The US Food and Drug Administration has approved Tanzeum (albiglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist from GlaxoSmithKline Plc for Type 2 diabetes. The approval comes with a requirement for post-marketing studies.
The Roche group expects that core earnings per share will grow faster than sales this year as management continues to drive efficiency across the company. In the first quarter group sales increased by 5% at constant exchange rates, but were down by 1% in Swiss francs.
AAVLife SA, a French start-up company that is using an adeno-associated virus vector to deliver a new gene therapy, has raised $12 million in a series A equity placement led by Versant Ventures Management LLC of Menlo Park, California.
Cytos Biotechnology AG of Switzerland said that its Phase 2b study of a new compound for moderate to severe allergic asthma failed to meet its primary endpoint of a statistically significant reduction in an asthma rating test, and the trial is being stopped.
Spinifex Pharmaceuticals Pty, an Australian developer of chronic pain treatments, has raised US $45 million in a Series C financing round from venture capitalists led by Novo A/S of Denmark and the new investor, Canaan Partners of Menlo Park in California.
In keeping with its role in mapping the human genome more than a decade ago, the Wellcome Trust Sanger Institute is helping organise another large data project – this time with the goal of identifying protein targets for new drugs. Together with the European Bioinformatics Institute and GlaxoSmithKline Plc, the Trust is setting up a new Centre for Therapeutic Target Validation in the UK to collect data relevant to disease.
Edinburgh-based NuCana BioMed Ltd has raised $57 million in a Series B financing round to support the development of cancer medicines that are chemically adapted nucleoside analogues, reportedly with an enhanced ability to trigger cancer cell death.
Newron Pharmaceuticals SpA, which has candidate products for pain and diseases of the central nervous system, has raised CHF 18.6 million (€15.2 million) in a share placement with institutional investors.
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.