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Biotech Stocks Facing FDA Decision In March 2020

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A medical hot topic that been making headlines this year is the coronavirus outbreak. As per the latest World Health Organization report, 53 countries have been impacted by the new coronavirus COVID-19, with 85,403 confirmed cases globally - a vast majority of them being in China. The number of deaths due to the coronavirus is 2,838 in China and 86 outside of China.

The first coronavirus-related death in the U.S. was confirmed on February 29, 2020, from the state of Washington.

A number of companies have jumped onto the "Coronavirus bandwagon", and Gilead Sciences leads the pack to find a drug for this killer disease. The Company's investigational antiviral drug Remdesivir is under phase III studies in China and in the U.S. Results from two phase III trials in China are expected in April.

There is no treatment or vaccine yet for COVID-19.

Besides coronavirus, here are some of the other stories that made front-page news, particularly on the regulatory front, in the month of February.

Asuragen Inc.'s AmplideX Fragile X Dx and Carrier Screen Kit received FDA clearance on February 21, becoming the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability.

The first generic of ProAir HFA Inhalation Aerosol, developed by Perrigo Pharmaceutical Co. for one of the most commonly used rescue inhalers in the U.S., received the FDA nod in February 24, 2020. It is intended for the treatment or prevention of bronchospasm in patients four years of age and older with reversible obstructive airway disease and the prevention of exercise-induced bronchospasm in patients four years of age and older.

The FDA approved 5 novel drugs in February, bringing the tally of the Novel Drug Approvals so far this year to 8.

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

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