FDA grants ODD to Keros KER-065 for treatment of Duchenne muscular dystrophy
KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB
KER-065 is a novel ligand trap comprised of a modified ligand-binding domain derived from activin receptor type IIA and activin receptor type IIB
The accelerated approval is supported by results from part 1 of the ESSENCE trial
The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations
During the quarter, construction began on a US$ 10 million bioconjugation cGMP suite at NJ Bio’s Princeton site
NJ Bio is currently executing a major new program for an existing innovator customer with multiple ADC candidates in their pipeline
Athena is also exploring the use of this technology for expanded carrier screening
7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors
The scheme aims to avoid disruption in supply of critical active pharmaceutical ingredients (APIs) used to make critical drugs
Prof. Götz is Director of the Institute of Stem Cell Research at Helmholtz Center Munich and Chair of Physiological Genomics at Ludwig-Maximilians-Universität, Munich
This project builds on a previous joint funding agreement between CARBOGEN AMCIS and the same customer in April 2021
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