About Cyndi Root

Cyndi Root is a contributing writer for Life Science Connect who writes regular life sciences news features for several markets. She has a Bachelor’s degree from Yale University.

ARTICLES BY CYNDI ROOT

  • Weekly FDA Enforcement Report For Drugs 8/20/14 The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 13, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action.
  • U.K.’s NICE To Re-Review Ferring’s Firmagon Ferring Pharmaceuticals confirmed the U.K.’s National Institute for Health and Care Excellence (NICE) Appeals Panel has upheld Ferring’s appeal regarding Firmagon (degarelix). The panel listened to Ferring’s oral arguments at a hearing in London and agreed that the agency’s Final Appraisal Determination (FAD) was improper. Appeals by the British Uro-Oncology Group (BUG) and Tackle Prostate Cancer were also upheld.
  • Medicines New Zealand Strengthens Social Media Guidance Medicine’s New Zealand, an industry association, announced in a press release that it has updated its Code of Practice and strengthened its social media guidance. PHARMAC (Pharmaceutical Management Agency), the government agency that authorizes payment for treatments, stated that the update reflected feedback from the pharmaceutical sector, including itself.
  • UK’s NICE Recommends Gilead’s Sovaldi For Hepatitis C

    The National Institute for Health and Care Excellence (NICE) in the U.K. announced in a press release that it has recommended Gilead’s Sovaldi (sofosbuvir) for Hepatitis C treatment. The medication has been under intense scrutiny due to its high cost of $84,000 for a 12-week regimen. The Wall Street Journal reports that NICE often denies financial coverage for medications and “often butted heads with drug makers and patient groups over its decisions.” After asking Gilead for more information, the U.K. agency decided that Sovaldi was an improvement over existing treatments, and the selling cost of $54,000 in the U.K. may have swayed its decision.

  • Weekly FDA Enforcement Report For Drugs 8/13/14

    The Food and Drug Administration (FDA) has released its Drug product Enforcement Report for August 13, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Classification, the danger level. 

  • FDA Issues New Biosimilars Draft Guidance Providing Increased Exclusivity Rights The Food and Drug Administration (FDA) announced in the Federal Register that it has issued a new biosimilars draft guidance. The draft guidance assists biologics sponsors in submitting information that helps the FDA to determine the first licensing date of a reference product under the Public Health Service Act (PHS Act).
  • Weekly FDA Enforcement Report For Drugs And Biologics 7/30/14 The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for July 30, 2014. The agency publicizes recalls in its weekly report as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. View the recalls by Biologics or Drugs, and by Classification.
  • Thomson Reuters Recognizes World Hepatitis Day With Report On HCV Drugs Thomson Reuters has prepared a report and an infographic on the Hepatitis drug market in recognition of World Hepatitis Day. The data and commentary highlights the drug classes used against hepatitis C virus (HCV), the state of HCV drug development, and the industry players boasting new drugs — including Gilead’s Sovaldi, Roche’s mericitabine, and Bristol-Myers Squibb’s daclatasvir- based therapies. Also addressed are the costs of the new drugs, which have shocked insurance companies, patients, and legislators.
  • Merck KGaA Targets Chinese Market, Builds New Shanghai Manufacturing Facility

    Merck KGaA announced in a press release that it is strengthening its commitment to the Chinese market as part of its overall strategy to target emerging markets.

  • Hikma Acquires Ben Venue Generic Injectables Manufacturing Facility In Ohio

    Hikma Pharmaceuticals PLC announced in a press release that it has acquired the Ben Venue Laboratories manufacturing facility in Bedford, OH. Ben Venue is part of Boehringer Ingelheim, and its generic injectables manufacturing site includes four manufacturing plants and a Quality and Development Centre (QDC).

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