FDA approves pan-tumour genomic profiling assay
Roche company Foundation Medicine Inc. (FMI) has been granted FDA approval for a diagnostic multiplex tumour profiling assay, which identifies a broad range of tumour markers in one single measurement.
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Roche company Foundation Medicine Inc. (FMI) has been granted FDA approval for a diagnostic multiplex tumour profiling assay, which identifies a broad range of tumour markers in one single measurement.
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.
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.
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.
GARDP:?Six European states, together with the British Wellcome Trust and South Africa, have pledged €56.5m to help develop new antibiotics that break resistance. The ambitious goal of the Global Antibiotic Research and Development Partnership (GARDP) is to develop and deliver up to four new treatments that enter clinical development within the next six years.

