News

The anti-viral treatment Veklury (remdesivir) has been authorised in the US for the treatment of patients with Covid-19 who require hospitalisation – the first coronavirus treatment to receive a full Food and Drug Administration approval. Announced on 22 October, the decision covers the drug’s use for patients 12 years and older. It follows the agency’s more restrictive emergency use authorisation (EUA) for Veklury, issued in May, which will now only cover the drug’s use in young children.

A Swiss start-up, Araris Biotech AG, with new technology for antibody-drug conjugates (ADC), has raised an additional CHF 12.7 million in seed financing to advance its candidate drugs towards the clinic, bringing the total amount raised to CHF 15.2 million. The newest round was led by Pureos Bioventures of Zurich which noted that the company’s technology addresses some of the limitations of existing therapies.

The German unit of Immunic Inc has received a loan of up to €24.5 million from the European Investment Bank to support development of its lead asset as a potential treatment for patients with moderate coronavirus disease. The small molecule drug, IMU-838 (vidofludimus calcium), is also being tested in Phase 2 trials as a treatment for chronic inflammatory and autoimmune diseases, including multiple sclerosis and ulcerative colitis.

A second Phase 2 study of an experimental vaccine for Lyme disease, a bacterial infection transmitted by ticks, has shown an encouraging immunological response in older adults, one of the vaccine’s main target groups, according to the developer Valneva SE.

Two candidate respiratory syncytial virus (RSV) vaccines generated positive data in Phase 1/2 studies, paving the way for the start of Phase 3 trials in the coming months, GlaxoSmithKline Plc announced on 21 October. The first vaccine has been developed for healthy women of child-bearing age, and the second for older adults. A third vaccine for infants is also in development, with data expected to be reported at the European Society for Paediatric Infectious Diseases meeting on 26 to 29 October.

The German biotech Topas Therapeutics GmbH has raised €22 million in a Series B financing round to advance technology for inducing antigen-specific immune tolerance. The technology is thought to have application across a wide range of autoimmune diseases, allergies and a condition known as anti-drug antibodies where the body throws up resistance to the repeated administration of monoclonal antibodies.

Ireland-based Neuromod Devices Ltd has raised €10.5 million in a Series B financing round to to accelerate the European commercialisation of a device to treat tinnitus, a condition in which sufferers experience a ringing in the ears. The device is a bimodal neuromodulation treatment which has received a CE-mark in the EU and is being rolled out in Europe. The company also plans to target the US market with a particular focus on the Department of Veterans Affairs.

A small molecule drug being developed jointly by Galapagos NV and Laboratoires Servier has failed to meet the primary endpoint of a Phase 2 trial in patients with knee osteoarthritis (OA), the two companies announced on 15 October. The candidate treatment, GLPG1972, targets ADAMTS-5, an enzyme implicated in cartilage degradation. Osteoarthritis occurs when the protective cartilage that cushions the ends of bones wears down.

The European Medicines agency is recommending conditional approval of Tecartus (autologous anti-CD19-transduced CD3+ cells) for the treatment of relapsed or refractory mantle cell lymphoma. The chimeric antigen receptor (CAR) T cell therapy is the third medicine of its type to be reviewed by the agency. It follows the 2018 approvals of Kymriah for leukaemia and lymphoma and Yescarta for lymphoma.

Disruptions caused by the coronavirus pandemic depressed sales at Roche in the first nine months of the year but the company responded to the health crisis with the launch of new diagnostics and a partnership with Regeneron Pharmaceuticals Inc to develop an antibody treatment for the disease. In the third quarter, Roche received six medicine approvals in the US, the EU and Japan.