Takeda Pharmaceutical (TYO:4502) touted results from a Phase III trial assessing the efficacy and safety of an investigational subcutaneous formulation of vedolizumab, a gut-selective biologic designed for adults with moderately to severely active ulcerative colitis. The 383-patient Visible 1 pivotal Phase III trial included an intravenous vedolizumab reference arm. Patients who achieved clinical response after six […]
Clinical Trials
Novocure touts Phase II pancreatic cancer pilot study
Novocure (NSDQ:NVCR) today touted the results of a Phase II pilot trial designed to test the feasibility, safety and efficacy of its Tumor Treating Fields therapy in patients with unresectable, advanced pancreatic cancer. The St. Helier, N.J.-based company’s Optune device uses electric fields, called Tumor Treating Fields, to disrupt cell division, inhibit tumor growth and trigger […]
Novaliq touts topline data for dry eye disease drug
Novaliq today touted topline data from the first pivotal trial of its CyclASol 0.1% drug designed to treat dry eye disease. The company is hoping to position its 0.1% cyclosporine A product as advantageous compared to other ophthalmic treatments, noting that its EyeSol technology helps boost the drug’s efficacy and provide an earlier onset of […]
Anthem, Novo Nordisk team up for real-world diabetes drug study
Anthem’s outcomes research unit, HealthCore, and Novo Nordisk (NYSE:NVO) have joined forces to study Novo Nordisk’s semaglutide GLP-1 receptor agonist in people with Type 2 diabetes. The real-world trial is designed to compare the long-term effectiveness of the drug, also known as Ozempic, against 40 other medications among 2,250 adults with Type 2 diabetes. “Because the Sepra […]
Kala seeks FDA nod for dry eye disease drug
Kala Pharmaceuticals (NSDQ:KALA) said today that it submitted a new drug application to the FDA for its KPI-121 0.25% topical product designed for patients with dry eye disease. The Waltham, Mass.-based company noted that roughly 33 million people in the U.S. have dry eye disease and nearly 90% of those patients experience flares in symptoms. Kala […]
Genentech kicks off Phase III trial for eye implant
Roche‘s (OTC:RHHBY) Genentech reported this week that the company launched Phase III trials evaluating its Port drug-delivery implant in patients with wet age-related macular degeneration and the drug faricimab in patients with diabetic macular edema. The company’s Port device is a refillable eye implant designed to continuously release drugs over a period of several months. “Wet […]
Frequency completes enrollment in safety trial for hearing loss drug
Frequency Therapeutics said today that it finished enrolling participants in a single-dose safety trial for its FX-322 hearing loss drug candidate. The company’s drug candidate emerged as part of its Progenitor Cell Activation platform – the combination of small molecules are designed to activate progenitor cells and trigger the formation of new hair cells in […]
Researchers tout use of closed-loop insulin delivery system
At this year’s meeting of the European Association for the Study of Diabetes, researchers reported that use of a hybrid day-night closed-loop insulin delivery system is better than sensor-augmented pump therapy for blood sugar control in people with poorly controlled Type 1 diabetes. The JDRF-funded study included 44 men and 42 women with Type 1 […]
Medherant wins grant to support manufacturing program for transdermal drug-delivery patches
Medherant said today that it was awarded a Medicines Manufacturing Grant from Innovate UK to support the manufacturing of transdermal drug-delivery patches. The company plans to expand its pilot-scale GMP manufacturing program, which is designed to make patches formulated with its Tepi patch tech for clinical trials. Medherant touts its Tepi technology as enabling the […]
Ocugen kicks off dry eye disease trial for nanoemulsion eye drop
Ocugen said today that it launched a Phase III trial designed to evaluate its twice-daily 0.2% brimonidine tartrate eye drop in patients with dry eye disease. Ocugen plans to run two identical Phase III trials of OCU310, enrolling 240 participants per study. The company said it will assess safety and efficacy results after just 28 […]