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.
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.
A syndicate of investors co-led by New Science Ventures LLC of the US is to provide €8 million to Ovizio Imaging Systems, a Belgium-based medical device company that has technology for the real-time three dimensional imaging of living cells.
A new lung cancer drug developed by AstraZeneca Plc and a diagnostic developed by Roche have been approved by the US Food and Drug Administration to identify and treat patients with non-small cell lung cancer whose tumours have a specific gene mutation.