Europe – New treatment against Duchenne muscular dystrophy
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Duvyzat (givinostat) as a treatment for Duchenne muscular dystrophy (DMD) in patients...
UK – MHRA approves first UK treatment for Friedreich’s ataxia, omaveloxolone
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 23 April, approved omaveloxolone (Skyclarys), the first treatment for patients aged 16 and over,...
Europe – First treatment against severe thyroid eye disease
EMA has recommended granting a marketing authorisation in the European Union (EU) for Tepezza (teprotumumab), for the treatment of adults with moderate to severe thyroid eye...
UK – AstraZeneca’s Truqap recommended by NICE to treat advanced breast cancer
The health technology assessment agency has recommended in final draft guidance that the drug be used in combination with AZ’s endocrine therapy Faslodex (fulvestrant)...
Europe – Revised general chapters for elemental analysis published in Pharmeuropa 37.2
Analytical procedures for elemental analysis are described in the following European Pharmacopoeia (Ph. Eur.) general chapters:
2.2.22. Atomic emission spectrometry;
2.2.23. Atomic absorption spectrometry;
...
UK – First treatment for common bladder cancer recommended by NICE
Balversa (erdafitinib) has been recommended for use on the NHS as the first and only treatment in the UK for urothelial cancer (UC) involving...
Europe – European Parliament adopts pharmaceutical reform package
The European Parliament has voted to adopt a pharmaceutical reform package that includes new legislation and regulations in the first major overhaul of the...
Europe – European Commission approves ustekinumab for paediatric Crohn’s disease
The European Commission (EC) has approved ustekinumab for the treatment of moderately to severely active Crohn’s disease in paediatric patients weighing at least 40...
UK – Eplontersen approved to treat adults with rare inherited nerve disease or polyneuropathy
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved eplontersen (Wainzua) to treat adults with polyneuropathy associated with hereditary transthyretin amyloidosis (ATTRv), which...
Europe – EPC adopts groundbreaking chapter on cell-based preparations for human use
After several years of work by the Cell Therapy Products Working Party (CTP WP), the European Pharmacopoeia Commission (EPC) adopted the new general chapter Cell-based...
