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Personalized Medicine

Set Alert for Personalized Medicine

Going Back To The Future To Treat Diabetes

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. 

C-Suite Speaks Innovation Research and Development Strategies

One For All Not All For One With Personalized Therapies

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. 

Personalized Medicine Research and Development Strategies Research & Development

Illumina CSO Bentley Paints A Vision For The Future Of Precision Medicine

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.

C-Suite Speaks Leadership Personalized Medicine

In Vivo’s Quick Guide To Gene Therapy

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.

Gene Therapy Innovation Research and Development Strategies

More on Personalized Medicine from Scrip, Pink Sheet & Medtech Insight.

Pharmacogenetic Tests: US FDA Tries Off-Label Approach To Guide Consumers

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.

Personalized Medicine Regulation

HHS Advances AI Priorities In Budget Ask

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.

Regulation Policy

US FDA’s Precision Medicine Efforts Turn Towards Adverse Events

Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.

Drug Safety Personalized Medicine

Scrip Asks… What Does 2020 Hold For Biopharma? Part 4: The Patient

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.

Personalized Medicine Artificial Intelligence

Blueprint Medicine Gains US Approval For First Drug, Precision Medicine Ayvakit

The FDA has granted full approval to the drug based on Phase I efficacy data and safety studies, reflecting lack of existing treatment options
Approvals FDA

Partnerships Are Key To Foundation Medicine's Success

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.

Commercial Approvals
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