The FDA Went on an Epic Drug Approval Binge This Week: Brainstorm Health
Happy Friday, readers!
The Food and Drug Administration (FDA) isn't resting on its laurels in the dog days of summer.
In the past week, the FDA has approved five novel new drugs to treat a slew of conditions from cancer to the skin disease psoriasis to tuberculosis (TB) to the sleep disorder narcolepsy. Two of the approvals were granted Wednesday; another one on Thursday; and then two more on Friday.
Here's what they were, in chronological order: Pretomanid, a medicine for the most drug-resistant forms of TB that was created by the nonprofit TB Alliance and will be distributed by Mylan; Wakix, a new therapy from private firm Harmony Biosciences to treat excessive daytime sleepiness in narcolepsy patients (and reportedly the first drug of its kind to not be classified as a controlled substance by the DEA); Roche's Rozlytrek, a personalized cancer treatment that is specific to genetics rather than a specific kind of tumor or cancer; Celgene's Inrebic, a so-called "JAK inhibitor" approved for the bone marrow cancer myelofibrosis (and whose green light is a boon to drug giant Bristol-Myers Squibb, which is buying Celgene); and, finally, Rinvoq, a rheumatoid arthritis drug from biotech giant AbbVie which the company hopes will staunch bleeding sales of its nearly two-decade-old superstar Humira, which is still the world's best-selling drug. AbbVie is currently in the process of buying Botox maker Allergan in its own mega-deal.
It should be noted that the latter two treatments from Celgene and AbbVie are part of a class that come with some notable adverse events and black box warnings. Still, they could prove an improvement to certain patients.
All told, the FDA has now approved 23 new treatments to date this year. And this is now a multi-year trend with the agency, which appears eager to get as many new treatments (branded, generic, or otherwise) onto the market as soon as possible. (How efficacious and cost-effective those treatments are, of course, is a more complicated discussion.)
Read on for the day's news, and have a wonderful weekend.
Gates Foundation picks up an Apple digital health vet. The Bill & Melinda Gates Foundation has snatched up Dr. Andrew Trister, a veteran of Apple’s burgeoning digital health department, in order to help fund digital health startups and ventures aiming for a global impact. The Foundation has consistently shown an interest in using technology to mitigate community health issues in isolated and troubled regions. (pharmaphorum)
The company formerly known as Valeant is still hiking prices. “Valeant Pharmaceuticals” is now technically known as “Bausch Healthcare.” But it appears that some habits die hard. A Wells Fargo analyst, in a new research note, writes that Bausch is still relying on price hikes to plug holes in its revenue stream and make up for a lackluster pipeline. Valeant became a punching bag for presidential candidates in the 2016 election. (FiercePharma)
THE BIG PICTURE
Obamacare replacement is a flat circle. Ok, I’m sorry for the now-dated pop culture reference. But here we are again. The Trump administration says that it’s actively working on a new Obamacare replacement plan should courts strike down the entirety of the law as part of a suit being supported by the administration (and also, apparently, just in general since Congressional Republicans have failed to coalesce around any specific Affordable Care Act alternative for nearly 10 years). Like many previous efforts along these lines, there isn’t a set timeline for when the plan will be released, and ACA repeal at the Congressional level is D.O.A anyways with the House being controlled by Democrats. (The Hill)
Google’s Hate Speech Detection A.I. Has a Racial Bias Problem, by Jonathan Vanian
Commentary: Regulate Fintechs for What They Do, Not What They Don’t, by Kathryn Petralia
The Weirdness of WeWork’s IPO Filing, by Alan Murray
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