Archive by category | Regulatory

Made in Chile

Made in Chile

Chile has this bad habit of being in the news solely for terrible reasons. Take September 2015: an 8.4 earthquake hits the country and is followed by around a thousand aftershocks. But among the pictures of fallen houses and coastal damages and the half-sad, half-numb resignation that proceeds them there was good news: the apparition of an innocuous and universal cancer drug, made in Chile. This is the promise of Andes Biotechnologies, a Chilean biotech company whose invention has just been cleared by the FDA for clinical trials in the US.  Read more

Driving Lessons

Driving Lessons

Gene drives have spurred controversy of late. In the October issue of Nature Biotechnology, we hear the perspective of several researchers who have been developing gene drive technology, in some cases for decades. Their perspective has been seemingly missing from the extensive reporting that followed publication of a CRISPR-Cas9 mediated gene drive in Drosophila in April 2015, and much of the debate has focused on the potential hazards of the technology. We talked to them and to researchers raising alarm bells about the technology to explore just how likely the doomsday scenarios are.  Read more

Out of Step

Out of Step

In our current issue of Nature Biotechnology, Randy Osborne presents an overview of some of the most notable drug approvals in 2012 in our annual feature, Fresh from the Biotech Pipeline. Although 2012 was a bumper year for drug approvals, the types of treatment approved suggest commercial developers are insufficiently incentivized to develop products addressing major health needs.  Read more