Plus   Neg

Biotech Stocks Facing FDA Decision In August

pharma august 072518 lt

As another month comes to a close, it's time to take a look back at some of the biggest news stories of July on the pharma sector, and look ahead at what's coming next over the horizon on the regulatory front.

If you have been following the pharma press over the past few days, you would be familiar with the name Valsartan.

Valsartan is an active pharmaceutical ingredient in drugs used to treat high blood pressure and heart failure. On July 13, the FDA issued a recall of medicines containing Valsartan, supplied by one particular Chinese company, due to the presence of N-nitrosodimethylamine (NDMA), a substance that could cause cancer. More than 23 countries have recalled this drug due to potential carcinogen contamination.

There were also a couple of firsts that happened on the regulatory front in July.

-- SIGA Technologies Inc.'s (SIGA) Tpoxx was greenlighted by the FDA on July 13, becoming the first drug with an indication for treatment of smallpox.

-- Novartis' Kisqali approved on July 18 as a first-line treatment in combination with an aromatase inhibitor for premenopausal and perimenopausal women with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer is the first cancer drug to be approved through FDA's RTOR (Real-Time Oncology Review). The RTOR allows the regulatory agency to review much of the data earlier, before the applicant formally submits the complete application.

-- On July 20, Agios Pharmaceuticals Inc.'s (AGIO) Tibsovo won FDA approval, becoming the first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation.

Now, let's take a look at the biotech stocks that await FDA word next month (August).

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT