The US Food and Drug Administration has given the Novartis vaccine Bexsero, which is designed to protect against infection from meningococcal disease caused by serogroup B, a designation as a ‘breakthrough therapy’. This means it will receive an expedited review.
InDex Pharmaceuticals AB of Sweden has secured a licensing agreement with Almirall SA of Spain giving that company European marketing rights for its lead drug candidate for ulcerative colitis Kappaproct. The agreement comes ahead of the release of top-line data from a Phase 3 study of the therapy in patients experiencing a severe stage of the disease.
An aptamer drug developed by Noxxon Pharma AG has shown positive results in a Phase 2a study of patients with diabetic nephropathy, a complication of diabetes. The drug, emapticap pegol, had beneficial effects on patients even after the cessation of treatment.
The US Food and Drug Administration has approved the first sublingual allergen extract for the treatment of hay fever which is induced by certain grass pollens. The product, Oralair, was developed by Stallergenes SA of France.
Nicox SA continued to strengthen its ophthalmic business in 2013 with an acquisition and the expansion of its US sales force. But significant sales and an end to losses weren’t achieved during the year.
Evotec AG has signed a partnership agreement with the Debiopharm Group of Switzerland to discover and develop novel compounds for the treatment of multiple forms of solid tumours and leukaemias which have defined genetic alterations.
Genomic Vision SA, a French company focused on DNA analysis and genetic testing in cancer and inherited disorders, has raised €23 million with an initial public offering on the regulated market of the Euronext exchange in Paris. The shares start trading on 7 April.
GlaxoSmithKline Plc has decided is to stop a Phase 3 trial of a MAGE-A3 cancer vaccine for patients with non-small cell lung cancer because it has been unable to identify a sub-population that might benefit from the treatment.
SkyePharma Plc is poised to pay off years of fixed-income debt following commitments from institutional investors to buy shares in the company. This is expected to raise gross proceeds of £112 million, sufficient to pay off debt while leaving a residual £8.4 million for future investment. The company announced the capital-raising measures on 31 March, together with the release of its 2013 financial results.
AstraZeneca Plc has agreed to give the Medical Research Council access to its proprietary compound library under a collaboration aimed at identifying promising new candidate drugs. Under the deal, the MRC will fund up to 15 screening projects per year.