Biotechnology latest updating news
In a draft guidance released last week, FDA explains that products intended to reduce mosquito populations should be considered pesticides.That means that, if finalized, the guidance routes future GE mosquito strains to EPA for review.Celgene shares have rallied 3 percent year-to-date through Wednesday compared to the S&P 500's 14 percent gain.Makers of genetically engineered (GE) products have long been on the lookout for changes in U. And a set of new proposals released last week offers hints about what those agencies still hope to change.That FDA office oversees technologies for sterilizing and controlling animal populations, but giving it responsibility for gauging the environmental impact of a mosquito raised eyebrows on both sides of the debate.“Without relevant expertise, not surprisingly the FDA has been ill-equipped to review the application expeditiously,” wrote attorney John Cohrssen and physician and former FDA official Henry Miller in a op-ed last January.The company created a strain of —the mosquito species that transmits the Zika and chikungunya viruses—designed to spread a lethal gene and dramatically cut down populations.
USDA aims in its proposal to move away from regulating GE plants based on the process that produced them, and instead to evaluate the product itself for risk as a plant pest or noxious weed.
The percentage drop in the shares is the largest in 17 years.
"In consideration of certain market dynamics and recent pipeline events, we are updating our 2020 outlook, and remain confident in our ability to deliver industry leading growth," Celgene CEO Mark Alles said in a company press release Thursday.
(Designer mosquitoes intended to reduce disease transmission, such as those that spread the insect parasite , would still be considered “new animal drugs,” and would fall to FDA.) Oxitec now plans to seek approval for a new release site after residents in the Florida community of Key Haven voted against the proposed release last fall.
FDA could still be the one to make that determination before the new guidance is finalized, says Jack Bobo, chief of communications at Intrexon in Washington, D. It’s not yet clear how the EPA requirements would differ from those of FDA, he says.