This page shows the latest Committee for Medicinal Products for Human Use news and features for those working in and with pharma, biotech and healthcare.
In November 2021, Sanofi announced that as part of the European Medicines Agency’s (EMA) review of Nexviadyme, the Committee for Medicinal Products for Human Use (CHMP) issued an opinion that ... The Committee for Orphan Medicinal Product (COMP) also
The treatment for AADC will be the first marketed gene therapy to be administered directly into the brain. ... The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion for PTC
The EMA based its decision on a review conducted by the Committee for Medicinal Products for Human Use (CHMP), which showed an increased immune response after a third-dose booster with ... This technology has been used by scientists for the past 40 years
Kymriah is the first CAR-T cell therapy of its kind approved in the EU for follicular lymphoma. ... The EC’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) issued in March, making Kymriah the first CAR
Following regulatory blocks and rejections late last year, Biogen has decided to withdraw its application for its Alzheimer's drug Aduhelm (aducanumab) in Europe. ... The company made the decision to pull its application after discussions with the
The Committee for Medicinal Products for Human Use (CHMP) branch of the European Medicines Agency based its positive opinion on an evaluation of Evusheld data, which included results from the PROVENT ... Evusheld is authorised for emergency use for
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Most members of the EMA’s Committee for Medicinal Products for Human Use supported approval on the strength of the analysis but there was some pushback. ... Recognising that, the United Kingdom has sought to position its relatively standardised, single
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 ... So far, 37 sessions of
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 ... A promotional claim is not allowed
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The European Medicines Agency (EMA) has appointed France's Dr Pierre Demolis as vice-chair of the Committee for Medicinal Products for Human Use (CHMP). ... In his new role, he will work with chair Dr Tomas Salmonson of Sweden to head the CHMP, which
On their election, Mentzer and van den Berg thanked outgoing chair Daniel Brasseur, who has left the PDCO to become a member of the European Medicines Agency's Committee for Medicinal ... Products for Human Use (CHMP).
Its objective is to assess and monitor safety issues for human medicines, giving recommendations for consideration by the Committee for Medicinal Products for Human Use (CHMP). ... Its current chair is Dr June Raine of the UK's Medicines and Healthcare
Will serve a three-year term on EMA's scientific advisory committee. The EMA's Committee for Medicinal Products for Human Use (CHMP) has elected Dr Ian Hudson to serve as ... Dr Hudson has been a member of the scientific advisory committee since 2004 and
He replaces Eric Abadie who retired in April. Tomas Salmonson has been appointed chair of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). ... EMA's Committee for Proprietary Medicinal Products (CPMP) from 1999
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