News

A Phase 3 trial of the kinase inhibitor Alecensa (alectinib) has shown a statistically significant improvement in disease-free survival in patients with early-stage anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer, Roche reported on 1 September. Alecensa is already approved for advanced ALK-positive lung cancer. The latest data have now shown effectiveness in an early disease setting as well. ALC-positive lung cancer is a molecular subset of non-small cell lung cancer with distinct pathological features.

Evotec SE reported a double-digit increase in group revenue for the first six months despite a serious disruption to its business from a cyberattack in the second quarter which affected productivity across the company. Direct costs from the incident were €39.3 million. But this was more than offset by new and continuing business at the start of the year generating revenue for the first six months of €383.8 million, up by 14% from a year earlier.

Novo Nordisk A/S’s weight loss drug semaglutide (Wegovy) has achieved significant reductions in heart failure-related symptoms in people with heart failure with preserved ejection fraction and obesity in the Phase 3 STEP HFpEF trial. Novo announced the trial results on 25 August. They were simultaneously published in The New England Journal of Medicine. The Phase 3 trial is one of more than 12 studies investigating semaglutide, a glucagon-like peptide-1 receptor agonist, at a dose of 2.4 mg per week.

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.