Biotech Stocks Facing FDA Decision In January 2020

(RTTNews) - As another month comes to a close, it's time to take a look back at some of the regulatory news that made headlines in December.

The first generic versions of Novartis' Gilenya for the treatment of relapsing forms of multiple sclerosis in adults won the FDA nod on December 6, 2019. The companies that were granted approval for generic Gilenya were HEC Pharm, Biocon, and Sun Pharmaceutical Industries.

GSP Neonatal Creatine Kinase-MM kit, developed by PerkinElmer, received FDA approval on December 12, becoming the first test to aid in newborn screening for Duchenne Muscular Dystrophy.

After denying approval in August, the FDA, on December 12, granted accelerated approval to Sarepta Therapeutics' (SRPT) Vyondys 53, which is the first treatment for Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping. The Company has one more approved Duchenne muscular dystrophy treatment by the name Exondys 51, indicated for DMD patients with a confirmed mutation amenable to exon 51 skipping.

On December 13, Boston Scientific Corp.'s EXALT Model D Single-Use Duodenoscope was cleared for marketing in the U.S., becoming the first fully disposable duodenoscope. It is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems.

Although only 48 *novel drugs and biologics received FDA approval in 2019 compared to an all-time high of 59 in 2018, the number is still well above the FDA's 5-year annual average, which is 43 drugs per year. *Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

Now, let's take a look at the FDA calendar of January 2020.