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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.
Draft guidance will help sponsor-investigators working on individualized gene therapies. The focus on basic administrative and procedural aspects of interaction with the FDA leaves many policy and commercialization questions about how these personalized investigational products should be studied unanswered.
Telehealth and data from devices such as continuous glucose monitors will play an increasingly important role in helping clinicians spot disease early, Glooko Chief Operating Officer Komathi Stem said during a recent panel discussion on metabesity.
An expert panel recently discussed the complex issues surrounding metabesity. See what panelist Tomas Landh, vice president of innovation sourcing, Novo Nordisk said about it here.
Metabesity is a complex issue that will require a multi-disciplinary approach, concerted effort and clear regulatory pathway to achieve solutions.
The pending US FDA decision on Biogen’s drug overshadows progress in Alzheimer’s diagnosis, symptomatic treatments and the need to keep studying anti-tau therapies after Roche’s setback.
The company has assembled small molecule discovery capabilities for the development of targeted cancer drugs that it believes rivals big pharma efforts and will fulfill patients’ unmet needs.
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