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.
The UK antibody developer Kymab Ltd is to lead a consortium of public institutions with expertise in public health to discover a new treatment for infection from the Ebola virus which is spreading through west Africa. The goal is to produce an antibody-based medicine.
Seven experimental medicines intended to treat patients infected by the Ebola virus are not yet ready for authorisation, largely because there is insufficient information about their safety and effectiveness, according to the European Medicines Agency.
Geneva-headquartered Index Ventures has invested £2 million in Stealthyx Therapeutics Ltd, a small British company that has developed an encapsulation technology for delivering biologics to the site of a disease. Stealthyx is a spin-out of Queen Mary, University of London.