A new drug for anaemia in patients with beta thalassaemia, a rare blood disorder, has been approved for marketing in the US following clinical testing which showed that patients receiving the treatment needed fewer blood transfusions than those on a placebo. The drug, Reblozyl (luspatercept-aamt), was authorised by the Food and Drug Administration on 8 November.
Germany-based Affimed NV has priced its previously announced US offering of 12 million shares at $2.50 per common share. After deducting underwriting discounts, the net proceeds are expected to be about $28.2 million. The offering is expected to close on or about 13 November.
Based in Heidelberg, Affimed is a clinical-stage company with three ongoing trials in lymphoma. On 7 November, it announced US Food and Drug Administration approval for the start of a fourth trial in patients with advanced cancers expressing the epidermal growth factor receptor (EGFR).
A new UK-based company has been launched to explore the dark matter of the genome with the goal of identifying antigens for the development of off-the-shelf cancer vaccines and T cell receptor based immunotherapies. Ervaxx Ltd was founded on original research by scientists at the Francis Crick Institute in London and launched on 6 November with $17.5 million in seed and Series A funding from SV Health Investors and an undisclosed global pharmaceutical company.
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.