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Applied Therapeutics has a business model that defies the conventional wisdom about start-up success: reviving science abandoned by big pharma; financing from a narrow group of investors, dependent on the goodwill of a single academic institution; all in pursuit of a small molecule solution to one of the biggest, diversely complex and cost-defying challenges in chronic disease – the complications of diabetes.
Infographic: In Vivo explores trends in personalized medicine, looking at the 25 new molecular entities approved in the US last year with an individualized aspect.
Genomic medicine is coming of age. For Illumina chief scientific officer David Bentley, that not only means improved technology, accuracy and coverage of gene sequencing and a broadening into cancer, but also a better understanding among the wider population of disease and precisely the benefits that gene sequencing can bring to patients – actual and pre-symptomatic.
Once the stuff of (largely implausible) science fiction, gene therapy is now a clinical reality and one that is taking an increasing share of the pharma R&D limelight. In Vivo takes a look at how these therapies work, how the field has emerged and where it is likely to go next.
US FDA’s latest effort to provide guidance for consumers on pharmacogenomics tests underscores the challenges the agency faces in the absence of a clear regulatory framework for lab-developed tests – and with no easy mechanism to update labels for off-patent drugs.
The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.
Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.
From the general to the particular: drug developers are increasingly tailoring therapies to individuals. Driven by important advances in understanding biology as well as new tools to harness big data, industry participants expect significant progress in biopharma’s approach to the patient.
Since receiving approval for the first broad-panel diagnostic test as a combination product to detect cancer, Foundation Medicine has ramped up its partnerships with pharmaceutical companies and other stakeholders. The company expects to receive a similar approval for a broad-panel liquid biopsy genomic test in the first half of 2020.
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