigo in Price Fixing Probe (3 May 2017) By Michael Mezher - Published 03 May 2017

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Regulatory Recon: AstraZeneca's Durvalumab Gets First Bladder Cancer Approval; Pfizer, Merck Beat Q1 Profit Estimates (2 May 2017) By Michael Mezher - Published 02 May 2017

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Regulatory Recon: FDA Approves Takeda's Alunbrig as Second Line Lung Cancer Treatment; Neurotrope Alzheimer's Drug Data Disappoints (1 May 2017) By Michael Mezher - Published 01 May 2017

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Regulatory Recon: FDA Approves Novartis' Rydapt for AML; Questions Raised Over UK Cancer Drugs Fund (28 April 2017) By Michael Mezher - Published 28 April 2017

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

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Regulatory Recon: Criteria for New EMA Host Coming Saturday; Concerns Raised About Integrity of International Trials (27 April 2017) By Michael Mezher - Published 27 April 2017

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

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Regulatory Recon: India Antitrust Regulator Probes Roche Over Herceptin; GSK CEO Walmsley Says Pharma is Top Priority (26 April 2017) By Michael Mezher - Published 26 April 2017

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

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Regulatory Recon: Fresenius to Buy Akorn, German Merck's Biosimilar Busienss; After Trial Failures OncoMed Cuts Half its Staff (25 April 2017) By Michael Mezher - Published 25 April 2017

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Regulatory Recon: BD to Acquire Bard for $24B; WHO to Pilot GSK Malaria Vaccine (24 April 2017) By Michael Mezher - Published 24 April 2017

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

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