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Biotech Stocks Facing FDA Decision In July


June was certainly a busy month for the FDA. Barring H. Lundbeck's Trintellix sNDA, Coherus' CHS-1701 and Pfizer's Epogen biosimilar, which were issued a Complete Response Letter, all the other drug candidates that were at the FDA altar in June scored the regulatory agency's stamp of approval.

Of the approved drugs in June, two were novel drugs - Melinta Therapeutics' Baxdela for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults, and Portola Pharma's BevyxXa for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness.

Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before.

So far this year, 23 novel drugs have already received FDA approval. This number stacks up well against last year's tally because for the whole of 2016, only 22 novel drugs were approved.

On a more official front, the FDA, on June 27, 2017, announced two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost generics. Under the new Drug Competition Action Plan, the regulatory agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited.

Now, let's take a look at the biotech stocks waiting to hear from the FDA in July.

by RTTNews Staff Writer

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