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.
An undisclosed amount of seed funding has been provided by two UK investors for a start-up gene therapy company that is working on a concept for preventing nerve damage in glaucoma, the leading cause of irreversible blindness worldwide.
Spark Therapeutics Inc said it plans to seek marketing approval in the US next year for a gene therapy following a Phase 3 trial in which the experimental treatment helped restore vision to patients with an inherited eye disorder.
For more than a year, the European Medicines Agency (EMA) has been meeting individually with a number of companies that are developing products for difficult-to-treat diseases to speed the path towards registration. The discussions are non-binding, which means that regulatory approval is not assured. But they give both sides a chance to discuss the requirements of a good clinical programme, including the sort of information that will eventually be needed to show effectiveness in clinical practice.