Phase III
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
An experimental AstraZeneca drug for Wilson disease hit the mark in a Phase III study in which the drug, ALXN1840, was able to mobilize copper three times greater than standard-of-care.
PhaseBio is working toward mitigating the surgical risks for cardiac patients taking antiplatelet therapies with bentracimab, which is currently in Phase III development.
AbbVie filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for Qulipta for the preventative treatment of migraine.
Athira Pharma is putting a positive spin on its topline data from a Phase II trial of fosgonimeton, emphasizing positive subgroup analysis, but it missed the primary endpoint.
TC BioPharm is developing a new approach to chimeric antibody receptor (CAR) T-cell therapies with the potential to eliminate off-target effects, and possibly help more patients.
9 Meters Biopharma is discontinuing a Phase III clinical trial for larazotide, a treatment for celiac disease as interim results were not statistically significant.
The week began with positive updates in the vaccine development space against various infectious diseases from Emergent, Merck, Affinivax and Ocugen.
AstraZeneca and Ionis reported that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy hit its co-primary endpoints.
In the coming 12 months, Rain expects to have an interim readout for a Phase II study of its liposarcoma therapy, milademetan, and a pivotal readout for its Phase III trial of the same compound.
PRESS RELEASES