The US Food and Drug Administration has issued a ‘complete response letter’ to GlaxoSmithKline Plc rejecting the company’s application for a third indication for mepolizumab (Nucala). The application was to use the drug as an add-on treatment for patients with chronic obstructive pulmonary disease (COPD).
Announcing the rejection on 7 September, GSK said the FDA is requiring more data to support the proposed indication.
Nicox has begun a Phase 2 study of a candidate treatment for glaucoma designed to secure a position in global ophthalmology. The treatment, NCX 470, is being tested in patients with open-angle glaucoma, the most common form of glaucoma, accounting for about 90% of all cases.
As part of an ongoing out-licensing policy, AstraZeneca Plc has reached an agreement to transfer a candidate product for multiple system atrophy to Biohaven Pharmaceutical Holding Company Ltd of the US for further clinical development and commercialisation. The product, AZD3241, has completed a Phase 2a clinical study.
Two US institutions have taken steps to simplify the regulation of gene therapy, and bring the oversight of these technologies into the existing framework for monitoring experimental medicines. The shift in policy is described by Francis Collins, director of the National Institutes of Health, and Scott Gottlieb, commissioner of the Food and Drug Administration, in an article in the New England Journal of Medicine on 15 August 2018.
AstraZeneca Plc has announced that a Phase 3 trial of its proposed antibody treatment for systemic lupus erythematosus (SLE) failed to meet the trial’s primary endpoint of showing a statistically-significant reduction in disease activity as measured at 12 months by a responder index. Called TULIP 1, the trial was a double-blinded, 52-week placebo-controlled study evaluating the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.
Pfizer has stopped two clinical studies that were evaluating a proposed antibody treatment for Duchenne muscular dystrophy (DMD) because of lack of efficacy. The first study was a Phase 2 trial testing the treatment for safety and efficacy, while the second was an open-label extension study, the company announced on 30 August.
The glucagon-like peptide-1 (GLP-1) analogue semaglutide has demonstrated an ability to promote weight loss in people without diabetes, in some cases up to 13.8%, when combined with diet and exercise. The data comes from a Phase 2 trial comparing semaglutide with liraglutide, another GLP-1 analogue, and with placebo.
Roche’s Genentech has committed funding of $96 million to Affimed NV for rights to the German company’s biologics platform for the production of cancer therapies targeting natural killer (NK) cells in the innate immune system. The platform can generate antibodies directed against NK cells as well as against T cells of the adaptive immune system.
A study in Plos Biology by researchers from the Helmholtz Zentrum München and the Ludwig-Maximilians-Universität München has described a metabolic network in mice that is not controlled by the brain but rather by the ‘circadian clock’ inside muscle cells.
The inference of this discovery, reported on 10 August, is that diseases like diabetes and obesity are influenced by the body’s internal clock rather than just the endocrine system or the brain.
Scientists in Vienna, Austria have used organoid technology to grow brain tumours in the laboratory, enabling them to replicate the process of brain carcinogenesis, potentially making the discovery of new biomarkers and treatments for these cancers easier.