Pharma News

FDA warns patients and doctors about recall of home-use test strips used with device to monitor blood thinner warfarin, not authorized for sale in U.S.

  • Posted on: 4 February 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. The FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.

EMA committee recommended for the first time an adjunct treatment to insulin (tablet form) for certain patients with type 1 diabetes mellitus

  • Posted on: 4 February 2019
  • By: Shalini.Sharma

EMA’s human medicines committee (CHMP) has recommended for the first time an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus.

EMA launching Public consultation on key principles for the electronic product information of EU medicines

  • Posted on: 2 February 2019
  • By: Shalini.Sharma

EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching  six-month public consultation on draft key principles which will form the basis on which the electronic product information (ePI) for human medicines will be developed and used in the European Union.

Some gut cells slow down metabolism, accelerate cardiovascular disease: Study

  • Posted on: 2 February 2019
  • By: Shalini.Sharma

Researchers have discovered how specific cells in the guts of mice slow down metabolism and eventually contribute to obesity, diabetes, hypertension and atherosclerosis. The findings, scientists say, could have important implications for the prevention and treatment of these kinds of metabolic diseases in humans. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health and appears in the journal Nature.

The future of minority health and health disparities research is here: NIH

  • Posted on: 2 February 2019
  • By: Shalini.Sharma

Health disparities have persisted, despite extensive research and a decades-long mandate to eliminate them. Thus, the National Institute on Minority Health and Health Disparities (NIMHD) led a National Institutes of Health-wide, two-year science visioning process to chart a new research course to improve minority health and reduce health disparities. The American Journal of Public Health (AJPH) special issue  New Perspectives to Advance Minority Health and Health Disparities Research, is the culmination of this process with input from experts to help NIH determine the science needed to address health disparities. Thirty specific research strategies were identified across the three pillars that guided the science visioning: methods and measurement, etiology, and interventions.

Nicox announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis

  • Posted on: 30 January 2019
  • By: PharmaTutor News

Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.  The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.

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