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The designation covers adults with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutant, hormone receptor positive, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression after treatment with

Samsung Biologics is set to become part of CEPI’s Vaccine Manufacturing Facility Network (VMFN), aiming to speed up the availability of protein-based vaccines and improve access during outbreaks

The deal grants Genentech exclusive global rights to develop and commercialise the selected RNAi programme. According to the contract, SanegeneBio will manage early development activities while Genentech will

The therapy aims to treat Type I allergic reactions, including anaphylaxis, in patients weighing 30kg or more. The CRL highlights deficiencies in human factors validation for Anaphylm, such

The CHMP recommends the use of niraparib and abiraterone acetate with prednisone or prednisolone (AAP), along with androgen deprivation therapy (ADT), specifically for patients with metastatic hormone-sensitive prostate

The initiative aims to speed up the development of platform-based genetic therapies for rare diseases in the US. It also aims to create a scalable model to deliver

As part of this agreement, Boehringer Ingelheim will utilise IQVIA’s data-as-a-service (DaaS+) technology to advance its global commercial data transformation, aiming to streamline data management and analytics across

The partnership will focus on creating treatments intended to restore immune homeostasis and deliver durable remission for patients, avoiding the generalised immune suppression associated with existing therapies. Under

The financing includes a €20m strategic investment from Sanofi and €40m from existing and new investors such as Artal (advised by Invus), Redmile Group, Cormorant Asset Management, Sofinnova