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Biotech Stocks Facing FDA Decision In March

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After a banner year in 2018, the novel drug approval is off to an uncharacteristically slow start this year. No novel drug was approved in January while three were approved in February.

As we head into March, it's time to take a look back at some of the regulatory news that made headlines in February.

On February 6, the FDA approved Ablynx's Cablivi, the first therapy for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura, a rare blood clotting disorder.

To ensure greater accountability in the nation's drug supply chain, on February 7, the FDA launched a Pilot Project Program Under the Drug Supply Chain Security Act (DSCSA Pilot Project Program). The DSCSA Pilot Project Program is intended to assist FDA and members of the pharmaceutical distribution supply chain in the development of the electronic, interoperable system that will identify and trace certain prescription drugs as they are distributed within the U.S.

Certain retail locations of Walgreen Co. and Circle K Stores Inc. are in the FDA's crosshairs for repeated violations of restrictions on the sale and distribution of tobacco products, including sales of cigars and menthol cigarettes to minors. On February 7, the U.S. regulatory agency filed complaints seeking No-Tobacco-Sale Orders (NTSO), which seek to bar the two specific retail locations from selling tobacco products for 30 days.

As part of its commitment to curb healthcare fraud, the FDA, on February 11, took action against 17 companies for illegally selling products claiming to treat Alzheimer's disease. More than 40 warning letters have been issued by the FDA in the past five years to companies illegally marketing over 80 products making Alzheimer's disease claims on websites, social media and in stores.

On February 14, Tandem Diabetes Care Inc.'s t:Slim X2 insulin pump was cleared by the FDA, becoming the first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices.

Now, let's take a look at the companies that await a ruling from the FDA in March 2019.

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