Spotlight
CymaBay maps out regulatory filing for primary biliary cholangitis drug seladelpar
Regulatory applications in EU and the UK will follow a potential filing in the US in early 2024.
Latest news
Glenmark Pharma to divest 75% stake in life sciences unit for $680m
Following the divestiture, Glenmark Pharma will own a 7.84% stake in GLS.
FDA accepts Takeda's NDA resubmission for eosinophilic esophagitis therapy
The company is expecting a decision from the regulator in the first half of next year.
Evaxion partners with Afrigen Biologics to develop mRNA gonorrhea vaccine
The collaboration will use Evaxion’s EDEN platform to bring AI-designed mRNA vaccine to the market.
Yale and Transcend wins US DoD grant for PTSD therapy
The Department of Defense grant is to study methylone for the rapid and long-lasting treatment of PTSD.
Medicenna to expand Phase III glioblastoma trial globally
Medicenna is also starting to enrol patients in an ongoing Phase I/II trial in solid tumours investigating dose expansion of MDNA11.
Kezar and Everest enter lupus nephritis therapy development deal
Kezar is eligible to receive up to $132.5m in initial upfront and milestone payments.
Gilgamesh completes SAD and MAD studies of MDD therapy
The company plans to commence a Phase IIa study in MDD patients in the second half of this year.
In our previous edition
Pharma Decoded
ARS hits roadblock for neffy approval as FDA requests additional study
21 Sep 2023
Pharma Decoded
Otsuka and Astex's oral Inaqovi wins European approval for AML
20 Sep 2023
Pharma Decoded
FDA revises biosimilar guidelines for clearer drug labelling
19 Sep 2023
Still looking?
Search companies, themes, reports, as well as actionable data & insights spanning 22 global industries
Explorer
Access more premium companies when you subscribe to Explorer
Get in touch about GlobalData Company reports
Contact the team or request a demo to find out how our data can drive your business forward