News

A new antibiotic which has shown activity against pneumonia was cleared for marketing by the US Food and Drug Administration on 19 August. The safety and efficacy of Xenleta (lefamulin) were demonstrated in two clinical trials of 1,289 patients with community acquired bacterial pneumonia.

A second drug has been approved in the US for myelofibrosis, a rare bone marrow disorder that disrupts the body’s normal production of blood cells. The drug, Inrebic (fedratinib), has been authorised for primary myelofibrosis as well as secondary post-polycythemia vera or post-essential thrombocythemia disease.

The US Food and Drug Administration has approved a third cancer drug that targets a genetic driver of cancer, rather than a specific type of tumour. The drug, Rozlytrek (entrectinib), is directed at cancers with neurotrophic tyrosine receptor kinase (NTRK) gene fusions, a fault that can result in the activation of signalling pathways involved in the proliferation of a number of solid tumours. These fusions are known to occur in breast, colorectal, non-small cell lung, pancreatic and thyroid cancers, among others.

A new combination treatment for drug-resistant tuberculosis (TB) has been approved in the US and is under review at the European Medicines Agency. Developed by the Global Alliance for TB Drug Development Inc, it is only the third new drug approved for TB in more than 40 years, and the first to be produced by a not-for profit organisation.

The first half financial results of H. Lundbeck A/S showed a company in transition. While new products for schizophrenia and depression delivered double-digit sales increases, revenue for the company as a whole was down by 9% at DKK 8.5 billion (€1.13 billion) due to genetic competition for Onfi, a treatment for Lennox-Gastaut syndrome, a childhood epilepsy.

Earnings before interest and taxes (EBIT) were DKK 2.3 billion, down by 23%, giving an operating margin of 27.2%, down from 32.4% the previous year.

Novartis has appointed Page Bouchard, an industry veteran, to the role of chief scientific officer at AveXis Inc, a subsidiary at the center of a controversy over data manipulation in relation to the recently approved gene therapy Zolgensma for spinal muscular atrophy (SMA). Dr Bouchard has been with Novartis for 10 years and will take over the roles of CSO and head of research and development at AveXis that were previously held by Brian Kaspar and Allan Kaspar.

Synpromics Ltd, located near Edinburgh, UK, has been acquired by Asklepios BioPharmaceutical Inc (AskBio Inc) of the US in order to create a new gene therapy company with expertise in adeno-associated viral (AAV) vector therapies. Synpromics has expertise in gene control by way of a synthetic promotor technology that enables genes to be switched on and off to control protein production.

Evotec SE set the stage for a further expansion of its drug discovery and development business in the first half year while increasing revenue from its traditional service business. Group revenue was up by 16% to €207.1 million while operating profit rose by 11% to €24 million. The strong first half performance triggered an upgrade in the company’s guidance for 2019.

A trial of four experimental treatments for Ebola virus infection has been stopped early because two of the drugs were more effective in preventing deaths, than the others. The multi-drug trial is being carried out in the Democratic Republic of Congo where an outbreak of Ebola disease has been declared a public health emergency.

Syncona Ltd made two profitable asset sales during its first financial quarter ended 30 June enabling it to invest in a start-up cell therapy company and provide follow-on financing for its clinical-stage gene therapy company Autolus Therapeutics Plc which is listed on the US Nasdaq market.