The US Food and Drug Administration (FDA) has rejected a new indication for Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) saying that more data is required. The proposed indication is for BRAF V600 positive metastatic melanoma.
Following news in the UK in early November that a one-year-old baby girl with acute lymphoblastic leukaemia (ALL ) has been put into remission by UCART19, an unapproved therapy that required special permission to use, Laboratoires Servier acquired exclusive worldwide rights to the product and promptly did a deal with Pfizer Inc for the drug’s potential commercialisation.
A new venture capital company with financial backing from the European Investment Fund (EIF) has been launched in Belgium to support start-up and early-stage life science companies in Europe. V-Bio Ventures has raised €63 million in the first closing of its first fund.
Argenx NV, which engineers antibodies originating in llamas, has started clinical development of a fourth antibody with the result that the increase in its research and development expenditure was far larger than the increase in operating income in the first nine months.
With six clinical stage products in its pipeline, one of which recently entered Phase 3, Ablynx NV has moved closer to the goal of becoming a vertically integrated biopharmaceutical company.
Faron Pharmaceuticals Oy of Finland has raised £10 million gross on the AIM market in London in order to help finance a Phase 3 trial of its agent for acute respiratory distress syndrome Traumakine, a recombinant human interferon beta-1a product.
The first monoclonal antibody for multiple myeloma has been approved by the US Food and Drug Administration under its accelerated approval procedure. Darzalex (daratumumab), was developed by Genmab A/S and licensed to Janssen Biotech Inc in 2012.
Scientists at KU Leuven in Belgium have reported success in treating mice with cystic fibrosis with an experimental gene therapy, though they caution that it will be some time before the treatment is ready for human trials.
A team of scientists, led by investigators at the Technical University of Munich (TUM), have produced a theory as to why some experimental antibody therapies for Alzheimer’s disease (AD) have failed to show efficacy in late-stage human trials.
Kuros Biosurgery AG, a Swiss developer of biomaterials, has topped up a CHF 15 million (€13.89 million) financing round that closed for the first time in August, with an additional CHF 5 million from undisclosed investors.