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.
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.
Guido Rasi has been appointed to a new five-year term as executive director of the European Medicines Agency following a fresh recruitment process. Prof Rasi had been forced to step down a year ago in the wake of a procedural challenge to his earlier appointment.
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.
The US Food and Drug Administration has expanded the approved uses for Harvoni (ledipasvir and sofosbuvir), a combination pill for chronic hepatitis C (HCV), to include patients co-infected with HIV as well as those with genotype 4, 5 and 6 infections.
Germany-based Curetis BV has raised €40 million in an initial public offering of its shares on the Euronext exchanges in Amsterdam and Brussels for the commercialisation of its molecular diagnostic system for serious infectious diseases.
The US Food and Drug Administration has approved a new combination therapy for advanced melanoma and has advised physicians to test for certain genetic mutations before prescribing the drugs. Both treatments are marketed by Genentech (Roche).