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Biotech Stocks Facing FDA Decision In July

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We are halfway through the year, and it's time to take a look back at some of the regulatory news that made headlines in June and look ahead to what lies in store for the biotech stocks at the FDA altar.

Epidiolex, the first marijuana-based drug, to treat two severe forms of epilepsy, developed by GW Pharmaceuticals (GWPH), received the FDA nod on June 25.

As part of addressing the current fragmented Federal oversight of food safety, the Trump administration on June 21, proposed to reorganize the Food Safety and Inspection Service and the FDA into a single agency within the U.S. Department of Agriculture called the Federal Food Safety Agency.

Following the reorganization, the FDA would be renamed the "Federal Drug Administration", which would focus on drugs, devices, biologics, tobacco, dietary supplements, and cosmetics. The proposed reform is expected to reduce duplication of inspection at some food processing facilities, improve outreach to consumers and industry, and achieve savings over time, while ensuring robust and coordinated food safety oversight. This was revealed in a document titled "Delivering Government Solutions in the 21st Century".

The first generic versions of Suboxone sublingual film for the treatment of opioid dependence were greenlighted by the FDA on June 14, paving way for improved access to these medicines for patients who are in need.

Chinese API maker Henan Lihua Pharmaceutical Co. Ltd. is in the news for all the wrong reasons. With the company failing to take corrective actions to address the deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), a Warning Letter was issued by the FDA on June 12.

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

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