Sage will initiate three new trials to support FDA approval of the drug for post-partum depression and major depressive disorder, with data anticipated in 2021.
Sage Therapeutics Inc. has a revised plan for bringing zuranolone (SAGE-217) to market in major depressive disorder and post-partum depression, but it will mean pushing out the launch likely until 2022. The company updated investors on the timeline on 18 March, based on input from the US Food and Drug Administration.
The company is initiating three new trials, all exploring a higher 50mg dose of zuranolone versus the 30mg dose that...
GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results
Amgen’s Imdelltra for small-cell lung cancer is one of two bispecific T-cell engagers approved for solid tumors, but data at the WCLC meeting show other DLL3-targeting BiTEs may be on the way.
An academic study of GLP-1 agonist showed promise in patients with the painful skin condition but with no signs that the Danish drugmaker will pursue the indication, smaller players in the space may be interested.
As it posts third-quarter numbers that again reveal the decline of revenues from its multiple sclerosis portfolio, the US biotech major is entering into the hot area of targeted protein degradation to boost its immunology and neurology pipeline.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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