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CHMP
This page shows the latest CHMP news and features for those working in and with pharma, biotech and healthcare.
Sanofi’s rare blood disorder drug Cablivi set for European approval
Among the other recommendations, Ultragenyx picked up a positive CHMP opinion for its mucopolysaccharidosis type VII drug – Mepsevii (vestronidase alfa) – which was approved in the US last November. ... The drug should be used as when standard
Latest news
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CAR-Ts Kymriah and Yescarta step closer to approval in Europe
The CHMP says it recommends adding this uses to its licensed indications, as it is would otherwise have to be used off-label, and is also obliging Novartis and Gilead to ... Reimbursement and new cell therapy infrastructure. The CHMP opinions will
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Daily Brief: Europe reverses stance on Puma’s neratinib, Pfizer expands healthcare hubs, AbbVie and Calico boosts age-related diseases collab
The EMA's Committee for Medicinal Products for Human Use (CHMP) is set to approve the use of Puma Biotechnology’s neratinib for the extended adjuvant treatment of early stage HER2
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Daily Brief: ASCO latest, Europe cautions on immunotherapy, rejects Duchenne treatment
CHMP approvals round-up. Friday also saw the CHMP release its recommendations on the latest crop of novel medicines, biosimilars and generics. ... schizophrenia. The CHMP also recommended Sandoz’s biosimilar of AbbVie’s blockbuster inflammation
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PMCPA takes AZ to task over asthma drug press release
Products for Human Use (CHMP) last November, which it claimed contained “unbalanced and misleading”statements on Fasenra’s clinical data and was effectively an advert for the drug.
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Daily Brief: Trump's America First speech, Is Europe's PRIME speeding up drug approvals?
One of the key benefits of the scheme is the PRIME kick-off - a multidisciplinary meeting with the CHMP/CAT Rapporteur, their assessment team and a multidisciplinary group of experts from
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Approximately 107 fully matching, plus 310 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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