The blockbuster GLP-1 analog demonstrated a capability for fibrosis reduction and disease resolution in the Phase III ESSENCE study. The firm plans to file for approval in 2025.
The changes expand the commercial potential of the PD-1/VEGF targeting immunotherapy's trial, but worries about delays and endpoint success have reigned in Summit's formerly skyrocketing share price.
The UK group began more clinical trials last year than any other company, a new report from Citeline has found.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The company presented positive Phase III data at the American Society of Nephrology meeting for the factor B inhibitor in C3G, a rare kidney disease with no approved treatments.
Although from a small Phase I/Ib study, Arcus presents data showing better response rate, disease control and tolerability for casdatifan compared to Merck’s approved renal cell carcinoma drug Welireg.
The gene-editing therapy produced functional cures in eight of 11 patients receiving the go-forward 50mg dose, but the rate fell short of what some investors had hoped for.
Senior executives from GSK, Bayer, Johnson & Johnson and Novartis discuss their experiences and some of the practical aspects of deploying AI in clinical trials. The potential of the technology to fundamentally alter how firms ensure the quality of data was also among the key talking points.
Pfizer beat GSK with a new indication for its RSV vaccine in high-risk individuals aged 18-59.
A Phase II failure with an old asset throws the company’s biomarker-driven strategy into doubt.
Positive data on its anti-TIGIT antibody belrestotug meant ITeos provided one of the biggest stories at ESMO this year. CEO Michel Detheux told Scrip there was much more to come from the US-headquartered biotech founded in Belgium.
The company announced positive interim results for sibeprenlimab, one of seven IgAN candidates in late-stage development from multiple manufacturers.
Two of 2030’s forecast blockbuster obesity drugs are facing binary readouts by the end of the year. Here’s what that could mean for their developers, Novo Nordisk and Amgen.
A mild benefit in the CV outcomes trial of Rybelsus means a likely label expansion in diabetes patients, but probably not vastly increased sales.
The company and partner OncoC4 remain tight-lipped on what’s behind the partial hold in the NSCLC study of gotistobart, which could impact BioNTech’s nascent oncology plans.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The action, taken in consultation with the US FDA, follows the failure of the TROPiCS-04 study, which was the confirmatory trial for the urothelial cancer accelerated approval.
Gilead presented 48-week data for the combination of weekly oral lenacapavir/islatravir, showing results consistent with 24-week data. A Phase III program will soon begin.
Vyalev, a 24-hour constant infusion of carbidopa and levodopa prodrugs, obtained US FDA approval and will launch at $119,000 per year.
Full data from Merck & Co’s Phase IIb/III trial of its novel RSV antibody suggest that it will have to fight hard against Sanofi/AstraZeneca’s leader.