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CHMP meeting highlights – March 2023
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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European Medicines Agency’s (EMA)
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EMA human medicines committee (CHMP) highlights, November 2022
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
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
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
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
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
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
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
The EMA has recommended granting a marketing authorisation in the EU for Lamzede a long-term enzyme replacement therapy for alpha-mannosidosis...
