Following the pre-NDA meeting with the U.S. FDA, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPD
The quarter also saw continued investment in new technologies and the successful implementation of several digitization and automation projects across operations
First anticipated spinout from the alliance, Circle Therapeutics, to develop novel muscle stem cell therapies for a variety of skeletal muscle disorders
This expansion will support the global operations network and help meet global demand for mammalian development services that support Lonza’s manufacturing sites
VIPER AI solutions support care teams by automating the identification of potentially eligible patients at the time of diagnosis and easily matching them to relevant trials
It becomes the first ophthalmology biosimilar to gain FDA approval in the United States
BB will have access to 100 million doses of vaccines annually and commercialization rights of the SILS vaccine portfolio for global markets
HTL will build, validate and operate a botulinum manufacturing facility in the US
Sandoz is committed to building on its leading generic and biosimilar oncology portfolio to further expand patient access while contributing to the sustainability of healthcare systems
The global CRAMS segment is expected to clock 6.2% CAGR over CY21-26E to touch US $ 170 billion
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