UPDATE: AZ/Oxford University COVID-19 vaccine gets EU approval

CMA) for use in people aged 18 years and older. ... The European Medicines Agency (EMA) recommended the CMA on Friday, following an assessment conducted by its Committee for Medicinal Products for Human Use (CHMP) of all the available safety and efficacy

Novartis gains EU approval for relapsing MS drug Kesimpta

The approval came after a positive opinion was issued for subcutaneous Kesimpta (ofatumumab) in RMS by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in January ... Roche’s drug is also the only drug approved

EMA recommends new manufacturing sites for COVID-19 vaccines

EMA also recommends new storage temperature for Pfizer/BioNTech vaccine. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended new manufacturing capacity and supply ... The CHMP has also recommended

J&J’s multiple sclerosis therapy Ponvory moves closer to EU approval

Johnson &Johnson's (J&J) multiple sclerosis (MS) therapy Ponvory has moved closer to approval in the EU, after receiving a positive recommendation from the European Medicines Agency’s (EMA) Committee ... for Medicinal Products for Human Use (CHMP) today

Roche, Regeneron’s COVID-19 antibody cocktail cuts hospitalisation or death by 70%

Following this, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a scientific opinion (under Article 5(3) of Regulation 726/2004) supporting the use of casirivimab and ... In the US, the FDA has granted Roche and Regeneron’s

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