The decision of the vaccine arm of French drug giant Sanofi was based on an independent interim analysis of a pivotal Phase III study enroling up to 16,500 people at risk of Clostridium difficile infection (CDI) for vaccination with the jab that has FDA Fast Track designation.

OPIS   Accelerated approval for orphan drugs and the possibility to have market authorisation
after a successful Phase II trial have made research in rare diseases more attractive to sponsors.
However, challenges and uncertainties remain numerous and designing scientifi cally robust,
patient-centered trials requires proper conceptualisation.

Shire has received FDA Orphan Drug Status for its anti-MAdCAM Antibody SHP647 to treat pediatric ulverative colitis.

845 medical affairs and biopharma industry professionals at Veeva Commercial & Medical Summit Europe in Madrid discussed how digitalisation can speed up the development of new medical solutions while reducing cost.

For years, neurologists have hunted for the source of cell toxicity that drives neurodegeneration and cognitive decline in Alzheimer’s disease. An Indian researcher at the University of Zurich might now have solved the mystery. It’s not hidden in amyloid plaques, as researchers previously believed, but in the microglia, the brain’s innate immune system, which triggers loss of synaptic junctions resulting in loss of cognitive functions. 

Belgian liquid biopsy specialist Biocartis Group NV has pocketed €80m through an equity placement by offering 6.4 million new shares.

French green chemistry specialist Global Bioenergies announced the delivery of a first batch of sustainable cosmetic ingredients to cosmetics heavyweight L’Oréal. It was produced as part of the ISOPROD project, supported by the French State’s Investissements for the Future Program.

In the past, the role of customised and tailored formulations have been largely underestimated in the field of biopharmaceutical product development. An advanced formulation strategy can strongly improve the product, leading to significant customer benefits. The growing and increasingly competitive biopharmaceutical market requires individual solutions, particularly for better product stability and prolonged shelf life.

Three innovative biotech companies have baged the prestigious EuropaBio SME Awards for their innovative business models.

The same bacteria present in primary tumours of patients with colorectal cancer are also present in liver metastases, according to a new study. What’s more, presence of the bacteria was found to correlate with tumour growth.