Developers of stem cell and gene therapies and tissue engineered products have until 31 March to give their views on the effectiveness of EU legislation that defines the regulatory framework for these products, known as advanced therapy medicinal products (ATMPs).
Shire Plc has taken further steps to strengthen its franchise in rare diseases with an agreement to acquire privately-owned Lotus Tissue Repair Inc which has a preclinical product for the treatment of dystrophic epidermolysis bullosa (DEB). Financial terms were not disclosed.
AstraZeneca Plc has entered into a research agreement with Cellular Dynamics International Inc to use the US company’s human induced pluripotent stem cell lines for drug discovery. This is the latest in a series of iPS cell initiatives to be announced since early November 2012.
Two out of the three patients with chronic lymphoid leukaemia (CLL) who were treated with a novel immunotherapy in 2010 remain healthy and in full remission more than two years after treatment, according to University of Pennsylvania researchers.
The Roche Group is to coordinate a new project under the Innovative Medicines Initiative (IMI) under which 1,500 induced pluripotent stem (iPS) cell lines will be generated and characterised for use in the study of disease.
Smith & Nephew Plc of the UK has moved to strengthen its position in wound care with the acquisition for $782 million in cash of most of the assets of privately-held Healthpoint Biotherapeutics of Fort Worth, Texas, US. The acquisition was announced on 28 November 2012.
TxCell SA of France, which is developing cell-based immunotherapies for chronic inflammatory diseases, has raised €12.4 million from existing shareholders and a new investor to finance a proof-of-concept study of its lead product for Crohn’s disease.
The Belgian drug regulator has approved the start of a Phase 3 trial of an autologous cell therapy for patients with chronic heart failure – understood to be the first such trial ever. The therapy was developed by Cardio3 BioSciences SA and the US Mayo Clinic.
Leading institutions in the UK, including the Wellcome Trust, have announced plans to create a repository of induced pluripotent stem cells (iPS) in order to study how genetic variation and defects impact cell behaviour and disease.
UK stem-cell research has received a boost following a decision by the Wellcome Trust and the Medical Research Council to invest £8 million in a new institute for stem-cell biology and medicine. The institute will be located at the University of Cambridge.