Phase III
Following cases of serious bleeding in patients, five of which were fatal, the regulator has put Mersana’s investigational antibody-drug conjugate UpRi on partial clinical hold in two ovarian cancer trials.
Valneva’s chikungunya vaccine candidate VLA1553 showed that the shot safely and rapidly induced high rates of seroprotection. Merck earlier in 2023 discontinued its chikungunya program.
The company is paying $3.2 billion upfront in cash for Chinook’s two immunoglobulin A nephropathy candidates, atrasentan and zigakibart, which will complement its own IgAN hopeful iptacopan.
Data show the potential of Editas’ sickle cell disease and transfusion-dependent beta thalassemia gene therapy candidate, but it might not be enough to overtake Vertex and CRISPR Therapeutics.
The FDA has launched a new super office to prepare for myriad decisions on cell and gene therapies, including the potential first CRISPR therapy and the first gene therapy for Duchenne muscular dystrophy.
In a 6-0 vote, the FDA’s advisory committee Friday affirmed that trial data confirmed the clinical benefit of Eisai and Biogen’s Leqembi (lecanemab) for the treatment of Alzheimer’s disease.
In a late-stage study of non-ambulatory patients with DMD on background corticosteroids, pamrevlumab failed to meet the primary endpoint for upper limb performance.
While approved in non-small cell lung cancer, Keytruda failed to provide benefit for the TKI-resistant, EGFR-mutant subtype of the disease.
Biogen, and partner Denali, are discontinuing the Phase III LIGHTHOUSE study of BIIB122 in Parkinson’s disease due to the trial’s long timeline and complexity.
The combination therapy was added to standard chemotherapy and lowered the risk of progression or death by 37% in newly diagnosed patients with advanced ovarian cancer without BRCA mutations.
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