Merus BV has successfully fought off a patent infringement lawsuit brought against it in the US by Regeneron Pharmaceuticals Inc, thus securing freedom to operate in the space for transgenic-mouse based antibody therapeutics. The Dutch company announced the decision on 5 January 2015.
The US Food and Drug Administration has approved a new indication for the cystic fibrosis medicine Kalydeco (ivacaftor) which extends coverage to patients whose disease is caused by the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
The Sweden-based biotechnology company Active Biotech AB has raised SEK 225 million (€24 million) in an oversubscribed rights issue to support development of its clinical-stage portfolio, the lead product of which is in a pivotal trial for multiple sclerosis.
The US Food and Drug Administration has approved Saxenda, a glucagon-like peptide-1 receptor agonist developed by Novo Nordisk A/S for the treatment of weight management in addition to a reduced-calorie diet and exercise.
Pieris AG, of Germany has achieved US funding of $13.56 million and a Nasdaq listing by entering into a reverse takeover.
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).
Roche has halted a Phase 3 trial of the monoclonal antibody gantenerumab in prodromal Alzheimer’s disease patients based on a pre-planned futility analysis. No new safety signals were observed in the trial, which was called SCarletRoAD.
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.
The Roche group is set to broaden its antibody technology holdings with the acquisition of the privately-owned Austrian company Dutalys GmbH which has a new bispecific antibody platform. The deal is valued at up to $489 million including milestones.
Merck & Co Inc has bolstered its oncology portfolio with the acquisition of the privately-held Swiss biotechnology company OncoEthix SA which has a BET bromodomain inhibitor in Phase 1b for the treatment of haematological malignancies and advanced solid tumours.