Pharmaceuticals, Biotechnology and Life Sciences
Lexicon Pharmaceuticals’ Xermelo was recently approved with orphan status by the Food and Drug Administration (FDA) and Diplomat, the USA largest independent specialty pharmacy, will fill prescriptions for it, as it has been selected to the limited-distribution panel of the drug.
Patients with eosinophilic inflammation that were treated with GSK’s mepolizumab Nucala as addition to the standard care, reached improvements in health and lung function compared to patients treated with placebo added to the standard care.
Herantis Pharma clinical study with the company’s innovative gene therapy investigational product Lymfactin for the treatment of secondary lymphedema has advanced to highest planned dose level owing to good reported safety.
Futura Medical has filed a new formulation patent for its topical gel for the treatment of erectile dysfunction, with the UK Intellectual Property Office in connection with MED2002.
AB Science has recruited 350 patients for the phase 3 study (AB07015) in severe persistent asthma uncontrolled by oral corticosteroids, for which the final results will be available at the end of 2017.
Amryt is on track to begin the phase 3 trial at the end of March for its new skin healing treatment in an orphan disease, with regulatory authority discussions now completed with Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the design of the clinical trial established.
Abzena, a life sciences group providing services and technologies enabling the development and manufacture of biopharmaceutical products, has reported that one of the ‘Abzena inside’ Composite Human Antibody products for the treatment of neurodegenerative conditions has moved to Phase II clinical trial.
Novartis has reported new analysis showing that moderate-to-severe psoriasis patients treated with Cosentyx (secukinumab) rapidly regain clear or almost clear skin (Psoriasis Area Severity Index, PASI 90 to 100) following relapse during a treatment pause. Also showed no anti-secukinumab antibodies were observed during retreatment.
Novartis’s division Sandoz has reported that Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating biosimilar adalimumab GP2017 has equivalent efficacy to the reference medicine, Humira.
TiGenix has received the Day 180 List of Outstanding Issues (LoOI) from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and expects to receive a Marketing Authorization decision for Crohn’s disease drug Cx601 in 2017.