A recently created spin-out of GlaxoSmithKline Plc has started a Phase 2 study of a new small-molecule treatment for pain that acts against a sodium channel known as Nav1.7. The company is Convergence Pharmaceuticals Ltd.
The US Food and Drug Administration has approved a new indication for the ulcerative colitis drug, Lialda (mesalamine), for the maintenance of remission in patients with the disease, according to the drug’s sponsor, Shire Plc.
A combination therapy of pertuzumab, trastuzumab and docetaxel for women with HER2-positive metastatic breast cancer has met its primary endpoint of progression-free survival in a Phase 3 study, according to the trial’s sponsor, Roche.
Evolva Holding SA has successfully completed a Phase 1 study of a new small molecule compound that is being positioned to treat people with diabetes at risk of vascular or renal complications. The study involved 32 volunteers.
After a period active deal-making, Wilex AG is positioning itself for some key milestones in the coming months including the reporting of an interim analysis of a Phase 3 trial of Rencarex (girentuximab), its therapy for renal cell cancer.
The European Commission has awarded €5.3 million over four years to a consortium led by Ark Therapeutics Group Plc to investigate the possible use of gene and cell therapy, along with stents, in the treatment of coronary heart disease.
Roslin Cells Ltd has reached an agreement with Pfizer Inc giving the US multinational access to its pluripotent stem cell lines with a view to assessing their potential for specific clinical therapies. Financial terms were not disclosed.
Advanced Cell Technology Inc has announced the dosing of the first patients in each of its two Phase 1/2 clinical trials for eye disorders using retinal pigment epithelial cells derived from human embryonic stem cells (hESCs).
The US Food and Drug Administration has issued a draft guidance for companies that are developing diagnostic tests intended to be used with targeted drug therapies. The document gives the agency’s approach towards the review of these products.
Amgen Inc is set to pay Micromet Inc €10 million upfront as part of a collaboration to research the company’s bi-specific antibody technology against three undisclosed solid tumour targets. Micromet is based in the US but has a research facility in Germany.