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.
The antibody-drug conjugate Blenrep (belantamab mafodotin), which was given an accelerated approval in the US for multiple myeloma in 2020, has failed to show superiority against a competitor molecule in a follow-up Phase 3 study. Announcing the trial results on 7 November, GSK Plc said the ADC did not meet its primary endpoint of progression-free survival. Blenrep was being tested against pomalidomide in combination with low dose dexamethasone.
Galapagos NV is to embark on a new strategic path that will combine its experience in immunology with a bold approach to cell-based therapies for cancer. The strategy was outlined by Paul Stoffels, the chief executive on 4 November, and involves changes to the company’s portfolio and its approach to commercialisation. Dr Stoffels is a former chief scientific officer at Johnson & Johnson Inc who became the Galapagos CEO on 1 April.
The strategy addresses both setbacks and opportunities.
Demand for Novo Nordisk A/S’s glucagone-like peptide-1 (GLP-1) medicines for diabetes remained strong in the first nine months of the year, leading the Danish company to upgrade its financial forecast for 2022. Sales at constant exchange are now expected to increase by 14% to 17% this year, instead of the earlier predicted rise of 12% to 16%. In its latest financial report, Novo said the outlook takes into account periodic supply constraints at some of its manufacturing sites.