FDA approves first Factor X concentrate
A new coagulation factor replacement therapy has been approved in the US for patients with hereditary Factor X deficiency, a condition that is characterised by the failure of the blood to clot normally.
A new coagulation factor replacement therapy has been approved in the US for patients with hereditary Factor X deficiency, a condition that is characterised by the failure of the blood to clot normally.
Novartis has announced plans to acquire one oncology developer and in-license experimental compounds from two other companies in order to bring three new technologies into its immuno-oncology portfolio.
Biotest AG of Germany is taking impairments totalling €84 million against its results following a plunge in US sales of Bivigam, an immunoglobulin product for the treatment of patients with primary humoral immunodeficiency.
Switzerland-based Basilea Pharmaceutica Ltd has filed a registration document with the US Securities and Exchange Commission (SEC) in preparation for a listing of its shares on the Nasdaq over-the-counter market.
Spain-based Minoryx Therapeutics sl, which is developing drugs for rare diseases, has raised €19.4 million in a Series A funding round to progress its lead candidate into the clinic for multiple disorders of the central nervous system.
A proposed treatment for dry eye disease has been turned down by the US Food and Drug Administration pending more clinical data and information on product quality, according to the sponsor Shire Plc. Shire announced receipt of a complete response letter on 16 October.
A proposed treatment for Type 2 diabetes that combines saxagliptin and dapagliflozin has been turned down by the US Food and Drug Administration, the drug’s sponsor AstraZeneca Plc announced on 16 October. The refusal was in the form of a complete response letter.
The US Food and Drug Administration has approved a new drug, Praxbind (idarucizumab), that can be used in emergencies to reverse the effects of a blood-thinning medicine that is commonly administered to patients with atrial fibrillation.
Luxendo GmbH, a start-up medical technology company, has raised €6 million in a Series A funding round to commercialise new microscope technology that enables researchers to create high-resolution images of tissue and living organisims.
Three scientists who successfully mapped the way in which cells repair damaged DNA and protect genetic information from disintegrating were awarded the 2015 Nobel Prize in Chemistry. They are Tomas Lindahl of the Francis Crick Institute in London, UK; Paul Modrich of Duke University School of Medicine, US and Aziz Sancar of the University of North Carolina, also in the US.