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Stock Watch: Class Of 2016 FDA Approvals

Seller Beware: Ignore Your Market At Your Peril

 
• By Andy Smith

Revenues are still elusive for a surprising number of the novel drugs approved by the FDA five years ago. Emergent safety issues and confirmatory clinical trial failures were less common than lack of competitiveness as the main reason for revenue weakness.

Stock Watch Image, Andy Smith
ANDY SMITH OFFERS A LIFE SCIENCE INVESTOR'S PERSPECTIVE ON BIOPHARMA BUSINESS

In 2017, while working in a drug pricing and commercialization consultancy, I prepared a slide analyzing the 2016 sales of the 35 novel drugs that were approved in 2011. I have just repeated the exercise for the drugs approved in 2016. Five years may not always be enough to reach blockbuster status, but among the 22 drugs that were approved by the US FDA in 2016, five blockbusters had stretched away from eight with undisclosed or absent sales by 2020. And then there were those in between.

To demonstrate to smaller biotechnology companies the importance of conducting market research with payers, the slide I constructed in 2017 showed that 19% of drugs approved by the US FDA...

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• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

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