Two Phase 3 trials which were seeking to show the superiority of a new combination treatment for patients with age-related macular degeneration (AMD) compared with the use of the licenced drug Lucentis alone, have failed to show an added benefit.
ReNeuron Plc has reported positive data from a Phase 2 trial of its allogeneic cell therapy for patients disabled by a stroke and plans to apply to regulatory authorities in the US and Europe to begin a pivotal study that could lead to possible registration.
The cell-therapy company TiGenix NV has announced plans to make an initial public offering of its shares on the Nasdaq exchange in the US in order to raise money for the clinical development of its portfolio. The company is already listed on Euronext Brussels.
Spark Therapeutics Inc has agreed to make a $10 million cash payment plus an equity investment in Selecta Biosciences Inc for access to a nanoparticle technology that could be used to modulate the immune system and allow repeat dosing of a gene therapy.
Novartis said that its chimeric antigen receptor (CAR) T cell therapy, developed jointly with the University of Pennsylvania, achieved significant disease remission in paediatric and young adult patients with B cell acute lymphoblastic leukaemia.
Boehringer Ingelheim GmbH and Eli Lilly and Company have won a second indication for their jointly developed diabetes drug Jardiance (empagliflozin) which belongs to a new class of drugs known as sodium glucose transporter 2 (SGLT2) inhibitors.
UK researchers have reported sequencing the whole genomes of a human donor and a patient using a hand-held device based on nanopore technology. The device was developed by Oxford Nanopore Technologies Ltd, a venture capital-backed company based in Oxford UK.
Switzerland-based Actelion Ltd and Johnson & Johnson Inc have confirmed that they are in discussions about a “potential transaction.” This is the second negotiation involving Actelion in a little over a year.
Solanezumab, a monoclonal antibody that was being tested in patients with mild dementia due to Alzheimer’s disease, won’t be submitted for registration following the drug’s failure to meet its primary endpoint in a Phase 3 trial, Eli Lilly and Company announced on 23 November.
Juno Therapeutics Inc of the US suspended a trial of its chimeric antigen receptor (CAR) T cell therapy for leukaemia for a second time on 23 November following the deaths of two patients from cerebral edema.