The Food and Drug Administration has approved a new device for closing small holes in the heart called patent foramen ovales (PFO), which in some patients can be a cause of recurrent strokes. The non-surgical device can be inserted through a catheter in a vein in the leg.
H. Lundbeck A/S, the Danish pharmaceutical company specialising in psychiatric and neurological disorders, has raised its guidance for 2016 following a larger-than-expected increases in sales and earnings so far this year.
Third-quarter results from Shire Plc give a further insight into the financial impact of its acquisition of Baxalta Inc – the company’s biggest acquisition to date. The $32 billion deal, completed on 3 June, comes on the heels of two other multi-billion dollar deals in 2015.
Belgium-based Promethera Biosciences SA, which is developing cell-based treatments for in-born errors of metabolism and acquired liver disease, has raised €10 million in a Series C-extension financing to expand its portfolio.
Transgene SA aims to raise about €48 million in a rights issue and private placement in order to finance the clinical development of its cancer vaccines, three of which will be investigated in combination with immune checkpoint inhibitors.
Barcelona, Spain-based Ysios Capital has raised €126.4 million for a new fund that will invest in biotechnology, medical device and diagnostic companies across Europe, with a special emphasis on Spain. Ysios BioFund II Innvierte is expected to finance up to 15 early-stage companies.
Ablynx NV is poised to consult regulatory authorities in the US and Europe on plans for the Phase 3 development of its biologic for rheumatoid arthritis vobarilizumab. The Belgium-based company will also initiate discussions with potential partners for the drug.
Novo Nordisk A/S plans to become a diversified pharmaceutical company instead of relying mostly on its large diabetes franchise, for which it claims a 27% global market share.
Strong demand for rare disease medicines and early shipments of influenza vaccines to the US boosted third-quarter sales at Sanofi SA, offsetting the loss of income from the off-patent insulin Lantus. As a result, Sanofi upgraded its profit forecast for 2016.
Recruitment for Phase 3 clinical trials of AstraZeneca’s treatment for head and neck cancer, both mono and combination therapies, has been suspended by the US regulator because of bleeding by some of the patients, the UK company disclosed on 27 October.