Unusual national coverage determination for a prevention-only drug was opened in response to a formal request from ViiV for its long-acting injectable.  

The European Medicines Agency’s latest list of drugs under review for potential marketing approval includes a second generalized myasthenia gravis treatment from UCB and what could become the first biosimilar version of Stelara in the EU.

Japan's top pharma firms logged generally strong performances for mainstay global drugs in the fiscal period ended 30 September, with the weakened yen adding substantially to figures for those with large overseas sales. Astellas and Eisai are among those awaiting important global-first approvals for potential blockbusters.

Shionogi unveiled its latest pipeline update, including a focus on long-standing key areas such as HIV and COVID-19 and a new obesity candidate, at its recent R&D Day, amid struggles to line up new products for launch over the next few years. The Japanese firm also seems set to seek further in-licencing collaborations.