Final NICE guidance issued for Akcea’s Tegsedi

UK – Final NICE guidance issued for Akcea’s Tegsedi

The Highly Specialised Technologies (HST) Guidance is for the treatment of stage I or II polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR). It...
UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a...
Exporting active substance manufactured in the UK in a no deal scenario

UK – Exporting active substance manufactured in the UK in a no deal scenario

Leaving the EU with a deal remains the Government’s top priority. This has not changed. However a responsible government must plan for every eventuality,...
After discount row, NICE finally says yes to first line Revlimid

UK – After discount row, NICE finally says yes to first line Revlimid

While Revlimid has become the ‘backbone treatment’ for multiple myeloma patients in most developed countries, it has been used only as a third line...
After discount row, NICE finally says yes to first line Revlimid

UK – NICE recommends Sprinraza for 5q spinal muscular atrophy

The recommendation is for infants, children and adults with 5q spinal muscular atrophy and will be available through a scheme known as a Managed...
Brexit "having impact on EU drug development”

Europe – Brexit « having impact on EU drug development”

The sacrifices made by the agency in 2018 as a result of the UK’s planned withdrawal from the EU have already hit activities such...
EMA annual report 2018 published

Europe – EMA annual report 2018 published

The annual report published today provides an overview of the Agency’s activities to protect and promote the health of people and animals in the EU and...
EMA : Working together for safe medicines in the EU

Europe – EMA : Working together for safe medicines in the EU

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective. As of today, EMA will...
Sartans Article 31 referral - CHMP assessment report

Europe – Sartans Article 31 referral – CHMP assessment report

1. Information on the procedure The EU authorities were notified on June 2018 that an Active Pharmaceutical Ingredient (API) manufacturer (Zhejiang Huahai Pharmaceutical, China) has...
After discount row, NICE finally says yes to first line Revlimid

UK – NICE recommends Roche’s Tecentriq for metastatic NSCLC

The recommendation is for use of the drug in combination with Avastin (bevacizumab), carboplatin and paclitaxel for patients who have not had treatment for...

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