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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Committee for Medicinal Products for Human Use (CHMP)
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CHMP recommends fifteen therapeutics at latest meeting
The EMA’s human medicines committee (CHMP) recommended fifteen medicines for various approvals at its January 2020 meeting; with ten drugs receiving marketing authorisation recommendations and five receiving positive opinions for specific treatments.
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EC approves ustekinumab to treat plaque psoriasis in patients age six to 11
The European Commission has granted marketing authorisation to Stelara (ustekinumab) to treat patients aged six to 11 with moderate to severe plaque psoriasis.
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EMA recommends five drugs for approval after December meeting
The EMA’s CHMP has adopted a positive opinion for five medicines and recommended extending the indications for eight more.
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EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
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EMA CHMP recommends seven medicines for approval
The EMA has suggested seven treatments to be granted marketing authorisations and also advocated indication extension for eight drugs.
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Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
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Imbruvica® granted expanded use from European Commission
The European Commission has approved the drug for two indications: chronic lymphocytic leukaemia and Waldenström's macroglobulinemia.
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EMA recommends Vitrakvi for EU marketing authorisation
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
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EMA releases medicinal approval recommendations
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
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EMA recommends authorisation to Amglidia for neonatal diabetes
Amglidia is a new formulation of glibenclamide, specifically developed for use in newborns, toddlers and children...
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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...
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Novartis receives EU approval for ribociclib
Novartis announced that the European Commission approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with metastatic breast cancer
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Sanofi and Regeneron receive CHMP positive opinion for rheumatoid arthritis treatment
28 April 2017 | By Niamh Marriott, Junior Editor
The European Medicine Agency's CHMP has adopted a positive opinion for the marketing authorisation of Sanofi and Regeneron Pharmaceuticals’ Kevzara...
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BioMarin receives positive CHMP opinion for fatal brain disorder treatment in children
26 April 2017 | By Niamh Marriott, Junior Editor
CHMP has adopted a positive opinion for the company's MAA for Brineura to treat children with Neuronal Ceroid Lipofuscinosis Type 2 disease...
