- Medtech Europe: Council and Parliament representatives confirm agreement on medical device and IVD regulations
As reported in a press release posted on the website of Medtech Europe, the medical technology industry welcomed the vote on the consolidated medical device and in vitro diagnostics (IVD) regulation texts by representatives of the Council and the Parliament.
- ABPI embraces opportunity to collaborate with local National Health Service (NHS) stakeholders and patient groups to ensure the appropriate use of biosimilar medicines
The Association of the British Pharmaceutical Industry (ABPI) welcomed NHS England’s new publication summarising the recent regional workshops held on biosimilar medicines.
- US regulators have widen the use of Boehringer Ingelheim and Elli Lilly's medicine Synjardy, to include treatment-naive adults with type 2 diabetes
Synjardy is a combination of empagliflozin (marketed as Jardiance) and metformin - two medicines with complementary mechanisms of action - to help control blood glucose in adults with the condition.
- Shire launched pediatric indication for immunodeficiency treatment HyQvia in Europe
According to the announcement published on Shire’s website, this follows the recent marketing authorization granted by the European Commission to Baxalta, now part of Shire, in June 2016.
- Spark Therapeutics and Pfizer announced receipt of FDA breakthrough therapy designation for SPK-9001 for the treatment of hemophilia B
Hemophilia is a rare genetic bleeding disorder that causes the blood to take a long time to clot as a result of a deficiency in one of several blood clotting factors, and occurs almost exclusively in males.
- Health Minister: 12 European countries will establish an agreement to negotiate with the pharmaceutical sector
As stated by Health Minister Vlad Voiculescu in a recent press release, 12 countries in Central and Eastern Europe will establish an agreement that will have a stronger negotiating position with the pharmaceutical sector for access to medicines.
- EFPIA's statement on Brexit was recently published on its website
As everyone involved in European healthcare considers the implications of the UK referendum result, the European Federation of Pharmaceutical Industries and Associations (EFPIA) underscores the importance of ensuring that the patient is at the centre of all subsequent decisions.
- IGBA joins ICH and welcomes the positive vote of the General Assembly
The International Generic and Biosimilar Medicines Association (IGBA) welcomed decision of the ICH General Assembly to accept the IGBA as an Assembly Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
- EC: Targeted stakeholder consultation on the draft Guidelines on Good Manufacturing Practice for advanced Therapy Medicinal Products
As reported in a press release published by the European Commission (EC) on its website, the targeted stakeholders are small and medium-sized enterprises (SMEs) and academia involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products (“ATMPs”).
- EMA: Statement on the outcome of the UK referendum
According to the statement posted on its website, procedures and work streams of the European Medicines Agency (EMA) continue as usual.
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