The European Medicines Agency’s main scientific committee is recommending approval of a stem cell therapy to treat limbal stem cell deficiency. It is the first positive opinion for a stem cell therapy and the fifth for an advanced therapy medicinal product (ATMP).
The Court of Justice of the European Union has issued a decision in a patent case brought by a US corporation which gives a fresh interpretation to restrictions laid down in 2011 on the patentability of human embryos for industrial or commercial purposes.
Pfizer Inc is prepared to commit up to $280 million to an experimental gene therapy for haemophilia which is under development by Spark Therapeutics in the US, while at the same time reinforcing its gene therapy research capacity in the UK.
Novartis and the University of Pennsylvania have issued a clinical update of their cell therapy for paediatric patients with acute lymphoblastic leukaemia (ALL) showing that 36 out of 39 patients, or 92% of trial participants, experienced a complete remission of their disease.
France-based TxCell SA has enrolled the first patient in a new trial of its cell therapy for Crohn’s disease which aims to demonstrate that 160 patients with refractory disease can experience relief. Crohn’s is an inflammatory bowel disease affecting the gastrointestinal tract.
Israel-based Pluristem Therapeutics Inc has entered into a long-term collaboration with the Hadassah Medical Center in Jerusalem to assess the potential efficacy of a cell therapy for the treatment of complications arising from bone marrow transplantations.
Promethera Biosciences SA, a Belgian company developing cell-based treatments for in-born errors of metabolism and acquired liver disease, has raised €20.3 million in a Series C venture capital round and €5 million in loans and subsidies from the regional government of Wallonia.
2015 is expected to be the year in which gene and cell therapy companies produce enough clinical data to give investors a steer on the commercialistion prospects for the industry as a whole.
The US Food and Drug Administration has granted ‘breakthrough therapy’ status to a gene therapy that is in Phase 3 development for patients with an inherited eye disorder that can lead to blindness. The developer is Spark Therapeutics of Philadelphia, Pennsylvania.
Dendreon Corporation, developer of the first ever FDA-approved cellular immunotherapy, announced on 10 November that it had filed for protection from its creditors under Chapter 11 of the US Bankruptcy Code.