Clinical research
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.
The company said Thursday it has closed $200 million in Series B financing—on top of last year’s $200 million Series A haul—to help initiate a registrational Phase II study for its lead candidate UPB-101.
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.
Non-alcoholic steatohepatitis patients treated with the company’s efruxifermin saw significant improvements in liver fat and biomarkers of liver damage, fibrosis and cardiometabolic health.
Data from a new head-to-head study showed BMS’ Opdivo induced better progression-free survival among Hodgkin’s lymphoma patients than Seagen’s Adcetris.
After five years of follow-up, AstraZeneca’s Tagrisso reduces the risk of death by 51% as compared with placebo in EGFR-mutated NSCLC patients, according to Phase III ADAURA trial results.
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