The Committee for Medicinal Products for Human Use has given positive opinions to seven new medicines including Gilead Sciences’ new treatment for chronic hepatitis C virus infection, sofosbuvir. The EMA issued the opinions on 22 November.
The US Food and Drug Administration has approved Olysio (simeprevir), a new therapy to treat hepatitis C virus infection developed by Janssen Research & Development LLC (Johnson & Johnson) and Medivir AB of Sweden.
The US Food and Drug Administration has approved a new indication for the Bayer/Onyx Pharmaceuticals cancer drug Nexavar (sorafenib), and also authorised a GSK vaccine for the prevention of H5N1 avian influenza.
Barcelona-based Grifols SA has become a strategic investor in TiGenix NV through the purchase of new shares valued at €12 million. The deal brings Grifols, the world’s third largest producer of plasma-derived products, further into the cell therapy arena.
Algeta ASA is considering establishing a third leg to its biopharmaceutical business by possibly in-licensing targeted therapies for cancer. This emerged during a briefing by the Norwegian company for analysts, which was called to discuss the commercialisation of Xofigo, the company’s lead asset. Xofigo is a radiopharmaceutical for men with prostate cancer that has spread to the bone.
Mission Therapeutics Ltd of the UK has raised £20 million in a series B financing round to support the development of enzyme inhibitors that are thought to have the potential of targeting difficult-to-treat cancers. The enzymes are deubiquitylating enzymes involved in the DNA damage response.
Sanofi SA said it is stopping clinical development of the JAK2 inhibitor, fedratinib, following reports of cases consistent with Wernicke’s encephalopathy in patients participating in the trials. Wernicke’s encephalopathy is caused by biochemical lesions of the CNS and is related to vitamin B1 insufficiency.
A capital raising effort by Switzerland-based Cytos Biotechnology Ltd has been successful, raising CHF 24.3 million (€19.7 million) from the placement of 8.1 million new shares with existing and new investors. This was CHF 6.7 million more than expected.
Two US professional heart organisations have issued new guidance for the use of statins for heart disease, recommending that treatment focuses on healthy lifestyle and statins when necessary rather than routine use of low-dose statins to achieve cholesterol targets.
Sales of ChondroCelect, an autologous cell therapy for the repair of cartilage defects in the knee, increased by 21% to €3.1 million in the first nine months of 2013 from a year earlier, the developer, TiGenix NV reported.