Merck & Co Inc and its partner Eisai Co Ltd have discontinued a combination study of Keytruda and Lenvima in head and neck squamous cell carcinoma because it failed to show an improvement in overall survival compared with Keytruda and placebo, the companies announced on 25 August. Called LEAP-010, the Phase 3 trial was intended to explore whether the combination could improve treatment options for patients with recurrent head and neck cancer. The study enrolled 511 individuals.
Mysthera Therapeutics AG made its debut in Switzerland on 21 August with $3.5 million of seed capital and a plan to develop new therapies for autoimmune diseases. The company is being supported by Forty51 Ventures, a Basel-based venture capital firm focused on early-stage investments in biotech with a geographic emphasis on Switzerland, France and Germany.
Data from the first-ever efficacy trial of the shingles vaccine Shingrix in China have shown the product to be 100% effective. The trial included nearly 6,000 participants who were randomised to receive Shingrix or a placebo. No cases of shingles were reported amongst those receiving the vaccine compared with 31 cases in the placebo arm, the developer GSK Plc announced on 23 August.
H. Lundbeck A/S received an uplift in the first half year from two regulatory approvals and the strong performance of its new migraine prevention treatment Vyepti. As a result, the company has upgraded its financial guidance and now expects revenue to increase by 7% to 10% for the year. Overseeing this period of growth will be Charl van Zyl who has been named president and chief executive officer, effective 1 September. Mr van Zyl is an executive at UCB SA of Belgium. He will succeed Deborah Dunsire who has led the company since 2018.
Novo Nordisk A/S ended the half year with sales of DKK 107.7 billion ($15.7 billion), up by 29% from a year earlier, largely due to the strong performance of its glucagon-like peptide-1 (GLP-1) drugs for diabetes and two obesity medicines. Together, the two product groups accounted for more than two-thirds of the company’s sales, helping to offset a decline in revenue from insulins and products for rare diseases. The rare disease portfolio includes drugs for endocrine and rare blood disorders. At constant exchange rates, the increase in group sales was 30%.
A vaccine to prevent lower respiratory tract disease in infants which is caused by the respiratory syncytial virus (RSV) was approved by the Food and Drug Administration on 21 August – the second indication for this product in the US. Abrysvo has also been approved to prevent the same respiratory disease in people 60 years and older. Under the new indication, it will be administered as a single dose injection to pregnant women.
Ipsen SA has received Food and Drug Administration approval to market Sohonos (palovarotene) in the US for the treatment of fibrodysplasia ossificans progressiva (FOP), a rare genetic disease that causes connective tissue such as muscle and tendons to gradually turn into bone. This leads to a progressive loss of mobility and function for those affected. The approval was issued on 16 August and was based on the results of a Phase 3 trial of patients with the disease.
SSI Strategy Holdings LLC, a US-based life science consultancy, is to acquire the NDA Group AB of Sweden in a move that will expand its repertoire of services for pharmaceutical and biotech companies to include regulatory advice as well as support for drug development. The combined group will have a commercial presence across the US and Europe with a capacity to provide services from clinical development to medical affairs and regulation, including the use of real-world evidence to evaluate the effectiveness of new drugs.
Novo Nordisk A/S is to pay up to $1.075 billion in cash to acquire Inversago Pharma Inc of Canada in order to expand its portfolio of assets for treating serious metabolic disorders. The Danish company currently has a leading position in the global market for diabetes and obesity treatments. The acquisition will give it a clinical-stage product for diabetic kidney disease and other assets for metabolic and fibrotic disorders.
Remibrutinib, a small molecule treatment for chronic spontaneous urticaria (CSU), or hives, has met all primary and secondary endpoints in two Phase 3 studies involving more than 900 patients, Novartis reported on 9 August. A final readout of the trials and regulatory submission are expected in 2024. Remibrutinib is a Bruton’s tyrosine kinase (BTK) inhibitor that prevents the release of histamine, a signalling chemical in the immune system that causes itching and swelling on the skin, key features of the disease.