The agency has already approved 20 new medicines this year.

By Clifton Leaf and Sy Mukherjee
May 9, 2017

Good morning, readers. This is Sy.

The Food and Drug Administration (FDA) has been on a streak of late. Over the weekend, the agency approved the first new treatment for ALS, or Lou Gehrig’s disease, since 1995 (Mitsubishi Tanabe Pharma’s Radicava). The brings the total number of new medicine approvals up to 20 so far this year.

So how does that stack up against the FDA’s historical performance? Consider this: there were 22 new treatments cleared for the market in all of 2016.

To be fair, last year’s sluggish pace was a bit of an outlier compared to the near-record 2014 and 2015, when the FDA green lit 45 and 41 therapies, respectively. But this year’s specific approvals are striking for another reason: several of them are the first-ever drugs to be made available in the U.S. for certain diseases.

That includes: BioMarin’s Brineura for a specific form of the rare disorder Batten disease (and a treatment that, at a $700,000 annual list price, is one of the most expensive therapies in the world); Roche/Genentech’s Ocrevus, the first medicine cleared to treat more severe kinds of multiple sclerosis (MS); and Neurocrine Biosciences’ Ingrezza, the first drug for the neurological disorder tardive dyskinesia.

While many of these therapies are breakthroughs for patients who have very limited options, they also reflect a trend in drug development: an overwhelming focus on specialty cancer and rare disease drugs. Given the reality of opportunity costs, that might mean some other therapeutic spaces are getting short shrift.

Read on for the day’s news.

Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

DIGITAL HEALTH

Instagram is trying to help users with mental health issues. My colleague Laura Entis explores popular picture and video social media platform Instagram’s new campaign to assist people with mental health problems. The #HereForYou initiative strives to raise “awareness about mental health and the importance of finding support,” as Instagram chief executive Kevin Systrom said in a blog post. For instance, a user in distress could click on the various hashtags associated with the campaign and be directed to mental health resources. (Fortune)

OptiNose raises $37 million for its new kind of inhaler. Pennsylvania-based biopharma firm OptiNose has hauled in $37 million in a Series D funding round led by Fidelity. The company’s main tech is a very different sort of inhaler platform that takes advantage of how your nose and mouth interact—the nasal cavity blocks up when you’re breathing out—in order to push medications much higher into the nostrils. OptiNose CEO Peter Miller told Fortune in an interview last year that this is a more effective, less wasteful way of inhaling drugs, since drugs delivered by conventional inhalers often wind up in your stomach (in which case, why not just take a pill?). The company is aiming for an FDA green light to treat Chronic Rhinosinusitis.


INDICATIONS

Valeant shares spike on earnings report. Valeant finally caught a break. The embattled drug maker on Tuesday announced its first profit in six quarters during its first quarter 2017 earnings call, sending its stock soaring as much as 20% in morning trading. The company has been trying to reverse an epic slump driven by a number of pricing and distribution scandals, as well as allegations of botched accounting. CEO Joseph Papa has been concentrating on paying down debt and focusing on the firm’s eye care, skin care, and gut drug portfolios. (Fortune)

Sanofi joins the price hike limiting club. French pharma giant Sanofi is joining the slew of drug giants voluntarily limiting price hikes on its products. In fact, the company’s going a little further than others employing this tactic: it’s pledging to get price increases down below health care inflation (about 5.4% this year) other than for “exceptional circumstances.” Other companies have promised to keep hikes within the single digits. (Reuters)


THE BIG PICTURE

Medicare failed to investigate suspicious hospital infection reports. A new report from the Department of Health and Human Services’ Office of the Inspector General finds that Centers for Medicare and Medicaid officials didn’t investigate reports of suspicious infection patterns at nearly 100 hospitals. The IG’s office points out that this may suggest a concerning trend because hospitals may receive bonuses or be charged penalties depending on the number of patients who develop an infection at those medical providers. Therefore, they might have incentive to game the system when submitting reports to Medicare. (NPR)

Death by zip code. A study published in JAMA Internal Medicine highlights the massive health disparities between where Americans live. In fact, the counties with the very highest life expectancy have a 20-year life advantage over the counties with the lowest life expectancy. “Several counties in South and North Dakota (typically those with Native American reservations) had the lowest life expectancy, and counties along the lower half of the Mississippi and in eastern Kentucky and southwestern West Virginia also had very low life expectancy compared with the rest of the country,” wrote the study authors. “In contrast, counties in central Colorado had the highest life expectancies.” (Fortune)


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Meet Amazon’s Newest Home Automation Deviceby Leena Rao

Produced by Sy Mukherjee
@the_sy_guy
sayak.mukherjee@fortune.com

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