Welcome back. Last week in E&O Fridays, I wrote about Akili’s pricing for EndeavorRx, Apple’s latest FDA clearance, and a number of notable digital-related clinical trials.

 E&O Fridays.

The calendar shows that this edition will be the last E&O Fridays newsletter of 2020. Next Friday is Christmas day and the following Friday is New Year’s Day, so this one will pick up again on January 8th.

In the meantime, I’ll publish on Monday and Wednesday next week. I’ll also have the UnitedHealth Group report out during the last week of December, so expect an email about that around then.

Finally, I’m collaborating with my friends at HealthXL on a year-end report focused on Prescription Digital Therapeutics. That will be out early in the New Year, and all E&O subscribers will have access to it.

But first, here’s what’s happening this week in the world of digital pharma products and FDA-regulated digital health:

• Ronny Hashmonay, who for the past three years has served as VP, Head of Innovation and Head of Digital, Launch Excellence & BD&L at Novartis Pharmaceuticals US, was just promoted to Chief Digital Officer of Novartis Pharma US. (Bertrand Bodson remains as Chief Digital Officer of the global parent company.)
• Speaking of notable hires and promotions, digital therapeutics company Amalgam officially announced that Chris Bergstrom had joined as President. (E&O reported on that seven months ago back in Issue 050.) Amalgam also added Sonny Vu to its board. Vu previously founded and ran diabetes device maker and digital medical device pioneer, Agamatrix, before starting up Misfit Wearables, which he sold to Fossil.
• Elektra Labs hired Pfizer’s former Head of Data Science, Shyamal Patel. Elektra also acquired an asset from Scripps Research Translational Institute: its Digital Health Library. Elektra will fold that into Atlas, its searchable product catalog of remote monitoring technologies.
• FDA’s digital health leads penned an article in Nature’s Digital Medicine journal that included a quick redux of what they hope to learn about digital health during the pandemic. Not a lot of new insights here, but they do mention maybe tweaking risk profiles and frameworks in Pre-Cert based on the experiences of patients and providers during the pandemic.
• Renalis, which is building a prescription digital therapeutic for overactive bladder, acquired Vesica, makers of a bladder diary app.
• Missed this last week: A long list of digital health companies and pharmacos (along with Amazon) launched The Decentralized Trials & Research Alliance (DTRA). More here.
• I’ll get into these a bit more in Monday’s issue, but a few funding rounds of note in recent days: DTx startup S-Alpha raised $2.7 million. French DTx co Lucine raised $6.6 million. And Verily announced a new $700 million injection.
• And if like me, you’ve been anxiously waiting to read the special controls that went along with Mahana Therapeutics’ De Novo clearance for its IBS DTx, Parallel, you’re in luck: The FDA posted the reclassification letter here.
• One more thing… This is more medtech than pharmatech, but two notable changes in the world of wearable cardiac monitoring. iRhythm’s getting a new CEO and Philips just bought BioTelemetry (nee CardioNet) for $2.8 billion.

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Moderna, FriendsLearn and the legal carve-up over who owns the term “digital vaccine”

A few weeks back I predicted that digital therapeutics will eventually split into three groups: prescription digital therapeutics that use software to treat diseases; digital-enabled programs that help people manage their chronic conditions; and digital-enabled programs that prevent medical issues. That last category is sometimes called “digital vaccines”.

I’m not a huge fan of this term, but it took me a long while to come around to “digital therapeutic” too.

Regardless, the rights to use the term “digital vaccine” went through a multi-year legal battle that settled up in June 2019. While this court case, initially generated some headlines in India, which is where one of the companies involved in the case is based, when the case settled the decision came out with little to no fanfare.

This all started when ModernaTx, the now-famous biotech company (it is working on a vaccine for COVID–19) filed to trademark “digital vaccine” in 2016. The USPTO rejected it on the grounds that FriendsLearn had already used the term and gotten it published in medical journals. (FriendsLearn’s research partners include big names in academia like Carnegie Mellon, Johns Hopkins Bloomberg School of Public Health, Stanford School of Medicine, Pittsburgh Children’s Hospital of UPMC, and Duke School of Medicine.)

FriendsLearn has developed a gamified digital health program, called fooya, that it refers to as a digital vaccine for obesity.

Moderna, of course, was using the term in an entirely different way. The biotech firm wanted to use the term “digital vaccine” as a general way to describe whichever messenger RNA-based vaccines it ended up creating. The digital component, as I (don’t really) understand it, was more about the development process and not the delivery method.

To make a long story shorter, the court case ended with Moderna agreeing to coexist with FriendsLearn. The digital health company could use the term (but not trademark it) so long as it made clear its “digital vaccine” didn’t include any pharmaceutical components.

And Moderna had to tack on an explanatory clause to its original filing that made clear its vaccines were “biotherapeutics consisting of bioengineered medicines that are physically administered into the human body.”

You know, unlike vaccines that aren’t physically administered into the human body. In any case, that settlement likely marked the first historic win for the digital vaccine cause.

Two new prescription digital therapeutics secure reimbursement in Germany via DiGA

As of this writing, there are now nine prescription digital therapeutics in the German government’s DiGA database.

(If you’d rather read about them in English and have the ability to search them — check out the E&O mini-database that’s tracking them here.)

This week’s additions include a DTx for migraines, called M-sense Migraine, which was developed by Newsenselab. (I actually mentioned them last week when they announced their inclusion, but I held off adding them to the E&O database since DiGA hadn’t added them officially yet.)

The other new addition is a DTx called elevida that GAIA developed. Elevida helps treat fatigue in people with multiple sclerosis.

This marks the second DTx from GAIA to find its way into the Germany digital health formulary. So, GAIA is now the only company that holds the distinction of having two products listed.

GAIA also now holds the distinction of offering the most expensive DTx in the German formulary. Elevida’s price tag is $910 for three months of treatment. The next most expensive DTx in the formulary is aidhere’s obesity-focused DTx, zanadio, which runs about $610 for three months.

Apple-Janssen pushback Heartline study completion to 2024. Amgen-Biobeat push too.

This week Apple and Janssen changed their timeline for the final end date of their high-profile Heartline study, which as the title explains is “A Heart Health Study Using Digital Technology to Investigate if Early AF Diagnosis Reduces the Risk of Thromboembolic Events Like Stroke IN the Real-world Environment”.

Originally, the study was set to be finished in December 2023, but the companies changed their study record in Clinical Trials DOT gov to show a new anticipated study completion date of April 2024. (That seems so far away.)

Another digital health trial that Amgen and Biobeat are conducting pushed its anticipated end date from September 2021 to February 2022. Biobeat has developed a wristwatch that monitors blood pressure. The study is called “A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy.”

Biobeat is also conducting a study in Israel called a “Comparison of Continuous Non-Invasive Blood Pressure Measurement Using the Wireless Cuffless Biobeat Monitor With an Invasive Arterial Line Catheter” that includes patients coming out of heart surgery. That study also had its expected end date pushed from now — December 2020 — to August 2021.

E&O research reports, databases, newsletters

After a few, simple design tweaks, The Exits & Outcomes site is now better organized to make it easier to find long-form research reports, databases, and past newsletter editions. Click below for dedicated pages for each of those categories:

Read through the long-form E&O research reports here.

Search and sort the E&O databases here.

Skim more than 90 past issues of E&O newsletters here.

Let’s call that Issue 082 of E&O Fridays.