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Immuno-oncology has significant diagnostic needs including identifying patients most likely to respond to therapies. Current diagnostic approaches often fall short, due in large part to the complexity of the biology driving therapy responsiveness. As such, the biopharma industry is exploring many emerging approaches covering tumor, immune and even microbiome-related pathways and biomarkers.
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The quality of clinical trials and data analysis have come a long way in the past 10 years – and even in the past three, says Christian Hebenstreit of Medidata, the cloud-based platform that supports pharma and medtech companies through clinical studies ahead of their commercial uptake. The buzzwords of the fairly recent past are now being applied as real tools in the clinical trials arena, and look set to transform the sector.
The EU Medical Device Regulation (MDR) is front and center for global medtech companies wanting to succeed in the EU in the next decade and beyond. Or at least it should be, but the fear is that smaller players are not ready for its stringent clinical trials regulations and many other key changes it will bring. The potential impact on the medtech ecosystem and the flow of innovation in Europe is becoming a serious concern.
Mesenchymal cell specialist Mesoblast came back from a near-death experience in 2016 when Teva returned a key asset. But recent success in a Phase III trial in acute GVHD has brought it some attention. Now it needs to repeat the achievement in advanced heart failure and find a partner for its burgeoning pipeline.
Commitment by biopharma to the development of new abuse-deterrent formulations of opioid pain medications is hampered by unresolved issues of development complexity; cost and willingness of payers to reimburse; and regulatory requirements for extensive, industry-financed postmarketing studies. Less addictive alternatives to existing opioid drugs that effectively address the overdose challenge where it’s particularly lethal – through injecting and inhaling rather than oral formulation abuse – are unlikely to enter widespread use anytime soon.
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