© Sartorius

Rapid detection of total bacteria within 2½ h.

© Vetter

Considering the high development costs of medications and the time invested before a drug goes from discovery to market, it is critical to develop not only a solid drug development strategy, but a contemporary manufacturing strategy as well. A parallel development strategy could be one possible approach.

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.

C. difficile is emerging as a leading cause of life threatening, health-care acquired infections worldwide. © CDC

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.

Picture © OPIS

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.

SHP647 mode of action: the antibody blocks integrin on B- and T-lymphocytes to attach to endothelial protein MAdCAM, which would translocate the leukocytes to the GI tract. © https://doi.org/10.2147/BTT.S71679

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

Veeva's CEO Peter Gassner presenting at the European Summit in Madrid. The event saw 875+ healtcare professional attendees, and 118 life sciences companies onsite - with the vital interest to lower cost through more efficient engagement with doctors, regulators and payors.

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.