Ap­ple de­vices, in tan­dem with dig­i­tal apps, could de­tect ear­ly signs of Alzheimer's, de­men­tia: study

Ap­ple has long sunk its talons in­to the health care in­dus­try, hav­ing forged re­la­tion­ships with acad­e­mia, drug/de­vice mak­ers and in­sur­ers. On Thurs­day, an ear­ly study sug­gest­ed that a range of Ap­ple de­vices in com­bi­na­tion with dig­i­tal ap­pli­ca­tions could dis­tin­guish peo­ple with mild cog­ni­tive im­pair­ment (MCI), mild Alzheimer’s dis­ease, de­men­tia and those with­out symp­toms.

The 12-week study eval­u­at­ed 113 par­tic­i­pants, aged 60 to 75, in re­al-world set­tings to de­ter­mine whether Ap­ple de­vices (iPhone, Ap­ple Watch, iPad and the Bed­dit sleep mon­i­tor) in com­bi­na­tion with apps, were able to iden­ti­fy al­most im­per­cep­ti­ble cog­ni­tive and be­hav­ioral dif­fer­ences among the study par­tic­i­pants with and with­out mild cog­ni­tive im­pair­ment.

The study was con­duct­ed by Ap­ple, Eli Lil­ly and Ev­i­da­tion Health — a tech­nol­o­gy com­pa­ny that de­vel­oped a plat­form to se­cure par­tic­i­pants’ con­sent to col­lect and an­a­lyze 16 ter­abytes of da­ta from sources in­clud­ing sen­sor da­ta, ques­tion­naires about mood and en­er­gy, and a dig­i­tal as­sess­ment ap­pli­ca­tion that as­sessed psy­chomo­tor tasks.

Nik­ki Marin­sek

“We know that in­sights from smart de­vices and dig­i­tal ap­pli­ca­tions can lead to im­proved health out­comes, but we don’t yet know how those re­sources can be used to iden­ti­fy and ac­cel­er­ate di­ag­noses,” said Nik­ki Marin­sek, who is a da­ta sci­en­tist at Ev­i­da­tion Health, in a state­ment. “The re­sults of the tri­al set the ground­work for fu­ture re­search that may be able to help iden­ti­fy peo­ple with neu­rode­gen­er­a­tive con­di­tions ear­li­er than ever be­fore.”

For Lil­ly $LLY, which has suf­fered a string of set­backs in Alzheimer’s dis­ease much like its peers, the re­sults are en­cour­ag­ing as re­searchers in­creas­ing­ly put their faith in the­o­ries that fa­vor bat­tling the dis­ease at ear­li­er stages for suc­cess. About 8 months ago, the In­di­anapo­lis-based drug­mak­er inked an up to $2 bil­lion Alzheimer’s deal for tau ther­a­pies with Switzer­land-based AC Im­mune.

Tim Cook Ap­ple

Ear­ly in 2019, Ap­ple $AAPL CEO Tim Cook pre­dict­ed that in the fu­ture, his com­pa­ny’s great­est con­tri­bu­tion will be its im­pact on health. The lat­est it­er­a­tion of Ap­ple Watch con­tains a sim­ple elec­tro­car­dio­gram able to de­tect signs of atri­al fib­ril­la­tion (AFib) — a com­mon heart con­di­tion that rais­es the risk of stroke and is typ­i­cal­ly seen in the el­der­ly. While the FDA signed off on the sen­sor — Ap­ple has been care­ful to un­der­score that the watch can’t di­ag­nose any­thing or re­place a doc­tor.

Mean­while, the com­pa­ny has inked a num­ber of deals in the health­care in­dus­try, in­clud­ing join­ing forces with John­son & John­son $JNJ to test the di­ag­no­sis and out­comes of AFib pa­tients in a clin­i­cal tri­al; last year it part­nered with med­ical de­vice mak­er Zim­mer Bio­met $ZBH in a bid to use the health da­ta cap­tured by the watch to de­ter­mine why some pa­tients re­cov­er faster from knee and hip re­place­ments; and in 2017, the com­pa­ny tied up with Stan­ford Uni­ver­si­ty to eval­u­ate pre­vi­ous edi­tions of the watch in a large-scale heart study.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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FDA to Sarep­ta: Your wide­ly an­tic­i­pat­ed fol­lowup to Ex­ondys 51 is not get­ting an ac­cel­er­at­ed OK for Duchenne MD

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabriva Therapeutics suffered a setback after the FDA rejected its antibiotic for complicated urinary tract infections — the Novartis spinoff has now had some better luck with the US agency, which on Monday approved its other drug for community-acquired bacterial pneumonia.

The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.