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Biotech Stocks Facing FDA Decision In January 2018


2017 has proven to be the second best year ever in terms of novel drug approvals, with 46 getting greenlighted by the FDA. Earlier, 1996 was a record year when 53 novel drugs were approved.

Between 1997 and 2013, an average of 27 novel drugs were approved per year. Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

The number of novel drugs approved was 41 in 2014, and 45 in 2015. Last year, only 22 new medicines received the official stamp of approval, the worst since 2010.

Before we take a look at the stocks awaiting FDA decision in January 2018, here's a bit of what happened this month.

On December 11, 2017, Sanofi's (SNY) Admelog became the first short-acting insulin to be approved as a "follow-on" product, i.e., to be approved using the FDA's 505(b)(2) pathway.

GlaxoSmithKline's (GSK) Nucala became the first FDA-approved therapy specifically to treat Eosinophilic Granulomatosis with Polyangiitis, a rare disease, formerly known as the Churg-Strauss Syndrome, when it was given a green light by the FDA on December 12, 2017.

On December 19, 2017, the FDA approved Spark Therapeutics Inc.'s (ONCE) Luxturna, a novel gene therapy, to treat patients with a rare form of inherited vision loss. Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations in a specific gene.

La Jolla Pharmaceutical Co.'s (LJPC) Giapreza to increase blood pressure in adults with septic or other distributive shock received thumbs up from the FDA on December 21, 2017, which marked the 46th novel drug approval of the year.

Now, here's the list of biotech stocks that await a ruling from the FDA in January 2018.

by RTT Staff Writer

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