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Clinical Trials
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
Sun launches tildrakizumab, its star psoriasis therapy in India seven years after US FDA approval at what’s seen as a carefully calibrated price point. Can it ruffle entrenched products like secukinumab?
The company will exclude data from patients at the “small number” of sites that experienced irregularities and enroll new patients in their place.
Portugal has made permanent a pilot aimed at cutting review timelines for certain clinical trial applications.
In the head-to-head Phase III HARMONY trial in metformin-failed type 2 diabetes, HighTide's HTD1801 yielded a mean 1.12% reduction in HbA1c from baseline at 24 weeks, versus 0.93% for AstraZeneca’s Farxiga.
France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.
Despite moves made by other developers to limit biosimilar trials – as regulators around the world move towards more streamlined models – Samsung Bioepis says it is sticking with a Phase III trial program for its SB27 proposed Keytruda (pembrolizumab) rival, having just completed recruitment.
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.
“Tubulis is not a single-asset company… It’s an innovation powerhouse,” said CEO Dominik Schumacher in an interview with In Vivo. He outlined the company’s clinical progress, funding momentum and how Tubulis will navigate the competitive biotech market in 2026.
In 2024, trial initiations shifted following the post-pandemic decline in COVID-19 studies. Cardiovascular trials showed the greatest growth by therapeutic area but trailed the previous year’s initiation levels.
Sichuan Biokin Pharmaceutical's BMS-partnered bispecific antibody-drug conjugate iza-bren had met both endpoints of PFS and OS in a China-only Phase III trial for the second-line treatment of esophageal squamous cell carcinoma.
The company announced positive Phase II results for tradipitant among patients taking Wegovy, enabling them to move more quickly to a therapeutic dose, when patients normally need to titrate.