The use of antibiotic medicines in animals has dropped sharply in Europe following multiple public policy initiatives and national campaigns, according to the European Medicines Agency. In a report issued on 18 November, the agency said that sales of veterinary antibiotics in animals decreased by 47% in the ten years to 2021 – the lowest level ever reported. The report is based on data from 25 European countries.
The US Food and Drug Administration has approved a new treatment for Type 1 diabetes that can delay the onset of stage 3 of the disease. It is the first therapy for people with the disease who are at risk of having their condition worsen. The drug, Tzield (teplizumab), is an anti-CD3-directed antibody for intravenous use that has been approved for adult and paediatric patients aged eight years and older with stage 2 Type 1 diabetes. The developer is Provention Bio Inc of the US.
Facing stiff competition for its lead cancer product, MorphoSys AG is turning its attention to two Phase 3 trials that, if successful, could give it significant added momentum on the US market. This comes as the German company adjusts its US sales forecast for the product, Monjuvi (tafasitamab), a second-line treatment for diffuse large B cell lymphoma (DLBCL). Sales for 2022 are now expected to be $90 million instead of the previously forecast $90 million to $110 million.
Gantenerumab, a candidate monoclonal antibody for the treatment of Alzheimer’s disease, has failed to slow progression of the disease in a large Phase 3 clinical programme involving 1,965 people across 30 countries, the developer Roche announced on 14 November. The company said it would share its learnings with the scientific community, while continuing to develop and test new diagnostics and prospective medicines for the disease.
A safety review of the Janus kinase (JAK) inhibitor group of medicines for chronic inflammatory disorders has concluded that the drugs should only be used in patients with certain risk factors if no suitable alternatives exist. The review was conducted by the pharmacovigilance risk assessment committee of European Medicine Agency and its conclusions were endorsed on 11 November by the agency’s main scientific committee, the CHMP. The recommendations now go to the European Commission for formal approval.
AstraZeneca Plc won 19 regulatory approvals for its portfolio of biopharmaceuticals in the four months to early November representing a step-change from the recent past. Approvals were evenly distributed across geographies and reflected the company’s global ambitions.
At the company’s third quarter press briefing on 10 November, Pascal Soriot, the chief executive, said AstraZeneca intends to spend a significant proportion of its revenue on R&D going forward as it has in the recent past.
New data have been reported for Jardiance (empagliflozin), a medicine approved to treat Type 2 diabetes in 2014 and subsequently also authorised to treat heart failure. A Phase 3 trial in 6,609 adults with chronic kidney disease has now shown that Jardiance can confer a significant kidney and cardiovascular benefit. When treated with the medicine, the risk of kidney disease progression or cardiovascular death was reduced by 28% compared with a placebo, according to the trial’s sponsors Eli Lilly and Co and Boehringer Ingelheim GmbH.
An experimental therapeutic vaccine for HIV that has been designed for use with other therapies to suppress the virus in the absence of antiretroviral medication has reported positive data from a Phase 1 study. The trial results were published online on 27 October in Nature Medicine. The vaccine’s developer is AELIX Therapeutics SL in Spain which collaborated on the study with Gilead Sciences Inc of the US and the IrsiCaixa AIDS Research Institute in Badalona, Spain.
A study of patients hospitalised for acute heart failure has shown that a strategy involving the rapid up-titration of medications and close follow-up resulted in a significant reduction in all cause death and hospital readmissions. The trial was stopped early for efficacy. The results of the study were published on line in The Lancet on 7 November. Separately, Roche announced that the trial had used one of its diagnostics to identify individuals suspected of having congestive heart failure.
Evotec SE reported an operating loss for the first nine months of the year as costs associated with biologics manufacturing, drug research and development, and staff recruitment outpaced gains in revenue. The German drug developer and service provider had revenue of €510.8 million for the nine-month period, up by 19% from a year earlier. But the cost of sales and other expenses left it with an operating loss of €16.8 million. This compared with a year-earlier profit of €26.1 million.