Positive CHMP opinion issued for PTC Therapeutics’ Upstaza

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

AstraZeneca’s COVID-19 vaccine receives EMA approval for use as third-dose booster

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

EC approves Novartis’ Kymriah for advanced blood cancer

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

Biogen retracts EMA application for Alzheimer's drug Aduhelm

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

CHMP recommends marketing authorisation for AZ’s Evusheld in the EU

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

The evolution of real-world studies

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

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 ... So far, 37 sessions of

Drug safety

Drug R&D

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 ... A promotional claim is not allowed

CHMP names France's Pierre Demolis vice-chair

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

EMA’s Paediatric Committee elects new leaders

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).

EMA’s Pharmacovigilance Risk Assessment Committee gains new members

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

Dr Ian Hudson elected vice chair of CHMP

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

Sweden’s Tomas Salmonson to chair EMA’s CHMP

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