Europe

As efforts to improve diversity in clinical trials gain momentum globally, regulators in the UK, the EU, Canada, Australia and Japan were asked about their efforts to support representative enrolment. 

Teva has announced two major biosimilars deals in quick succession, partnering with Samsung Bioepis on its US Epysqli eculizumab rival to Soliris and Formycon on its European Ahzantive aflibercept challenger to Eylea.

Stada has made the strongest indication yet that it is preparing for an initial public offering, appointing Andreas Fibig as independent chairman of a board of directors that will be established “in the event of an IPO.”

Stada has made the strongest indication yet that it is preparing for an initial public offering, appointing Andreas Fibig as independent chairman of a board of directors that will be established “in the event of an IPO.”

Alexion has been refused in its bid for injunctions to block the sale of Samsung Bioepis and Amgen’s European Soliris biosimilars, following a decision by the Court of Appeal of Europe’s Unified Patent Court.

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include Alhemo, Novo Nordisk's product for the prevention of bleeding in patients with hemophilia A and FVIII inhibitors or hemophilia B and FIX inhibitors.

France’s medtech sector is strong, growing and innovative. In Vivo spoke to several French medtech leaders about the unique features and pitfalls their industry may face.