Sweden-based Medivir AB has reported positive Phase 2 data for a recently acquired histone deacetylase (HDAC) inhibitor in a trial of patients with early-stage cutaneous T cell lymphoma (CTCL), a haematologic cancer that presents in the skin.
A Phase 3 trial in which patients with active rheumatoid arthritis (RA) were treated with the monoclonal antibody sirukumab, or placebo, met its primary endpoint of relief from swelling even in those who had failed to respond to two or more biological drugs.
An early clinical trial of a candidate treatment for pancreatic cancer developed by Halozyme Therapeutics Inc has been suspended after the independent data monitoring committee determined that it was unlikely to improve the patients’ overall survival.
A Phase 2 study of the monoclonal antibody daratumumab in three types of non-Hodgkin’s lymphoma has been stopped early because it failed to reach predefined targets for overall response, Genmab A/S announced on 30 March.
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.