Sanofi SA has taken the unusual step of withdrawing its new drug application (NDA) for the Type 2 diabetes drug, lixisenatide, from the US Food and Drug Administration in order to allow a cardiovascular outcomes study of the drug to finish. The French company said the decision is not related to any safety issues or deficiencies with the application.
Evotec AG, the Hamburg-based drug discovery and development company, has once again joined forces with scientists at Harvard University – this time to identify compounds that could prevent or slow down the loss of motor neurons in disease.
AstraZeneca Plc has moved to further strengthen its position in ovarian cancer with an agreement to in-license a kinase inhibitor from Merck & Co Inc that is currently being evaluated as a combination therapy in patients with certain types of the disease.
Kiadis Pharma BV of the Netherlands has disclosed five-year follow-up data for an allogeneic stem cell treatment for patients undergoing transplantations for leukaemia which showed a survival rate of 67% at the optimal dose. The data has been submitted to a peer-reviewed medical journal for publication.
Anergis SA of Switzerland said that a Phase 2b study of its lead vaccine for birch pollen allergy met the primary endpoint of reducing a symptom and medication score at the lower of two doses. Notably this was shown in a real-life, as opposed to a laboratory setting.
The Debiopharm Group of Switzerland has become the latest company to respond to the global call for new antibiotics with the announcement of an agreement with TCG Lifesciences Ltd to develop treatments for drug-resistant hospital-acquired infections.
Prosensa Holding NV of the Netherlands has started a trial of its fourth antisense oligonucleotide drug for Duchenne muscular dystrophy (DMD), a genetic disorder that causes a progressive loss of muscle strength in patients.
The US Food and Drug Administration has expanded the indication for Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with late-stage pancreatic cancer.
Novartis has expanded its presence in the field of cell therapy with the signing of a research collaboration with Regenerex LLC to investigate applications of the US company’s haematopoietic stem cell-based platform.
ThromboGenics NV is set explore a new target for the treatment of ophthalmic diseases following the signing of an exclusive licensing deal with venture capital-backed Bicycle Therapeutics of the UK. Financial terms were not disclosed.