A new JAK inhibitor for patients with rheumatoid arthritis (RA) has been recommended for approval by the European Medicines Agency. If authorised by the European Commission, it would be the first RA drug to be launched in Europe with this mechanism of action.
France-based Valneva SE, which has a portfolio of commercial and development-stage vaccines, has raised €7.5 million through the private placement of its shares with MVM Life Science Partners LLP, a life science investor based in London, UK and Boston, US.
The cell-therapy company TiGenix NV has raised gross proceeds of $35.65 million in an initial public offering of its shares on the Nasdaq exchange in the US in order to support the clinical development of its allogeneic product portfolio.
The UK is to allow a technique for preventing an inherited disorder known as mitochondrial disease in cases where other treatments are ineffective. The treatment, known as mitochondrial donation, was approved on 15 December.
Noxxon Pharma AG has become the latest company to reach an agreement with Merck & Co Inc to test a portfolio drug with Keytruda (pembrolizumab), the US company’s immune checkpoint inhibitor.
A patient with KRAS mutant metastatic colorectal cancer has been successfully treated with an autologous T cell receptor therapy, suggesting there may be a path forward for tackling difficult solid tumours, according to Kite Pharma Inc.
The Food and Drug Administration (FDA) has approved Maci, an autologous tissue-engineered product for the repair of cartilage defects in the knee, the first product of its kind to be authorised for the US. Maci is manufactured by Vericel Corp, formerly Aastrom Biosciences Inc.
Companies that develop drugs for rare diseases typically expect they will be treating small patient populations. Strategically therefore they might put a premium price on a rare disease medicine in order recover their investment quickly. Or they might sustain a loss on the first drug, hoping to build a lucrative franchise in the future. In both cases, the goal is to deliver a life-saving medicine to patients without alternative treatments.
Negotiations between Johnson & Johnson Inc and Actelion Ltd about a potential transaction have ended without an agreement, the two companies announced. Separately, the Wall Street Journal reported that Sanofi SA is reportedly in talks with Actelion.
UK-based Oxford Nanopore Technologies Ltd has raised £100 million in a private share placement to support the commercial development of its new hand-held device for sequencing whole human genomes at a fraction of the cost of earlier technologies.