News

Novo Nordisk A/S has broadened its coverage of the market for diabetes treatments following  the US approval on 17 June of a new indication for Victoza (liraglutide), its glucagon-like peptide-1 (GLP-1) receptor agonist. The new indication is for the treatment of paediatric patients 10 years or older with Type 2 diabetes. Victoza is the first non-insulin drug approved for the treatment of Type 2 diabetes in children since metformin was authorised for paediatric use in 2000. Victoza has been approved to treat adult patients with the disease since 2010.

A research alliance between German BioNTech SE and Genmab A/S of Denmark has yielded its first product – a clinical stage bispecific antibody that is being investigated in patients with metastatic or unresectable malignant solid tumours. Called DuoBody-PD-L1x4-1BB, the jointly developed product started a Phase 1/2a study on 17 June. It has a dual mode of action that combines checkpoint blockade with the conditional stimulation of T cells.

GlaxoSmithKline Plc is to provide $67 million over five years to help establish a new laboratory at the University of California to investigate how gene mutations cause disease and the role gene editing can play in discovering new treatments. The laboratory project is being led by Jennifer Doudna, co-inventor of the Crispr gene editing technology, and Jonathan Weissman, a leader in Crispr screening technology. Hal Barron, GSK’s chief scientific officer, has also played a role in launching the project. Dr Barron has been the CSO at GSK since January 2018.

The UK medical charity LifeArc has provided £1.5 million in seed funding to a four-year old company, Ducentis BioTherapeutics Ltd, that is investigating molecules for treating inflammation and autoimmune disease. Ducentis was co-founded in 2015 by Philip Huxley, an expert in drug discovery, and David Blackbourn, head of the School of Biosciences and Medicine at the University of Surrey, UK to exploit the CD200 axis. CD200 is a glycoprotein expressed on multiple cells and tissues which uses a receptor, CD200R, to transmit signals affecting responses in multiple physiological systems.

The first diagnostic test for Zika virus infection, which can lead to birth defects if contracted during pregnancy, was approved on 23 May by the US Food and Drug Administration. The test, developed by InBios International Inc, is designed to detect antibodies to the pathogen which indicate that the body has generated an early immune response. It is meant to be used for people who show clinical signs of the disease or who have lived or travelled to Zika-infected areas. Prior to this decision, the InBios’ test and others, were authorised for emergency use only.

A new gene therapy has been approved in Europe, paving the way for its use in patients with beta-thalassaemia, a rare blood disorder. The treatment, Zynteglo, uses a lentiviral vector to deliver functional copies of a beta-globin gene into a patient’s haematopoietic stem cells in order to correct for a shortage of beta-globin. It was given a positive opinion by the European Medicines Agency on 29 March and a conditional approval by the European Commission on 29 May.

The US Food and Drug Administration has approved an antibody-drug conjugate from Roche for diffuse large B cell lymphoma (DLBCL), an aggressive cancer that grows quickly in the lymph nodes and may affect the bone marrow, spleen, liver or other organs. The drug targets CD79b, a protein expressed on B cells.

Olivier Brandicourt is to retire as chief executive of Sanofi SA and be replaced by 51-year-old Paul Hudson, head of Novartis Pharmaceuticals. Mr Hudson will take up his position on 1 September marking the third change in Sanofi’s top leadership in a little more than a year.

Evotec SE has expanded a partnership with Celgene Corp to identify new treatments for neurodegenerative diseases using induced pluripotent stem (iPS) cells. This has triggering a milestone payment to the German company of $9 million.

Genmab A/S, one of Europe’s oldest antibody companies, has registered to make a public offering of American Depositary Shares on the US Nasdaq market of up to $500 million. The plans were disclosed on 28 May but as of 6 June the final size of the offering had not been decided. The company is currently listed on Nasdaq Copenhagen and is proposing the US listing to broaden its shareholder base.