The Food and Drug Administration (FDA) made a groundbreaking policy change last year that is having a large impact on the biotech industry and creating a big opportunity for investors. To create a faster path to commercialization for potentially life-saving drugs and medicine, the FDA in July introduced a new “breakthrough” status for drugs that show “substantial improvement on existing therapies for clinically significant endpoints.”#-ad_banner-# For an industry that is accustomed to a costly 10-year commercialization process, the breakthrough status is a welcome shift. An accelerated channel to… Read More
The Food and Drug Administration (FDA) made a groundbreaking policy change last year that is having a large impact on the biotech industry and creating a big opportunity for investors. To create a faster path to commercialization for potentially life-saving drugs and medicine, the FDA in July introduced a new “breakthrough” status for drugs that show “substantial improvement on existing therapies for clinically significant endpoints.”#-ad_banner-# For an industry that is accustomed to a costly 10-year commercialization process, the breakthrough status is a welcome shift. An accelerated channel to commercialization could enable drug companies to shave years and billions of dollars from the cumbersome process. But the FDA’s new breakthrough status isn’t just a win for drug companies and the health care industry — it’s also creating an opportunity to invest in the most innovative companies in the world. The companies winning breakthrough status for their drugs are in the hunt for the next billion-dollar blockbuster, something that can send both earnings and shares soaring. And now, just six months… Read More