News

The US Food and Drug Administration has given an accelerated approval to a new therapy for synovial sarcoma, the first engineered cell therapy for a solid tumour to receive a marketing approval. The product, Tecelra (afamitresgene autoleucel), is directed against tumours that express the melanoma-associated antigen A4 (MAGE-A4), a marker for the disease. Synovial sarcoma is a rare type of soft tissue sarcoma which can occur in many parts of the body but most frequently in the extremities. The product was developed by Adaptimmune Therapeutics Plc.

The European Medicines Agency has issued a negative opinion for Leqembi (lecanemab), a treatment for Alzheimer’s disease, saying that the benefits of the drug do not outweigh the risks. The opinion, issued on 25 July, is in contrast to decisions by regulatory authorities in six other countries, including the US, which have all approved the treatment. Leqembi is currently being marketed in the US, Japan and China. Co-developer Eisai Co Ltd said that it will appeal against the decision.

Five years after raising €30 million in a Series A financing round, Confo Therapeutics NV has completed another fundraising – this time for €60 million to advance a pipeline of therapies that modulate G-protein coupled receptors, one of the most difficult set of targets for drug development. The new round was led by Ackermans & van Haaren and included participation from the new investors Driehaus Capital Management and Quest for Growth.

A US medical device company with a product designed to help patients at risk of heart failure has received $196 million in new finance to support the commercialisation of a wearable defibrillator product. Kestra Medical Technologies Inc, which is located in Kirkland, Washington, with a presence in Ireland, is a privately-held company established in 2014. 

The Roche Group reported sales of CHF 29.8 billion ($33.7 billion) in the first half, unchanged from a year earlier on a reported basis but up by 5% at constant exchange rates. With product sales reviving and several regulatory approvals in hand, the company plans to increase its dividend in Swiss francs this year. Further details were not provided.

Sanofi SA ended the second quarter with sales of €10.7 billion, up by 7.8% from a year earlier and propelled by the continuing strong performance of Dupixent, the biologic co-developed with Regeneron Pharmaceuticals Inc. Dupixent generated €3.3 billion in the period, or nearly a third of group sales. Altogether, pharmaceutical products delivered €8.3 billion and vaccines, €1.14 billion. The company’s consumer business, which will be spun out in the fourth quarter, at the earliest, produced revenue of €.1.3 billion.

Following strong growth across its drug portfolio in the first half year, AstraZeneca Plc has upgraded its revenue and profit forecast for 2024 and reaffirmed its target for revenue at the end of the decade. Pascal Soriot, the chief executive, told journalists on 25 July that the company expects to deliver a mid-teen percentage increase in revenue and core earnings per share this year and a revenue figure of $80 billion by 2030. The 2030 forecast would represent a significant increase from the $45.8 billion delivered in 2023.

Mission Therapeutics Ltd of the UK, which is developing therapies targeting mitochondrial dysfunction, has received $5.2 million in grant funding to progress its lead small molecule drug for Parkinson’s disease into early clinical development. The award comes from the Michael J Fox Foundation and Parkinson’s UK and follows the disclosure of promising data from healthy volunteers that the drug, MTX325, has a good safety profile and can penetrate the blood-brain barrier. 

Novartis reported net sales of $12.5 billion in the second quarter, up by 9% from a year earlier on a reported basis, and by 11% at constant exchange rates. Driving growth were double digit increases for five products, and a 133% increase for Leqvio, a drug approved for treating cholesterol. On the strength of the sales increase, the company’s operating income rose by 43% to $4 billion on an IFRS basis. The non-IFRS operating result, excluding amortisation and impairment charges, was $5 billion, up by 17%. Sales’ volumes contributed 15 percentage points to the top line.

A venture syndicate led by Novo Holdings A/S, with participation from EQT Life Sciences, has raised $100 million for Asceneuron SA enabling it to advance a new product for Alzheimer’s disease. Based in Lausanne, Switzerland, Asceneuron is developing a small molecule drug, ASN51, that inhibits an enzyme implicated in the aggregation of proteins in the brain. This is thought to have application for both Alzheimer’s and Parkinson’s diseases, as well as amyotrophic lateral sclerosis.