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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.
The US FDA on 10 June authorized use of Illumina’s COVIDSeq next generation sequencing diagnostic test to detect the SARS-CoV-2 virus and figure out if it’s mutating. The agency has high hopes this first-of-its-kind test will give researchers a better picture in the ongoing global fight against the COVID-19 pandemic.
The company secured FDA approval for selpercatinib in RET-driven NSCLC and thyroid cancer, months ahead of the PDUFA date. Oncology president Anne White talked to Scrip about the launch.
While not recommending changes in US FDA approval standards, Harvard researchers urge more disclosure about what is known and not yet known about targeted medicines. A central repository of data should be created, they suggest, allowing drug makers, test makers and pathology labs to share real-world data after approval. The journal article considers existing data for Novartis and Roche's approved BRAF inhibitor therapies to illustrate gaps in understanding about precision medicines.
The MET inhibitor already pending US FDA approval had good results in patients with brain metastases. Spectrum’s TKI inhibitor poziotinib continues to be studied after Cohort 1 failure.
With a PDUFA date fast approaching, AstraZeneca has presented more data from the PROfound study, this time showing that Lynparza improved OS compared to hormonal therapies in men with advanced castration-resistant prostate cancer with BRCA1/2 or ATM mutations.
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.
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