The US Food and Drug Administration has approved a new diagnostic capable of detecting antiretroviral drug resistance mutations in people living with the human immunodeficiency virus (HIV) Type 1. The test is able to detect mutations from a simple blood test that uses next generation sequencing to identify the genetic alterations.
The immunosuppressant Cosentyx (secukinumab) narrowly missed statistical significance for superiority in a head-to-head trial against Humira in patients with active psoriatic arthritis, Novartis announced on 1 November. The 52-week trial, called EXCEED, evaluated the two drugs in more than 800 patients who were naïve to a biologic therapy.
Novo Nordisk A/S has raised its sales forecast for 2019 following the strong performance of its glucagon-like peptide-1 (GLP-1) analog, Ozempic (semaglutide) for diabetes in the first nine months of the year. Group sales are expected to increase by 5% to 6% at constant exchange rates compared with earlier expectations for a rise of 4% to 6%. In the first nine months, Ozempic sales reached DKK 6.9 billion (€920 million), bringing its US market share for patients starting a drug for the first time up to 37%.
Swedish Orphan Biovitrum AB (Sobi) ended the third quarter with plans to acquire the US specialty pharma company Dova Pharmaceuticals Inc, as well as to opt in to a development collaboration with Sanofi SA for the experimental haemophilia drug BIVV001. Guido Oelkers, the company’s chief executive, described the moves as an opportunity to expand the company’s rare disease franchise into haematology.
Sanofi SA increased sales by 1.1% to €9.5 billion in third quarter, supported by strong growth of the immunology drug Dupixent and medicines for rare diseases. But vaccines, the company’s third largest business unit, were held back by the late delivery of influenza product to the US. The company’s operating profit of €2.13 billion was down by 21.4% after taking into account restructuring and amortisations, as well as impairment charges.
The safety committee of the European Medicines Agency is recommending that new restrictions be placed on the use of the multiple sclerosis drug Lemtrada (alemtuzumab) in light of reports of rare but serious side effects, including deaths. The latest recommendations replace temporary measures issued in April. They will be considered by the agency’s main scientific committee for a formal opinion.
A second experimental Ebola vaccine is to be tested in a large clinical trial in the Democratic Republic of Congo (DRC) as public health authorities mobilise resources to contain an outbreak of Ebola virus disease, declared by the World Health Organization to be a public health emergency.
Like many developers of cancer drugs, MorphoSys AG is using data from a single-arm Phase 2 trial as the basis for a regulatory submission to the US Food and Drug Administration. The company’s L-MIND trial reported positive results in May showing that the antibody tafasitamab, combined with the myeloma drug lenalidomide, met its primary endpoint of objective response in patients with lymphoma. This is the basis of a rolling submission to the FDA.
GlaxoSmithKline Plc expects to make regulatory filings for three new oncology drugs by the end of 2019, all of which reported positive data in the third quarter. The regulatory plans were highlighted by Emma Walmsley, the chief executive, in a teleconference on 30 October where she also announced an upgrade of the company’s earnings guidance.
Adjusted earnings per share, which exclude amortisations and impairments, are expected to be flat at constant exchange rates, rather than down. The dividend is expected to be unchanged at 80 pence per share.
A vaccine designed to reduce the incidence of pulmonary tuberculosis in HIV-negative adults has shown an overall efficacy rate of 50%, according to the developers GlaxoSmithKline Plc and the international AIDS vaccine initiative (IAVI). The Phase 2b study enrolled adults with latent TB infection, which is estimated to affect one-quarter of the global population. Of this number, an estimated 10% will develop active pulmonary TB disease.