European Commission grants AstraZeneca three new approvals

The EC’s decision, which follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP) in December, was supported by positive results from the HIMALAYA and POSEIDON phase ... Paolo Ghia, director, strategic research programme on

EC approves first gene therapy for adults with haemophilia B

Patients with moderate-to-severe haemophilia B typically require a routine treatment regimen of intravenous (IV) infusions of factor IX replacement products to maintain sufficient levels of clotting factor to prevent ... The EC’s decision, which

Safety-related change to label for Biogen’s Alzheimer's drug Aduhelm approved by FDA

that the use of antithrombotic or thrombolytic medications while taking Aduhelm may increase the risk of bleeding in the brain’. ... symptoms. Biogen withdrew its application for the use of Aduhelm in Europe in April 2022 after discussions with the

AstraZeneca’s heart failure treatment approved for expanded use in EU

AstraZeneca’s (AZ) Forixga (dapagliflozin) has been approved for extended use in the EU, with its indication now covering heart failure patients across the full spectrum of left ventricular ejection fraction ... The European Commission’s decision,

Sandoz’s biosimilar denosumab application accepted by FDA for osteoporosis

Sandoz, which has a total of eight marketed biosimilars and over 15 in various stages of development, received a recommendation from the European Medicines Agency’s Committee for Medicinal Products for ... Human Use (CHMP) last month for a citrate-free

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