Industry News

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

  • Posted on: 22 February 2019
  • By: Shalini.Sharma

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.

FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices

  • Posted on: 15 February 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration  permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.

Industry veterans, health experts and policymakers from 25 countries to participate at Medical Fair India

  • Posted on: 7 February 2019
  • By: PharmaTutor News

The Indian healthcare sector is diversifying rapidly and new opportunities are emerging in every segment. This has made India very critical in the current global healthcare scenario. Foreign investments have made the medical devices market a fast moving sector contributing significantly to the GDP. In its endeavor to fuel this growth and present a plethora of opportunities for Indian healthcare space to connect with the medical world, exchange ideas, invest and explore new growth avenues, Medical Fair India is back with it’s 25th edition. Medical Fair India (MFI) 2019 is slated to be held from 21st - 23rd February at Pragati Maidan in New Delhi.

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.

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.

Investigational monoclonal antibody to treat Ebola is safe in adults : NIH

  • Posted on: 30 January 2019
  • By: Shalini.Sharma

The investigational Ebola treatment mAb114 is safe, well-tolerated, and easy to administer, according to findings from an early-stage clinical trial published in The Lancet. Eighteen healthy adults received the monoclonal antibody as part of a Phase 1 clinical trial that began in May 2018 at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center (VRC), part of NIH, developed the investigational treatment and conducted and sponsored the clinical trial.

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