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
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Planned investment of approximately USD 90 million to build a state-of-the-art Sandoz Biosimilar Technical Development Center in Ljubljana, Slovenia by 2026
Deal includes DTx-1252, a potential therapy for the neuromuscular disorder Charcot-Marie-Tooth disease type 1A (CMT1A), and two additional preclinical programs for other neuroscience indications
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU
PrecisionLife to analyse OXEGENE data to improve mechanistic understanding of endometriosis and identify novel drug targets to support the development of new personalised treatments
The €70 million investment will allow the large-scale manufacturing of high-purity reagents for quality control and testing for biopharma customers, increasing annual output by several thousand tons
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
Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.
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