Biotech Stocks Facing FDA Decision In August 2020

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As another month comes to a close, it's time to take a look back at some of the top news stories of July related to FDA approvals and look ahead at what's coming next over the horizon.

Rukobia, a novel attachment inhibitor developed by GlaxoSmithKline's ViiV Healthcare, was approved in the U.S. on July 2, for adults living with HIV who have tried multiple HIV medications.

A new therapy for the treatment of adult patients with myelodysplastic syndromes, Otsuka Pharma's Inqovi, received the regulatory nod on July 7, representing an important advance in treatment options for patients with this type of blood cancer, who previously needed to visit a health care facility to receive intravenous therapy.

The field of gene therapy has been experiencing rapid development ever since the world's first gene therapy, Gendicine, was approved in China in 2003 for head and neck squamous cell carcinoma. In the U.S., Novartis' (NVS) Kymriah, the first gene therapy, won the regulatory nod in 2017. It is indicated for acute lymphoblastic leukemia, and large B-cell lymphoma. Gilead's Tecartus, the first cell-based gene therapy for adults with relapsed or refractory mantle cell lymphoma, was approved by the FDA on July 24.

As of this writing, so far this year, 29 novel drugs have won the FDA stamp of approval - with 4 in the month of July. This compares to 17 and 4, respectively for the same periods in 2019.

Now, let's take a look at the companies that await a ruling from the FDA next month.

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