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Biotech Stocks Facing FDA Decision In August 2019

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After having had a banner year for new drug approvals in 2018, hitting a record number of 59, it looks like the pace of FDA approval is slowing down this year. Only 16 new drugs have been greenlighted so far this year compared to 26 during the same period last year.

On July 24, 2019, the FDA approved the glucagon nasal powder Baqsimi from Eli Lilly (LLY) for patients with severe hypoglycemia. Baqsim is the first needle-free treatment for severe hypoglycemia to be given the regulatory nod.

Some of the newsworthy stories of July on the regulatory front that merit mention are the approval of the first Lyrica generics, and the FDA taking significant action to protect women from breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

On July 19, 2019, the FDA approved multiple applications for first generics of Pfizer's Lyrica for the management of neuropathic pain.

The FDA granted approvals for the generic versions of Lyrica to Alembic Pharma, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy's Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals. Lyrica lost patent protection in June of this year. The drug, which is Pfizer's second bestseller, recorded sales of $4.6 billion in 2018.

On July 24, 2019, the FDA requested Allergan to recall specific models of its textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma. As of July 6, 2019, a total of 573 cases of breast implant-associated anaplastic large cell lymphoma and 33 patient deaths due to that cancer have been reported worldwide.

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

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