The US Food and Drug Administration has approved Nerlynx (neratinib), a new drug for lowering the risk of recurrent breast cancer in patients who have been treated with a regimen that includes trastuzumab, the targeted therapy for HER2-positive breast cancer.
An advisory committee to the US Food and Drug Administration has unanimously recommended that the agency approve the first engineered T cell therapy for cancer CTL019. The vote is not binding on the FDA, but the agency usually follows the recommendations of its advisory committees.
Results from a Phase 3 trial of emicizumab, an experimental treatment for haemophilia A, were published online in the New England Journal of Medicine on 10 July. They showed the treatment achieved a clinically meaningful reduction in bleeding episodes in patients with antibodies to factor VIII replacement therapy.
There are multiple strategies underway in oncology to exploit new knowledge about the immune system and destroy tumours. Many of these involve building compounds de novo. But every once in a while a company breathes new life into an existing molecule.
Sanofi has taken steps to broaden its vaccine portfolio with the planned acquisition of Protein Sciences Corp of Meriden, Connecticut, US which has a protein-based influenza vaccine recently approved for the US market.
Shire Plc is advancing a candidate gene therapy acquired from its 2016 purchase of Baxalta, with plans to take the product into a first human trial in patients with haemophilia A. The product is a factor VIII gene therapy delivered in an adeno-associated virus (AAV) vector.
The first new drug for sickle cell disease in nearly 20 years has been approved by the US Food and Drug Administration. The treatment, Endari (L-glutamine oral powder), lowers oxidant damage to red blood cells thereby reducing complications of the disease.
Zealand Pharma A/S of Denmark has become the latest European biotech company to consider listing on the Nasdaq over-the-counter market in the US in order to raise capital to expand its business. The company has one product on the market for diabetes.
Three multiple myeloma studies in which Merck & Co’s checkpoint inhibitor Keytruda (pembrolizumab) was being investigated in combination with drugs produced by Celgene Corp have been stopped following patient deaths, Merck announced on 5 July.
A UK life science incubator located in the city of Nottingham has expanded its premises in order to accommodate more than 700 new bioscience positions over the next 30 years. The expansion will be a significant boost to the economy of the Midlands region of England.