Cautious welcome for FDA pharmacogenomics guidance

  title={Cautious welcome for FDA pharmacogenomics guidance},
  author={Alla Katsnelson},
  journal={Nature Biotechnology},
Strong political signal in favor of personalized medicines. 

Industry strategies on theranostics : Need for structural alignment

It is put forward that, for structurally taking up theranostics, there is limited structural alignment between (bio-pharmaceutical companies, and specialised firms in diagnostics and pharmacogenomics companies.

1.05 – Personalized Medicine

Functional genomics identifies ABCC3 as a mediator of taxane resistance in HER2-amplified breast cancer.

A functional genomics approach using a well-characterized panel of breast cancer cell lines to identify putative biomarkers of resistance to antimitotic agents such as paclitaxel and monomethyl-auristatin-E (MMAE) shows that amplification of ABCC3 is present in primary breast tumors and that it occurs predominantly in HER2-amplified and luminal tumors.

Prospective positioning of industrial players: the case of theranostics

By studying annual reports, this work gains insight into how industries react strategically towards emerging technological fields and makes a contribution to positioning theory itself.



FDA and EMEA pool scientific advice

Biotech companies could have their say in setting up standards for regulatory approval of cutting edge drugs, as they benefit from parallel scientific advice from Europe and the US.