FDA and EMA team up to expedite complex generic drug development
This initiative builds on the original parallel scientific advice programme launched by the FDA and and the EMA in 2021.
09 February 2024
09 February 2024
This initiative builds on the original parallel scientific advice programme launched by the FDA and and the EMA in 2021.
Despite a $3.73m decline in the sales of Covid-19 medicines, the company's total revenue for 2023 grew by 6%.
The submission is based on data from the Phase III MARIPOSA clinical trial.
The companies will utilise translational medicine approaches to expedite the development of first-in-class medicines.
BioNTech will acquire Autolus’ American depositary shares for $200m in a private placement.
The survey by CRO Worldwide Clinical Trials shows that pharma and biotechs favour midsize contract research organisations (CROs) due to the personalised service.
Kowa will pay €3m upfront and up to €27.5m in milestone-based payment to gain rights for Nicox’s intraocular pressure (IOP) reduction drug in Japan.
AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards a biologics licence application (BLA) from the US Food and Drug Administration (FDA).
Merging industry-leading business intelligence & award-winning journalism, this is an unrivalled opportunity for engagement with B2B professionals across a network of 40+ leading media websites.
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