A survey of British voters ahead of Thursday’s general election has revealed just how much importance they attach to the issue of access to medicines. 3 July 2024
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD). 3 July 2024
The UK Bioindustry Association (BIA) has joined the European Biosolutions Coalition, an initiative established by several industry organisations to elevate the prominence of biosolutions on Europe’s agenda. 2 July 2024
In the USA, two New Drug Applications (NDA) for crinecerfont have been accepted by the US regulator, and will be considered under the Priority Review scheme. 1 July 2024
pharma.be, the umbrella organization of innovative biopharma companies active in Belgium, has highlighted the publication of the Transparency Register 2023. 1 July 2024
Specialty vaccine company Valneva has announced that the European Commission (EC) has granted marketing authorization for its single-dose vaccine, Ixchig, for the prevention of disease caused by the chikungunya virus in people aged 18 years of and older. 1 July 2024
AstraZeneca’s Marketing Authorization Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 1 July 2024
Latin American countries have taken on the task of exploring how a tool such as regulatory reliance can be better used to improve health ecosystems in the region, based on trust and teamwork, without having to complete their own thorough reviews that demand time and resources. 1 July 2024
Johnson & Johnson (NYSE: JNJ) has received a new European approval for a combination of Rybrevant (amivantamab) plus chemotherapy in lung cancer. 28 June 2024