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Biotech Stocks Facing FDA Decision In January 2019


As 2018 fades, it's time to take a look at the drug candidates lined up at the FDA altar awaiting the federal agency's decision in January 2019.

Before we look ahead, here are some of the regulatory news that made headlines in December.

December 21st marked the approval of two novel drugs - Elzonris, the first treatment for blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood disease, and Ultomiris, a new treatment for adult patients with paroxysmal nocturnal hemoglobinuria (PNH), which is also a rare and life-threatening blood disease.

As of this writing, 59 new molecular entities, or NMEs, have been green lighted by the FDA so far this year, clearly outpacing the 53 new drugs approved in 1996, the highest ever.

Another notable regulatory development of the month was the passage of The Hemp Farming Act of 2018, which removes hemp from the Controlled Substances Act, meaning that it will no longer be an illegal substance under federal law. But that said, the FDA will continue to have authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.

Hemp refers to cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC).

Essure, a permanent form of birth control device developed by Bayer, will no longer be sold or distributed in the U.S. after December 31, 2018. Since its approval in 2002, the product's safety and effectiveness has been monitored by the FDA.

In February 2016, Bayer was asked to conduct a post-marketing study to better evaluate the safety profile of Essure, and in November of that year, was asked to add a boxed warning to the product. With 70% of Essure sales getting eroded since FDA's actions in 2016, Bayer in July of this year, announced its decision to halt the sales of the device in the U.S. by the end of 2018.

Now, let's take a look at the biotech stocks that await a ruling from the FDA in January 2019.

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