Legal Research

This Week?s Biotech Highlights

By Jeremy Grushcow

This week saw a series of new ideas in the world of biotech, ranging from regulatory irregularities to corporate suicide by securities. 

Health Canada kicked off the week with a novel thought: caffeine guidelines for 4-year-olds.  To be fair, it was in the context of expanding the types of soft drinks that can have added caffeine; so I suppose that some 4-year-olds who have been guzzling 7-UP might have to moderate their intake (or at least watch the label).  The guidelines for adults are (I hope) more relevant and are worth reviewing.

The FDA had a new idea too: scolding drug developers for deficient applications.  In one instance this week, the agency’s oncology panel called Australian cancer drug developer ChemGenex out for ?fairly sloppy drug development.? It was an instructive moment for personalized medicine, as well as for ChemGenex, because it emphasized that the FDA is very concerned about the accuracy of the diagnoses underlying treatment decisions.

Capstone Therapeutics’ new idea was to give its shareholders direct control over a key corporate decision — if its clinical trials failed, should the company dissolve, returning funds to shareholders, or try to rebuild value through other products or strategies?  It created a new shareholders’ right that could be implemented next month’s annual meeting, more than a year in advance of finding out the trial results.

Only the Ontario government found itself without new ideas this week. The 2010 Budget provided a funding boost for the Ministry of Research and Innovation, but needed program changes are still pending.

Stay tuned to The Cross-Border Biotech Blog to see what Ontario cooks up, or check out @crossborderbio for speedy, if unleavened, updates.

Full post as published by Slaw.ca on March 29, 2010 (boomark / email).