Biotech Stocks Facing FDA Decision In May 2019

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A lot happened in the month of April, from the resignation of FDA Commissioner Scott Gottlieb coming into effect, approval of the first targeted therapy for metastatic bladder cancer, and market clearance of the first medical device for treatment of ADHD to the launch of the world's first malaria vaccine.

The resignation of Scott Gottlieb who served as the 23rd Commissioner of FDA came into effect on April 5, 2019. Curbing teen smoking and ending the opioid crisis were some of the subjects close to his heart. He has now joined the American Enterprise Institute to focus on drug pricing issues. Norman E. "Ned" Sharpless, took over charge as Acting Commissioner of the FDA on April 5, 2019.

The first targeted therapy for metastatic bladder cancer, Balversa, was granted accelerated approval by the FDA on April 12, 2019. Developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary, Balversa is indicated to treat bladder cancer that has a type of susceptible genetic alteration known as FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.

The first medical device to treat attention deficit hyperactivity disorder, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, was cleared by the FDA for marketing on April 19, 2019. Developed by NeuroSigma Inc., a Los Angeles based medical device company, this prescription-only device is indicated for patients of ages 7 to 12 years who are not currently taking prescription attention deficit hyperactivity disorder (ADHD) medication.

The first generic nasal spray version of Narcan to stop or reverse the effects of an opioid overdose secured FDA approval on April 19, 2019. Developed by Teva Pharma, this generic naloxone nasal spray is for use in a community setting by individuals without medical training. The regulatory agency is also taking new steps to support the development of over-the-counter and additional generics of naloxone to help reduce opioid overdose deaths and increase access to emergency treatment.

On April 23, 2019, the world's first malaria vaccine, named RTS,S, was launched in Malawi, a country in southeast Africa, as part of a pilot program. Developed by GlaxoSmithKline plc (GSK) in collaboration with PATH, a global health nonprofit organization, and with support of the Bill & Melinda Gates Foundation, this vaccine is prescribed for children up to 2 years of age, and will be rolled out in two more African countries, Ghana and Kenya, in the coming weeks.

As of this writing, 8 novel drugs have been greenlighted by the FDA for this year. Now, let's take a look at the companies that await a ruling from the FDA in May 2019.

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