The European Medicines Agency (EMA) has won a landmark battle about the amount of data from clinical dossiers that may be made public. The European Court of Justics (EJC) rejected the demand of three drug developers not to publish what they called confidential information under the EMA’s transparency rules.
Global health product development partnership FIND (Foundation for Innovative New Diagnostics) has announced four major diagnostics projects to combat antimicrobial resistance (AMR) in resource-poor settings.
A brand-new survey conducted by auditing and consulting firm PwC and Strategy& has found out that 80% of data protection-prone Germans would share their data in case of being diagnosed with cancer. The results show that cancer could act as a gate-opener to approaches in personalised medicine that depend on the accessiblity of patient data.
US and Dutch researchers have found that carcinogenic E. coli and B. fragilis versions in the gut of patients who developed precancerous polyps early in life trigger development of colon cancer by secreting proinflammatoy signals, depleting mucus and inducing DNA damage.
Using CRISPR-Cas 9 genome editing, US and German stem cell researchers have corrected clustered mutations in the dystrophin gene in heart mucle cells obtained from induced pluripotent stem cells of patients with Duchenne muscular dystrophy (DMD).
Following critisism from the industry, the European Patent Office has drafted a proposal to allow exemptions to its Early Certainty Initiative. Industry associations had pressed the EPO not to limit the time to grant a patent to 12 months arguing it would have detrimental effects on the life sciences sector.
Briefly after Belgian nanobody maker Ablynx rejected a €2.3bn take-over bid of Novo, its board accepted a €3.9bn tender of its R&D partner Sanofi. It’s the second large take-over of Sanofi this month.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) greenlighted seven medicines for approval at its January 2018 meeting, including one orphan medicine, and one biosimilar.
Scientists at the University of Glasgow have found a bacterial strain which blocks dengue and Zika virus transmission from mosquitoes.
Novartis AG has strengthened its ophtalmology portfolio by acquiring a licence for Spark Therapeutics’ voretigene neparvovec (Luxturna), an FDA-approved gene therapy that corrects mutations in RPE65, which leads to juvenile blindness in homozygotous carriers.