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Monthly Archives: March 2012
Dealing with Rejection, the Regulatory Kind
The ubiquitous CRL in biotech has made its way into the news headlines again. But is the Complete Response Letter a game-changing hurdle for a biotech, or is it par for the course these days? It turns out that almost half of NDA/BLA filings get rejected by the FDA on the 1st round. However, most companies resubmit their application, and by the 2nd review 75% of drugs gain FDA approval. After heading for a 3rd Read More >
Synthetic Biology Survey Requires Industry Response
The Woodrow Wilson Synthetic Biology Project has released a public survey soliciting opinions on synthetic biology. It is a follow up to a recent paper on synthetic biology released in Nature, and it is filled with biased questions that revive some of the oldest misconceptions about the biotechnology industry. The results of the survey are expected to be released in May 2012. BIO is encouraging members of the industry to participate in the survey and Read More >
Building a Better Cherry Blossom
The March 22 edition of the Huffington Post features a USDA video about DC’s famous cherry trees and what’s being done to improve them. The video features United States Department of Agriculture research geneticist Margaret Pooler, who says that scientists are now looking for ways to make cherry trees hardier – including breeding and developing trees that are disease resistant and that are well-suited for city environments. The brief video explains the origin of DC’s Read More >
2012 Biotech Humanitarian Award Nominations Open
BIO is now accepting nominations for the fourth annual Biotech Humanitarian Award. The Award will be given to an individual who, through their work in or support of biotechnology, is harnessing its potential to heal, fuel or feed the planet. The Humanitarian Award honors work that aims to reduce human suffering significantly or enhance the human experience in a way that has a clear and direct benefit to society. Additional consideration will be given to Read More >
As Vaccine Exemptions Rise, Risk of Outbreaks Intensifies
Generally, we think of vaccines as protecting the vaccinated. We often forget that vaccines, when administered to enough people, protect those in the community who cannot be vaccinated due to certain health conditions, who are too young to be vaccinated, or who experience vaccine failure. This “herd immunity,” as it’s called, is analogous to the concept of ‘safety in numbers’ and is critical to outbreak prevention. However, as reported by Valerie Bauerlein and Betsy McKay Read More >
