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.
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.
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.
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.
XW Laboratories has partnered up with the University of Pittsburgh on commercialization of certain compounds based on pioneering mitochondria targeted bis-nitroxide technology developed in the laboratory of Professor Peter Wipf.
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.
ALK has named Hendrik Nolte new R&D strategist in North America and International markets including China, and will work in collaboration with ALK’s partners for Russia, Japan, South-East Asia, Australia and New Zealand, Denmark-headquartered company said Friday.
Sanofi’s vaccines global business unit Sanofi Pasteur has signed a deal with AstraZeneca’s biologics bramch MedImmune, to make and sell a monoclonal antibody-called MEDI8897-for the prevention of the most common reason for lower respiratory tract infections in newborns and infants, Respiratory Syncytial Virus (RSV).
First pharmaceutical cannabis factory was open in the USA on Tuesday, as Ultra Health, New Mexico’s first cannabis company with a nationwide presence, and Panaxia Pharmaceuticals Industries Ltd, an Israeli pharmaceutical company specializing in pharmaceutical cannabis R&D and manufacturing launched their facility in Bernalillo, New Mexico.