Search Results for FDA News

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Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 2017) By Michael Mezher - Published 13 December 2017

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Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 2017) By Michael Mezher - Published 12 December 2017

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Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 2017) Published 11 December 2017

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Regulatory Recon: Trump Signs Short-Term Funding Bill Averting Shutdown; Philippines Seeks $59M Refund for Sanofi Dengue Vaccine (8 December 2017) By Michael Mezher - Published 08 December 2017

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Regulatory Recon: Sage Rises as Depression Drug Succeeds in Phase II; Edwards to Buy Harpoon for $250M (7 December 2017) By Michael Mezher - Published 07 December 2017

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Regulatory Recon: FDA Approves Novo Nordisk's Diabetes Drug Ozempic; Australian Competition Watchdog Sues GSK, Novartis Over Pain Relief Marketing (6 December 2017) By Michael Mezher - Published 06 December 2017

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Regulatory Recon: Galectin Plummets After NASH Candidate Fails in Phase IIb Trial; Montana Sues Purdue Over Opioid Epidemic (5 December 2017) By Michael Mezher - Published 05 December 2017

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Regulatory Recon: CVS to Buy Aetna for $69B; FDA Approves Heart Protection Claims for Amgen's Repatha (4 December 2017) By Michael Mezher - Published 04 December 2017

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Regulatory Recon: Astellas Acquires MitoBridge in $450M Deal; National Academy of Sciences Report Lays Out Steps to Cut Drug Prices (1 December 2017) By Michael Mezher - Published 01 December 2017

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Regulatory Recon: Promising Phase III Results for Novartis, Teva Migraine Drugs; Sanofi Expects $120m Hit Over Dengue Vaccine Safety Issues (30 November 2017) By Michael Mezher - Published 30 November 2017

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Regulatory Recon: Melinta Buys Medicines Co's Infectious Disease Business; Bluebird Buys Facility to Make Viruses for Gene Therapy Delivery (29 November 2017) By Michael Mezher - Published 29 November 2017

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Regulatory Recon: Gilead Prices Sovaldi in China at One Fifth US Cost; NICE Turns Down Early Use of Eisai's Halaven (28 November 2017) By Michael Mezher - Published 28 November 2017

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Regulatory Recon: Merck to Invest £1B in New UK Research Hub; Teva Overhauls Management in Restructuring Effort (27 November 2017) By Michael Mezher - Published 27 November 2017

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Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results; Bayer Signs Development Deal with Japan's PeptiDream (20 November 2017) By Michael Mezher - Published 20 November 2017

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Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro; Takeda CEO Eyes Deals Outside Japan (17 November 2017) By Michael Mezher - Published 17 November 2017

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Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra; Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 2017) By Michael Mezher - Published 16 November 2017

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Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex; Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 2017) By Michael Mezher - Published 15 November 2017

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Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 2017) By Michael Mezher - Published 14 November 2017

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Regulatory Recon: Gates Makes $100M Investment in Alzheimer's R&D; J&J, Zymeworks Enter Potential $1B Discovery Pact (13 November 2017) By Michael Mezher - Published 13 November 2017

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Regulatory Recon: FDA Approves Dynavax's Hep B Vaccine; BMS' Sprycel Approved for Pediatric Ph+ CML (10 November 2017) By Michael Mezher - Published 10 November 2017

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Regulatory Recon: Sage Shares Soar After Postpartum Depression Drug Meets Phase III Goals; FDA Approves Merck Drug to Prevent Post-Stem Cell Transplant Infections (9 November 2017) By Michael Mezher - Published 09 November 2017

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Regulatory Recon: Ohio Drug Pricing Ballot Initiative Fails; NICE Rejects Bayer's Stivarga for Liver Cancer (8 November 2017) By Michael Mezher - Published 08 November 2017

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Regulatory Recon: FDA Approves Roche Drugs for Rare Blood and Lung Cancers; Sen. Harris Questions Alkermes' Vivitrol Promotion Tactics (7 November 2017) By Michael Mezher - Published 07 November 2017

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Regulatory Recon: Valeant to Sell Sprout Back to Former Owners; Novartis Submits Kymriah for EU Review (6 November 2017) By Michael Mezher - Published 06 November 2017

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Regulatory Recon: FDA Approves Valeant's Glaucoma Drug Vyzulta; Former GSK Head Witty to Lead UK Accelerated Access Scheme (3 November 2017) By Michael Mezher - Published 03 November 2017

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