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CHMP
This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
Alnylam gets EU nod for Onpattro amid pricing backlash
The EU approval follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP), and is based on the APOLLO study, in which patients given an
Latest news
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ICER says Alnylam’s Onpattro should cost 90%-95% less
for Medicinal Products for Human Use (CHMP) last month.
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Alnylam claims first RNAi approval from FDA for patisiran
Europe after getting a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) last month.
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Daily Brief: Cellectis gains Novartis scientist, EU label updates for Janssen and Otsuka
The CHMP’s positive opinion will now be reviewed by the European Commission, which has the authority to grant approval of the updated label. ... The CHMP decision is based on the results of the CANVAS programme, the largest completed CV outcomes trial
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First migraine prevention drug to hit European market
The European Commission (EC) approved the novel treatment yesterday after it received a positive recommendation from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) last
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CHMP turns down BMS’ Opdivo/Yervoy for kidney cancer
CHMP turns down BMS’ Opdivo/Yervoy for kidney cancer. The committee also turned down Amgen’s Blincyto, Portola’s Dexxience and Radius International’s Eladynos. ... quarter – making $1.67bn and $1.65bn respectively – and the CHMP rubbed salt
More from news
Approximately 110 fully matching, plus 316 partially matching documents found.
Latest Intelligence
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The European Medicines Agency: PRIME’d for access?
Early signs are looking good: Novartis’Kymriah (tisagenlecleucel) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel) secured positive opinions from EMA's Committee for Medicinal Products for Human Use (CHMP) in June
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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
More from intelligence
Approximately 0 fully matching, plus 9 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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