The US Food and Drug Administration has issued a draft guidance for companies that may be planning to develop and submit an application for marketing for an artificial pancreas system for people with Type 1 diabetes.
Concert Pharmaceuticals Inc is set to receive a $4 million milestone from GlaxoSmithKline Plc in connection with the selection of a lead HIV protease inhibitor for clinical development. The candidate drug will enter efficacy studies in 2012.
Roche has reported that its investigational treatment for advanced basal cell carcinoma, vismodegib, shrank tumours in a Phase 2 study of patients with locally-advanced disease and those with metastatic disease.
Sanofi SA has entered into a two-year research collaboration with a small Netherlands-based company, Audion Therapeutics BV, to develop potential treatments for hearing loss by targeting progenitor cells in the inner ear with small molecule compounds.
ReNeuron Group Plc has upgraded its collaboration with the Schepens Eye Research Institute in the US with the signing of a patent and licensing deal giving it rights to develop and commercialise human retinal precursor cells (hRPCs).
The US Food and Drug Administration has approved Nulojix (belatacept), a new treatment to prevent organ rejection in adult patients who have had a kidney transplant. The developer is Bristol-Myers Squibb Company.
Immatics Biotechnologies GmbH of Tübingen, Germany has started vaccination of the first patients in a Phase 3 trial of its therapeutic vaccine for renal cell cancer. The primary endpoint is overall survival in combination with sunitinib.
Zealand Pharma A/S of Denmark has reached an agreement with Boehringer Ingelheim GmbH of Germany to develop dual-acting glucagon and glucagon-like peptide 1 receptor agonists for the treatment of Type 2 diabetes and obesity.
Qiagen NV, the Netherlands-based holding company for the German diagnostics company of the same name, is offering to buy Ipsogen SA of France in two stages for approximately €70 million starting with the purchase of a 47% stake.
The European Union’s public-private partnership for drug development research, the Innovative Medicines Initiative, is to formally collaborate with the US Critical Path Institute, in a move to share more information from pre-competitive research.