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The FDA Kept Up Its Drug Approval Streak In 2019

January 7, 2020, 11:53 PM UTC

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Good afternoon, readers.

I hope all of you had a wonderful holiday—and saw our note about the upcoming Brainstorm Health conference in 2020.

The Food and Drug Administration (FDA) has seemingly been on a mission these past few years to get as many drug approved as possible.

Don’t take it from me—look at the agency’s own records of new approvals in 2019. Through December 23 of 2019, the FDA cleared 48 new treatments for conditions ranging from cancer to muscular dystrophy to schizophrenia. There were 46 “novel” treatments (the kind that aren’t based on existing drugs) approved in 2017, which was a record at the time. In 2018, there was a high of 59 novel treatments. This is a pretty big spike compared to 2010, when just 21 new, novel drugs were approved.

We’ve written about most of these recent drug approvals—and some of the controversies surrounding them. The pace of FDA green lights presents an opportunity for the industry—and hope for patients—but also raises questions about how regulators should balance their responsibilities to the public at large and cold, hard science.

Read on for the day’s news.

Sy Mukherjee
sayak.mukherjee@fortune.com
@the_sy_guy

DIGITAL HEALTH

Pear Therapeutics wants to expand its digital health platform. Digital health upstart Pear Therapeutics is leaning in to the virtual reality space, according to the company, with a number of agreements with medical providers such as the Cincinnati Children’s Hospital Medical Center and Winterlight Labs. The deals include some flashy health tech—including a form of gamification for pain and anxiety. 

INDICATIONS

Merck's Keytruda faces a rare miss. Pharma giant Merck's Keytruda has been a stunning success in the cancer immunotherapy field—which makes it all the more surprising when it faces clinical setbacks. Merck stock fell more than 2.6% (not exactly chump change for a $230 billion market value company) on news that its superstar treatment couldn't match up to plain old chemotherapy for a certain form of lung cancer. While Keytruda has proven itself in other types of lung cancer, investors were hoping that Merck could expand the drug's reach further in a particularly lucrative market. (FiercePharma)

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