FDA accepts Biologics License Application for RSV vaccine
The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
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The Biologics License Application for nirsevimab as the first protective option against RSV for all infants has been accepted by the the US Food and Drug Administration (FDA).
Here, Sanofi’s Arnaud Robert and Brendan O’Callaghan explore how advances in digital technology, partnerships and new ways of working are supporting manufacture and delivery of medicines for patients across the globe.
Innate Pharma will receive a €25m upfront payment from Sanofi to license its B7H3 ANKETTM platform, which is creating a new class of molecules to induce synthetic cancer immunity.
Dupixent®, the first and only targeted medicine for prurigo nodularis has been approved by the EC for adults with a moderate-to-severe form of the condition.
The top 20 biopharma companies averaged a market capitalisation decline of $3.45 trillion in Q2 to $3.14 trillion in Q3 2022, says GlobalData.
Acoziborole showed significant success in clinical studies, suggesting it could simplify treatment and help eradicate sleeping sickness.
The European Commission has approved Enjaymo®, the first-and-only approved therapeutic for haemolytic anaemia in adults with cold agglutinin disease.
In a global first, the health sector has converged to incentivise supply chains and clinical trials to reduce emissions through the Sustainable Markets Initiative Health Systems Task Force.
NIIMBL and BioPhorum reveal open-access design models for a new buffer stock blending system that could help reduce bottlenecks in biomanufacturing plants.
Sanofi’s Japan-based manufacturing site near Tokyo will be sold to a European contract development and manufacturing organisation.
Results from several haemophilia trials have been presented at the International Society on Thrombosis and Haemostasis (ISTH) Annual Congress 2022, here EPR summarises some of the key developments.
Phase III trial data shows Dupixent® (dupilumab) has the potential to improve signs of eosinophilic oesophagitis (EoE) and support healthy weight gain in children with the condition.
Sanofi Global Health — a nonprofit unit of Sanofi set up in 2021 — has launched Impact®, a new brand of standard of care medicines dedicated for nonprofit distribution in 40 of the world’s lower-income countries.
The new Guide from ISPE presents best practices for design, operation, maintenance and quality of membrane-based water for injection (WFI) systems.
The pandemic has been a game-changer for the pharmaceutical industry, sending the seemingly inexorable globalisation trends into reverse, with Big Pharma increasingly seeking more domestic supply chain options. Here, Karen Winterhalter of Onyx Health shares her expert insights on the impact of this emerging trend on the industry.