Pharmaceuticals, Biotechnology and Life Sciences
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.
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.
CTI BioPharma has reported neto loss of $6.4 million for the fourth quarter 2016. Net loss has decreased comparing the same period last year when the company reported net loss of $28.8 million. As for the full year, the company has reported net loss of $52.0 million, which is also decrease comparing last years loss of $122.6 million.
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).
Leonard Bell, founder of Alexion Pharmaceuticals will not stand for reelection as a Board member and will retire as Chairman of the Board and as a Director at the end of his term, effective as of the Annual Meeting of Shareholders scheduled for May 10, 2017.