Clinical Research

New guselkumab data in plaque psoriasis

New longer-term data from a Phase 3 trial of the drug guselkumab for plaque psoriasis has shown that patients achieved consistent rates of skin clearance following treatment at both 52 and 100 weeks, according to the developer Janssen Research & Development LLC.

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Location

United States

Prostvac trial declared futile

A Phase 3 trial of the Bavarian Nordic A/S candidate vaccine for prostate cancer, Prostvac, has been declared futile based on the results of a preplanned interim analysis. The trial’s independent data monitoring committee is recommending the study be discontinued. 

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Location

Denmark

Gene therapy trial featured

A Phase 3 trial of a candidate gene therapy for retinal disorder has been highlighted in The Lancet as a possible standard for future trials of genetic medicines. The trial was conducted by Spark Therapeutics Inc whose therapy, voretigene neparvovec, is under review at the US Food and Drug Administration.

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Location

United States

Canakinumab reduces cardiovascular risk - Novartis

Phase 3 trial results of canakinumab (Ilaris), a monoclonal antibody that targets interleukin 1 beta (IL-1 beta), have shown a significant 15% reduction of major cardiovascular events in people with a prior heart attack and inflammatory atherosclerosis.

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Location

Switzerland

Stronger survival data for Kyprolis - Amgen

Amgen Inc said that its licensed drug, Kyprolis (carfilzomib), produced a better survival benefit in a Phase 3 trial of patients with relapsed or refractory multiple myeloma than Velcade (bortezomib). The trial results were published in The Lancet Oncology on 23 August.

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Location

United States

Regeneron stops development of antibody for RSV

Regeneron Pharmaceuticals Inc has stopped development of suptavumab, a candidate antibody for the treatment of respiratory syncytial virus (RSV) in infants following the failure of a Phase 3 trial to prevent medically- attended infections.

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Location

United States

Positive data for Galapagos fibrosis drug

A Phase 2a study of a drug developed by Galapagos NV for patients with idiopathic pulmonary fibrosis has halted the progression of the disease in a randomised, placebo-controlled study. Galapagos said it is making plans for a late-stage trial.

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Location

Belgium

Roche haemophilia A study in NEJM

Results from a Phase 3 trial of emicizumab, an experimental treatment for haemophilia A, were published online in the New England Journal of Medicine on 10 July. They showed the treatment achieved a clinically meaningful reduction in bleeding episodes in patients with antibodies to factor VIII replacement therapy.

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Location

Switzerland

Shire advances gene therapy

Shire Plc is advancing a candidate gene therapy acquired from its 2016 purchase of Baxalta, with plans to take the product into a first human trial in patients with haemophilia A. The product is a factor VIII gene therapy delivered in an adeno-associated virus (AAV) vector.

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Location

Ireland

Deaths in Keytruda trials prompt clinical hold

Three multiple myeloma studies in which Merck & Co’s checkpoint inhibitor Keytruda (pembrolizumab) was being investigated in combination with drugs produced by Celgene Corp have been stopped following patient deaths, Merck announced on 5 July.

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Location

United States

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