The US Food and Drug Administration has approved a new hormone replacement therapy for the treatment of complications of leptin deficiency, the first approved therapy for the disease. Myalept (metreleptin) was developed by Amylin Pharmaceuticals LLC.
ThromboGenics NV, which has a novel ophthalmic product on the market in the US, has announced plans to explore its strategic options for the future. It has appointed Morgan Stanley to help with the strategic review process.
An observational study of up to 10,000 patients with suspected coronary artery disease is underway with the goal of finding new biomarkers and disease-related pathways for use in the development of diagnostic tools and treatments for cardiovascular disease.
The European Medicines Agency’s main scientific committee has issued a positive opinion for a new GlaxoSmithKline Plc medicine to treat chronic obstructive pulmonary disease (COPD).
Eli Lilly and Company said that its antibody therapy, ramucirumab, has improved overall survival in patients with non-small cell lung cancer in a global Phase 3 trial. Ramucirumab inhibits the vascular endothelial growth factor receptor 2.
Novartis said that an experimental drug for advanced basal cell carcinoma, the most common form of skin cancer, met its primary endpoint in a Phase 2 study. The treatment, LDE225, is a molecule that regulates the hedgehog signaling pathway.
The European Medicines Agency and the Food and Drug Administration have stepped up their bilateral discussions about common regulatory issues to include monthly teleconferences on drug safety.
Venture-capital backed Novimmune SA of Switzerland has secured CHF 60 million ($66 million) in new capital, its largest financing round in five years. The monies will be used to advance its pipeline of clinical-stage monoclonal antibodies.
A study funded by the Wellcome Trust in the UK has identified a biomarker for depression, the first such biological indicator for the disease. Until now depression has mainly been diagnosed through clinical interviews, a process that can be very subjective.
Cellectis SA has reached an agreement with privately-owned Laboratoires Servier to develop and commercialise allogeneic T cell therapies for cancer. Under the agreement Servier will make an upfront payment of $10 million, and up to $140 million for each of six new products.