Kite Pharma Inc has published further positive data for its lead chimeric antigen receptor (CAR) T cell therapy for cancer, while confirming that its rolling application to the FDA to receive marketing approval should be complete by the end of the first quarter.
The US Food and Drug Administration has given regulatory clearance for a Phase 1 trial of Cellectis SA’s allogeneic, gene-edited cell therapy for the treatment of refractory acute lymphoblastic leukaemia (ALL). The product is being developed by Servier and Pfizer Inc.
InDex Pharmaceuticals Holding AB, which is developing treatments for immunological diseases, reported unchanged revenue for 2016 and a widening of its operating deficit as it prepares to take its lead product for ulcerative colitis into a proof-of-concept trial.
The coming into force next year of new European rules governing clinical trials will simplify trial application procedures and make more study information available to the public. At a meeting of the European Forum for Good Clinical Practice on 22 February, healthcare professionals discussed how the new rules on transparency should build public confidence in the regulatory system and avoid potentially serious accidents.
Merck & Co Inc is the latest company to abandon a programme for treating patients with Alzheimer’s disease because the treatment failed to show efficacy. On 14 February, the US company said it was stopping a Phase 2/3 study of verubecestat, an inhibitor of beta-secretase 1 (BACE1).
Ergomed Plc has reported positive results from a Phase 2 study of its insomnia drug Lorediplon, a non-benzodiazepine hypnotic drug that modulates the GABAa receptor.
Heptares Therapeutics has launched a research partnership with the University of Cambridge to use its discovery platform targeting G protein-coupled receptors (GPCRs) to identify new drugs for cardiovascular disease.
Early clinical data for a therapeutic protein developed by Ablnyx NV to treat patients with psoriasis has demonstrated that the treatment is safe, with some evidence of a reduction in disease activity. The treatment targets the interleukin-17 (IL-17) pathway.
Enterome SA has started a Phase 1 study of its lead small molecule drug directed at the gut microbiome. The candidate drug targets the FimH protein as a means of blocking inflammation in Crohn’s disease.
A 50-year old patient with recurrent cancer involving tumours in both the brain and spinal cord has been treated with a chimeric antigen receptor (CAR) T cell therapy targeting an antigen that is overexpressed in a majority of glioblastomas.