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Biotech Stocks Facing FDA Decision In November


Looks like 2017 may be another banner year for novel drug approvals. So far this year, 34 novel drugs have been approved, and that is only 12 short of beating the record of 2015, which marked a 19-year high in terms of first-time drug approvals in the United States.

Here's a look back at some of the regulatory news that made headlines in October.

On October 18, 2017, the FDA approved the second CAR-T therapy, Yescarta. Developed by Gilead's (GILD) subsidiary Kite, Yescarta is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Novartis' (NVS) Kymriah, approved, in August, for the treatment of relapsed B-cell precursor acute lymphoblastic leukemia, is the first ever CAR-T therapy to win a regulatory green light.

Also of note are the FDA panel endorsement of Spark Therapeutics' (ONCE) Luxturna, on October 13th, for a form of childhood blindness, which if approved, would be the first gene therapy for a genetic disease in the U.S., and the FDA approval of Roche Molecular Systems' Cobas Zika test, the first test for screening Zika virus in blood donations, on October 6, 2017.

But that's not all!

Another big announcement related to public health is President Trump declaring opioid crisis a national public health emergency. According to the CDC, 91 Americans die every day from an opioid overdose. This official declaration, made on on October 26, 2017, is believed to go a long way in creating more attention and awareness about the opioid crisis.

Now, let's take a look at some of the biotech stocks that await a ruling from the FDA or FDA panel in November.

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