European Medicines Agency’s (EMA)

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CHMP meeting highlights – March 2023

3 April 2023 | By Catherine Eckford (European Pharmaceutical Review)

In the European Medicines Agency's March human medicines committee meeting, nine new medicines were recommended, including one for multiple sclerosis.

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EMA human medicines committee (CHMP) highlights, November 2022

14 November 2022 | By Catherine Eckford (European Pharmaceutical Review)

The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.

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EMA’s PRAC confirms recommendation to withdraw amfepramones

31 October 2022 | By Catherine Eckford (European Pharmaceutical Review)

The EMA’s safety board verifies that amfepramone-containing products for obesity should not be sold, due to higher-associated health risks.

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EMA validates AbbVie lymphoma bispecific antibody application

31 October 2022 | By Catherine Eckford (European Pharmaceutical Review)

AbbVie's marketing application for epcoritamab in adults with relapsed/refractory diffuse large B-cell lymphoma has been validated by the European Medicines Agency.

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Pilot to support ATMP research and development

4 October 2022 | By Catherine Eckford (European Pharmaceutical Review)

Five academic and non-profit organisations developing advanced therapy medicinal products (ATMPs) will benefit from the European Medicines Agency’s (EMA) scheme.

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Ronapreve^™ reduces COVID-19 viral load within seven days

30 September 2021 | By Anna Begley (European Pharmaceutical Review)

Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.

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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...