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ViiV’s Potential HIV Blockbuster Among Latest Drugs To Win EMA Nod

 
• By Neena Brizmohun

A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.

Virus
ViiV's Dovato could provide a new way of treating HIV in the EU • Source: Shutterstock

The European Medicines Agency has recommended that 13 drugs be approved for sale across the EU including ViiV Healthcare’s Dovato (dolutegravir/lamivudine), a single-pill, two-drug regimen for HIV, for which a blockbuster future has been forecast.

Ultomiris (ravulizumab), Alexion Pharmaceuticals’ follow-up to its blockbuster paroxysmal nocturnal hemoglobinuria treatment, Soliris (eculizumab), was also among the products...

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More from Europe

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

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New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

More from Geography

Swissmedic Appoints Trivigno As New Agency Head From 2026

 
• By Anabel Costa-Ferreira

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.