More than a decade ago, the US Food and Drug Administration approved an autologous cellular therapy, Provenge (sipuleucel-T), to treat prostate cancer. At the time, it was the first therapeutic cancer vaccine to be approved in the US. Developed by Dendreon Corp, the vaccine later changed hands twice, entering the portfolio of a private Chinese conglomerate, Sanpower Group in 2017.
Covid-19 vaccines manufactured by Moderna Inc and Pfizer Inc have been updated and approved by the US Food and Drug Administration to include a component targeting a new strain of the SARS-CoV-2 virus. The update is the latest move by health authorities to better protect the population against variants of the virus which could lead to hospitalisation or even death.
Genmab A/S has raised its financial guidance for 2024 in light of stronger than expected royalty income from its two leading antibody drugs which are out-licensed to Janssen Biotech Inc and Novartis. Revenue for the year is now expected to be in the range of DKK 20.5 to DKK 21.7 billion ($3.06 to $3.23) compared with an earlier forecast of DKK 18.7 to DKK 20.5 billion. Sales by Janssen of Darzalex (daratumumab) for multiple myeloma, and by Novartis of Kesimpta (ofatumumab) for multiple sclerosis, delivered royalty income of DKK 7.67 billion in the first half year – an increase of 30%.
GSK Plc has received a new indication from the US Food and Drug Administration for its endometrial cancer medicine Jemperli (dostarlimab) that significantly increases the scope of its coverage. Jemperli is a checkpoint inhibitor that has already been approved for three endometrial cancer indications and for the treatment of patients with mismatch repair-deficient advanced solid tumours. Mismatch repair is a process that corrects errors during the replication of DNA. When this process fails, it can cause cancer.
Supported by $1 billion from a recent equity offering, Zealand Pharma A/S is planning to increase investment in its obesity portfolio and broaden its partnerships with other pharmaceutical companies. The Denmark-based company, which was founded in 1998 to produce peptide-based medicines, has already invented 10 medicines, two of which are on the market. Going forward it will progress three late-stage clinical candidates and invest in new assets.
Evotec SE simplified its structure and reduced staff in the first half of 2024 in response to a slowdown in its traditional drug services business. At the same time, there was an increase in its newer biologics manufacturing business with the result that group revenue rose by 2% to €390.8 million compared with €383.8 million a year earlier. Revenue from the service business, which accounts for 77% of total turnover, was down by 7% but income from biologics manufacturing was up by 50%.
Two clinical stage biotech companies with drug discovery platforms based on artificial intelligence are to merge, creating a company with a portfolio of wholly-owned assets as well as collaborations with five big pharma companies. Recursion Pharmaceuticals Inc of Salt Lake City, US, is to have a 74% stake in the new company, which will take the Recursion name and be led by Chris Gibson, the current Recursion chief executive. The partner is Exscientia Plc of Oxford, UK, a smaller AI company founded in 2017 to focus on small molecule drug design.
A new product designed to reduce proteinuria, a feature of a rare disease potentially affecting kidney function, has been given an accelerated approval by the US Food and Drug Administration. The product, Fabhalta (iptacopan), is a small molecule developed by Novartis and the first of several assets from its portfolio of drugs for rare kidney diseases. The FDA approval was announced on 8 August and is based on interim data from a Phase 3 trial investigating Fabhalta in comparison with placebo in patients with primary immunoglobulin A nephropathy (IgAN).
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.