Ver­i­ly joins up with Duke, Stan­ford to en­list an army of con­sumers to put its next-gen sen­sor tech to the test — and in the pub­lic eye

Ver­i­ly Study Watch via Ver­i­ly

What can a new gen­er­a­tion of wear­able tech and biosen­sors teach us about dis­ease?

Ver­i­ly, for­mer­ly Google Life Sci­ences, is de­vel­op­ing and mar­ket­ing this tech. And it’s putting the com­pa­ny right at the cross­roads be­tween the bio­phar­ma in­dus­try and the pub­lic.

With con­sid­er­able fan­fare it’s an­nounc­ing a new pro­gram with Duke Uni­ver­si­ty and Stan­ford to re­cruit 10,000 par­tic­i­pants in a study to an­swer that ques­tion — us­ing this new tech to gath­er da­ta to pro­vide a base­line of in­for­ma­tion on healthy sub­jects and how they tran­si­tion to a dis­ease.

Each of the par­tic­i­pants will have their genome se­quenced and then tracked for at least four years, with their health da­ta col­lect­ed and stored in the Google cloud (nat­u­ral­ly).

Andy Con­rad, Ver­i­ly

So what does this mean to bio­phar­ma? Po­ten­tial­ly, quite a lot is at stake here af­ter Ver­i­ly has struck up deals with a num­ber of ma­jor phar­mas on dis­ease man­age­ment.

There’s a re­cent ven­ture formed with Sanofi — On­duo — to use mi­cro­elec­tron­ics to man­age di­a­betes, a core dis­ease fo­cus for the French phar­ma gi­ant. Glax­o­SmithK­line jumped in­to a $713 mil­lion joint ven­ture with Ver­i­ly to cre­ate new nan­otech-based bio­elec­tron­ic ther­a­peu­tics in a start­up called Gal­vani Bio­elec­tron­ics. And oth­ers have been in dis­cus­sions on how Ver­i­ly’s wear­able tech can track the course of a dis­ease like, say schiz­o­phre­nia, to help map a ther­a­peu­tic reg­i­men for pa­tients.

In this new pop­u­la­tion health project, in­ves­ti­ga­tors plan to gath­er in­for­ma­tion on bio­mark­ers linked to dis­ease de­vel­op­ment, all prime tar­gets for new drug de­vel­op­ment. And they’ll be us­ing Ver­i­ly’s new “Study Watch,” un­veiled a few days ago and re­viewed by An­to­nio Re­gal­a­do at MIT Tech­nol­o­gy Re­view, which in­cludes an elec­tro­car­dio­gram to study heart rhythms.

This new project not on­ly show­cas­es the tech­nol­o­gy Ver­i­ly is sell­ing to a world of con­sumers avid­ly in­ter­est­ed in mon­i­tor­ing their health. It can pro­vide in­sights on pa­tients in clin­i­cal tri­als and help di­rect re­searchers to new ther­a­pies in emerg­ing fields like the mi­cro­bio­me.

Ver­i­ly is do­ing this with a more prac­ti­cal ap­proach to health man­age­ment. In­stead of talk­ing about moon shots, Ver­i­ly’s chief — the col­or­ful Andy Con­rad — is fo­cused on tak­ing one care­ful step at a time to­ward a big new mar­ket.

Now it’s all about “set­ting the goal and then get­ting down to the day-to-day prac­ti­cal drudgery,” Con­rad told Bloomberg. “If you ex­am­ine the re­al moon­shot close­ly, you’ll see a dude whose job is to riv­et and a la­dy whose job is to do some wiring.”

They’re just do­ing it in a way sure to at­tract the at­ten­tion of every me­dia op­er­a­tion in the coun­try.

Ver­i­ly is al­ready deeply en­gaged with the in­dus­try on pol­li­nat­ing R&D and drug use with its tech­nol­o­gy. Now they want to get the pub­lic’s at­ten­tion. Ear­ly re­views would sug­gest that they’re off to a strong start.

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.