Industry News

First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

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

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisationin the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

  • Posted on: 1 March 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

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.