This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
The European approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) last December, which gave its recommendation based on results from ADMIRE-CD,
ViiV’ s two-drug HIV combo backed by CHMP. The committee also backs two biosimilar medicines. ... ViiV Healthcare’s dual HIV therapy Juluca has been given a green light by the EMA’s Committee for Medicinal Products for Human Use (CHMP), setting up
for Medicinal Products for Human Use (CHMP).
The biosimilar was granted marketing authorisation last month following a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for HER-2-positive
CHMP backs AZ’ s Lynparza for ovarian cancer maintenance. Studies show that the drug reduced risk of disease progression. ... The CHMP has backed the new easier-to-take tablet formulation of Lynparza (olaparib) for use as maintenance therapy in women
Pfizer’ s leukaemia drug Mylotarg backed for use in EU. The CHMP’s positive opinion could see the drug return to market after almost eight years. ... Pfizer’s Mylotarg looks set to return to the EU market after a gap of several years, with the CHMP
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Approximately 105 fully matching, plus 302 partially matching documents found.
In December 2017, the CHMP of the EMA gave a positive opinion recommending a marketing authorisation for Cx601, so it was probably a good time for Takeda to make a move.
Healthcare terms - Drug safety.
Healthcare terms - Drug R&D.
In the US, five biosimilars were approved in 2016. In the EU, eight new approvals for biosimilars were recommended for approval by the CHMP in 2016; four of these were still
After long discussions between politicians in the respective countries about its safety, and after the CHMP's (EMA Committee for Medicinal Products for Human Use) recommendation, the European Commission finally made
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Approximately 0 fully matching, plus 8 partially matching documents found.
Commissioners also frequently attend the European Committee on Human Medicinal Products (CHMP) meetings as part of the UK delegation.
international agencies – FDA, EMA/CHMP, Health Canada, and PMDA – at multiple levels will be critical to Kite's further advancement and planning.”.
CHMP names France's Pierre Demolis vice-chair. He is director of the oncology and haematology division at the ANSM. ... Dr Demolis' appointment comes after six years serving as a member of the CHMP.
Products for Human Use (CHMP).
Hudson is also the UK delegate and vice chairman of the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency.
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Approximately 3 fully matching, plus 5 partially matching documents found.
In addition, Wordbird has provided consultancy in responding to CHMP questions during the reclassification process.
Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.
Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.
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Approximately 0 fully matching, plus 3 partially matching documents found.
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