Gilead Sciences Inc is to discontinue studies of magrolimab, a monoclonal antibody targeting CD47 on cancer cells, following evidence that the risks associated with the drug outweigh the benefits. On 7 February the company said it was stopping a clinical programme in haematologic cancers. On 15 February it announced a partial clinical hold on four Phase 2 studies in solid tumours at the request of the US Food and Drug Administration.
A cell therapy for melanoma, the first of its kind, was given an accelerated approval by the US Food and Drug Administration on 16 February for patients whose disease has progressed despite earlier treatment with a checkpoint inhibitor or a personalised cancer therapy. The therapy, Amtagvi (lifileucel), is a tumour infiltrating lymphocyte cell therapy (TIL) which consists of T cells that have been derived from a patient’s own tumour.
An early clinical-stage radionuclide therapy for neuroendocrine tumours received a ‘breakthrough therapy designation’ from the US Food and Drug Administration on 12 February – the first targeted alpha therapy to do so. The therapy, AlphaMedix, is being developed by RadioMedix Inc of the US and Orano Med of France to treat patients with somatostatin receptor expressing gastroenteropancreatic neuroendocrine tumours. Neuroendocrine tumours mostly occur in the gastrointestinal tract and pancreas, but also can be found in other tissues such as the thymus.
The US Food and Drug Administration has approved a new drug for the treatment of eosinophilic esophagitis (EoE), a chronic, immune-mediated inflammatory disease that can cause difficulty swallowing and affect individuals of any age. The drug, Eohilia, is an oral suspension of budesonide which was developed by Takeda Pharmaceutical Co Ltd and shown to be effective in two trials of adult and paediatric patients. The drug was compared with a placebo and administered for a period of 12 weeks. The first study enrolled patients 11 to 56 years of age and the second, 11 to 42 years of age.
Alys Pharmaceuticals Inc, a new company with a preclinical pipeline of candidate drugs for immune-related disorders, was launched on 12 February with $100 million of capital. The company was co-founded by the venture capital group Medicxi and a group of six scientists specialising in immuno-dermatology. The scientific founders are based at institutions in the US, Germany and France and include Craig Mello, professor at the UMass Chan Medical School, US, and winner of a Nobel Prize in 2006 for the discovery of RNA interference.
Novo Nordisk A/S lifted its share of the global diabetes market to 33.8% in 2023 from 31.9% a year earlier driven by demand for its glucagon-like-peptide-1 medicines for type 2 diabetes. These drugs, Ozempic, Victoza and Rybelsus, help manage blood sugar by triggering the pancreas to release more insulin. Novo generated revenue of DKK123 billion ($17.81 billion) from the three medicines in 2023, representing 53% of group sales.
Novo Nordisk A/S has announced plans to increase capacity for the supply of its medicines for diabetes and obesity in a staged transaction under which a subsidiary of its controlling shareholder, Novo Holdings A/S, will take over Catalent Inc, one the world’s largest contract manufacturing organisations (CMO). Announced on 5 February, the deal is expected to complete towards the end of 2024.
AstraZeneca Plc delivered a third consecutive year of revenue growth in 2023 as medicines across three of its therapy areas delivered a double-digit increase and the company launched new products. Speaking to journalists on 8 February, Pascal Soriot, the chief executive, predicted more growth in 2014 and at least 15 new product launches by 2030. “We are seeing growth across all geographies,” he said, adding that this is being driven by new technologies.
Germany-based TVM Capital Life Science has co-led a $16 million Series A financing for Vektor Medical Inc, a US medical technology company that has developed a device for the non-invasive analysis of arrhythmias, a condition characterised by irregular or abnormal heartbeats. The co-investor was Solas BioVentures of the US.
The US Food and Drug Administration is to give a priority review to Arexvy, a vaccine for the prevention of respiratory syncytial virus (RSV) disease, in the new indication for adults from the ages of 50 to 59 years. Developed by GSK Plc, the vaccine is currently approved for adults 60 years and above. If authorised, Arexvy would be the first vaccine to help protect the new age group against lower respiratory tract disease caused by RSV.