Europe – EMA addresses use of registry-based studies

The European Medicines Agency (EMA) has issued a new guideline on registry-based studies, giving detailed advice for use of patient registries in both the...

Europe – How incidents with medicines are managed in the EU – a ten-year...

The EU medicines network is supported by a robust regulatory framework with defined processes and clear responsibilities in place to handle public health incidents,...
What Happens to SPCs and Patents After the Brexit Transition Period

UK – Brexit Readiness Checklist for companies doing business with the UK

The United Kingdom’s choice to cease to participate in the EU’s Single Market and Customs Union and put an end to the free movement...
WHO drafts guidance for pharma supply chain tracking

International – WHO: Two-thirds of global population now participating in COVAX initiative

Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator....

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

Seven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting. The CHMP adopted a positive opinion for Exparel (bupivacaine),...

Europe – New oral treatment for moderate to severe atopic dermatitis

EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are...

Europe – New treatment for children with chronic kidney disease

EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with...

UK – BMS’ Opdivo wins new NICE lung cancer backing

First-line of treatment for locally advanced stages of the disease is currently either chemotherapy or a PD-1 or PD-L1 inhibitor; Opdivo has been endorsed...
Ibrance given NICE green light in breast cancer

UK – NICE u-turn sees Akcea’s Waylivra win NHS funding

FCS is the name for a group of rare genetic disorders that affect between 55 and 110 people in England. The condition results in...

Europe – Convergence: EMA close to finalizing guidance for advanced therapies

The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric...

NOS PROCHAINES FORMATIONS