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CHMP
This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy
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,
Latest news
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ViiV’s two-drug HIV combo backed by CHMP
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
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AZ finally gets EU nod for Veltassa rival Lokelma
for Medicinal Products for Human Use (CHMP).
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Mundipharma adds breast cancer biosimilar to its portfolio with Celltrion deal
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
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CHMP backs AZ’s Lynparza for ovarian cancer maintenance
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
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Pfizer’s leukaemia drug Mylotarg backed for use in EU
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.
Latest Intelligence
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Deal Watch January 2018
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.
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Drug safety
Healthcare terms - Drug safety.
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Drug R&D
Healthcare terms - Drug R&D.
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Europe vs the US: New drug product approvals
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
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The pill branding
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
More from intelligence
Approximately 0 fully matching, plus 8 partially matching documents found.
Latest appointments
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MHRA names vice-chair of Commission on Human Medicines
Commissioners also frequently attend the European Committee on Human Medicinal Products (CHMP) meetings as part of the UK delegation.
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Kite Pharma appoints head of regulatory affairs
international agencies – FDA, EMA/CHMP, Health Canada, and PMDA – at multiple levels will be critical to Kite's further advancement and planning.”.
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CHMP names France's Pierre Demolis vice-chair
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.
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EMA’s Paediatric Committee elects new leaders
Products for Human Use (CHMP).
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DH names new chief executive of the MHRA
Hudson is also the UK delegate and vice chairman of the Committee on Human Medicinal Products (CHMP) at the European Medicines Agency.
More from appointments
Approximately 3 fully matching, plus 5 partially matching documents found.
Latest from PMHub
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Wordbird helps ellaOne® fly over the counter
In addition, Wordbird has provided consultancy in responding to CHMP questions during the reclassification process.
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NDA
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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Research and development
Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.
More from PMHub
Approximately 0 fully matching, plus 3 partially matching documents found.
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- BenevolentAI raises $115m to fund drug development
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- Abeona Therapeutics names CEO
- Zelluna Immunotherapy appoints chief technology officer
- Spirit Health Group offers new market access consultancy service
- Why heading online for scientific meetings can yield greater HCP engagement
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Latest intelligence
- Why heading online for scientific meetings can yield greater HCP engagement
- Modern conferencing methods, with enhanced digital information transfers, offer unique opportunities for greater HCP engagement....
- The threat of antimicrobial resistance
- Why this issue is such a fundamental challenge...
- Meet the CEO behind ReNeuron’s cutting-edge stem cell therapies
- Blue Latitude Health speaks to Olav Hellebo, CEO of ReNeuron, to find out about the biotech’s latest innovation in stem cell therapy and to learn his perspective on navigating the...
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