Biotech Stocks Facing FDA Decision In April

Although nothing much happened in terms of approvals, March was a fairly busy month for the FDA on a number of fronts.

Here is a summary of what made news, as we wrap up another month.

In order to ensure that food labels contain updated nutritional information AND to help people make more informed food choices, the FDA, on March 1, 2018, issued practical guidance to food manufacturers and consumers related to the new version of the Nutrition Facts label.

Delivering a speech at America’s Health Insurance Plans’ (AHIP) National Health Policy Conference, on March 7, 2018, FDA Commissioner Scott Gottlieb announced the endeavors that are being taken to support the development of follow-on biologics, known as biosimilars and interchangeables.

In a bid to reduce or eliminate the addictiveness of cigarettes, the FDA, on March 15, 2018, issued an advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a product standard to lower nicotine in cigarettes.

Taking a closer look at flavors in tobacco products, another ANPRM was issued by the FDA on March 20, 2018. The regulatory agency is seeking public inputs for examining the role that flavors – including menthol – play in initiation, use and cessation of tobacco products among youth and adults.

In a first, the FDA posted a Clinical Study Report on its site on March 19, 2018, aiming for more transparency about New Drug Approvals. The first published report is about Janssen Biotech’s Erleada, the first FDA-approved treatment for non-metastatic, castration-resistant prostate cancer, which received the regulatory nod on February 14, 2018.

In March, the FDA approved two novel drugs. Trogarzo, a new HIV treatment for patients who have limited treatment options, was approved on March 6, 2018, and Ilumya, for the treatment of adults with moderate-to-severe plaque psoriasis, was approved on March 21, 2018.

As of this writing, only 6 novel drugs have been greenlighted so far this year, compared to 12 last year.

Now, let’s take a look at the biotech stocks that await a ruling from the FDA in April 2018.

by RTTNews Staff Writer

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