European Medicines Agency’s (EMA)

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Developments in stability testing and evaluation

4 September 2019 | By David Elder (JPAG Chair), Dr Conor Jamieson (Sandwell and West Birmingham NHS Trust), Dr Gary Scrivens (Pfizer), Dr Jonathan Bright (AstraZeneca), Dr Maria Krisch (FreeThink Technologies), Dr Paul Fullerton (AMRI), John Cleverley (Clarivate Analytics), Rachel Orr (GlaxoSmithKline), Susan Smith (AstraZeneca)

The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.

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EMA recommends marketing authorisation to Tegsedi for hereditary transthyretin amyloidosis

7 June 2018 | By European Pharmaceutical Review

The EMA has recommended granting a marketing authorisation for Tegsedi, a medicine for the treatment of stage 1 or stage 2 polyneuropathy...

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Enzyme replacement therapy to treat alpha-mannosidosis

29 January 2018 | By Dr Zara Kassam (European Pharmaceutical Review)

The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...