News | July 22, 2023
Merck receives positive European Union CHMP opinion for Gefapixant
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union
Mage Biologics to develop a monoclonal antibody targeting ulcerative colitis
The Long-term Safety Trial was approved to be conducted by China National Medical Products Administration (NMPA) on 18 April 2023
Approval to dramatically change CAR-T therapies landscape
SMPA's diverse portfolio includes six marketed products and a robust pipeline of early- to late-stage assets
Rare childhood cancer subtype, Ph+ ALL, is found in 3-4% of pediatric cases and 25% of adult cases
The positive safety review from the DSMB enables the trial to move forward as planned, with an estimated completion date in December 2023
As Caeregen’s CDMO partner for CTR-107, Wacker Biotech will produce drug substance at its site in Halle, Germany, and complete clinical trial drug product production at its site in Amsterdam, the Netherlands
Under the terms of the collaboration, Vertex and Lonza will partner in the process development and scale-up for the manufacturing of the product portfolio and co-invest to build a dedicated new facility in Portsmouth, New Hampshire (US)
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
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