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Flatiron Health was formed to exploit a previously untapped source of real-world data on the treatment and clinical outcomes of cancer patients. The company is now working with most of the major players in the oncology sector as well as with the FDA to maximize the benefits of such data analytics.
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Germany's new testing and treatment methods (NUBs) scheme for assessing benefit in high-risk products for inpatient use recently processed its first batch of applications. But, as with its longer-established outpatient products counterpart, it does not seem to be an instant success, says German reimbursement expert Ben Modley.
The US Veterans Administration is attracting more interest from drugmakers seeking to grow their foothold in the lucrative – but scientifically challenging – market for CNS disorders. The allure comes from VA’s strong analytics and data crunching capabilities as well as its investigatory and trial management expertise in high-profile areas like traumatic brain injury, post-traumatic stress and major depression.
Personalized medicine is becoming the hallmark of care in oncology, but its use is also increasing in other therapeutic areas including inflammation, respiratory, infectious diseases and central nervous system disorders, as scientific understanding of these diseases advances. The expansion of companion diagnostics beyond oncology has impacts on dealmaking, clinical practice and the R&D pipeline.
Flex Health Solutions' role in the medtech space is helping other companies develop superior products for the broadest market appeal. Its ability to source ideas for medical design from other parts of its $24 billion business means it is already leveraging the Fourth Industrial Revolution, just at the point that the industry is undergoing dramatic change.
For the biopharma industry, nothing is more important than patent protection in preserving that vital license to operate, especially now that IP is a key component of the global supply chain. Pfizer’s chief IP counsel Roy F. Waldron provides an overview of industry strengths and vulnerabilities – and what to do about them – as the IP policy front moves forward in 2017.
No significant trends emerged in diagnostics M&A or financing this past year, which did see the introduction of several government-funded initiatives, elements of which will bolster diagnostics innovation. As in other sectors of health care, the biggest question is how the incoming Trump administration could change US regulatory and funding policies.
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