Gilead’s Veklury recommended by CHMP for COVID-19 in patients with hepatic impairment

Gilead Sciences has announced that its COVID-19 treatment Veklury (remdesivir) has been recommended by the European Medicines Agency’s human medicines committee for use in patients with mild-to-severe ... The Committee for Medicinal Products for Human

Almirall receives CHMP recommendation for lebrikizumab in atopic dermatitis

Almirall has announced that its IL-13 inhibitor lebrikizumab has been recommended by the European Medicines Agency’s human medicines committee to treat moderate-to-severe atopic dermatitis. ... The Committee for Medicinal Products for Human Use (CHMP)

Pfizer and BioNTech’s XBB.1.5-adapted COVID-19 vaccine recommended by CHMP

Pfizer and BioNTech’s Omicron XBB.1.5-adapted monovalent COVID-19 vaccine has been recommended by the European Medicines Agency’s human medicines committee for individuals aged six months and ... older. The Committee for Medicinal Products for Human

Roche’s spinal muscular atrophy therapy recommended by CHMP for newborns

Roche’s spinal muscular atrophy (SMA) therapy has been recommended by the European Medicines Agency’s human medicines committee for use in infants aged under two months. ... The Committee for Medicinal Products for Human Use (CHMP) has recommended

Janssen receives positive CHMP opinion for Talvey in multiple myeloma

Janssen, a Johnson &Johnson company, has announced that its bi-specific antibody, Talvey (talquetamab), has been recommended by the European Medicines Agency’s (EMA) human medicines committee for use in certain ... The Committee for Medicinal Products

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