No­var­tis wants to be a leader in a new gen­er­a­tion of pre­scrip­tion dig­i­tal med pro­grams, pairs with Pear

The new­ly emerg­ing field of pre­scrip­tion dig­i­tal med­i­cine is tak­ing a big step for­ward to­day.

Phar­ma gi­ant No­var­tis $NVS is pair­ing up with Pear Ther­a­peu­tics, one of the lead­ing pi­o­neers in the are­na, to de­vel­op new mo­bile apps for pa­tients with schiz­o­phre­nia and mul­ti­ple scle­ro­sis.

Joris van Dam

You may re­call that Pear broke new ground a few months ago by gain­ing an FDA ap­proval for an app de­signed to help pa­tients with sub­stance abuse dis­or­der. Now the Boston/Bay Area-based biotech will work with Joris van Dam, the ex­ec­u­tive di­rec­tor for dig­i­tal ther­a­peu­tics at the No­var­tis In­sti­tutes for Bio­Med­ical Re­search, on in­ter­ac­tive dig­i­tal pro­grams for schiz­o­phre­nia and mul­ti­ple scle­ro­sis.

Get­ting a heavy­weight play­er in the bio­phar­ma in­dus­try to col­lab­o­rate with 5-year-old Pear is a big plus for dig­i­tal med­i­cine, where cog­ni­tive be­hav­ioral pro­grams are be­ing de­vel­oped to help pa­tients with chron­ic dis­or­ders. And the FDA is play­ing a key as­sist in the field, with new guide­lines in the works on how these pro­grams can prove them­selves to of­fer proof of ef­fi­ca­cy and safe­ty.

These aren’t the av­er­age kind of apps you may be fa­mil­iar with on your phone.

“These are ther­a­peu­tic treat­ments pre­scribed by doc­tors and used by pa­tients,” says van Dam. “You should treat it like a drug ther­a­py, ex­cept it’s be­ing pre­scribed and ful­filled by the cloud and not by the phar­ma­cy.”

No­var­tis and Pear are plan­ning on set­ting up clin­i­cal tri­als that can, for ex­am­ple, test how these in­ter­ac­tive pro­grams work on con­trol­ling the pos­i­tive and neg­a­tive symp­toms as­so­ci­at­ed with schiz­o­phre­nia — in­clud­ing how you re­spond to hear­ing voic­es.

And No­var­tis sees some ready ben­e­fits in keep­ing a cog­ni­tive be­hav­ioral pro­gram in your pock­et. Un­like a ther­a­pist, says v

an Dam, you can run through a 15-minute pro­gram at your con­ve­nience, with­out jour­ney­ing to a ses­sion. And they’ll have clin­i­cians gath­er the da­ta need­ed to meet the re­quired end­points, stan­dards which are cur­rent­ly un­der re­view in a pi­lot pro­gram that in­cludes Pear.

So how long will this process take?

Van Dam says that’s un­cer­tain, but he feels that there’s a lot of po­ten­tial for a full slate of these dig­i­tal meds.

There’s no word on the ex­act terms, but No­var­tis is of­fer­ing a fa­mil­iar slate of up­front, re­search sup­port, mile­stones and roy­al­ties.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

UP­DAT­ED: Pan­el of neu­ro­science ex­perts lays out the com­pli­ca­tions with us­ing Bio­gen's new Alzheimer's drug

Treatment of early Alzheimer’s patients with Biogen’s new drug Aduhelm should closely resemble how the drug was studied in its pivotal clinical trials, according to new recommendations from a panel of neuroscience experts led by UNLV’s Jeffrey Cummings.

“Those considering aducanumab therapy should understand that the expected benefit is slowing of cognitive and functional decline; improvement of the current clinical state is not anticipated,” they wrote Tuesday in The Journal of Prevention of Alzheimer’s Disease, noting that some of their recommendations are more specific or more restrictive than the information provided in the FDA’s prescribing information.

Christophe Weber, Takeda CEO (Kyodo via AP Images)

Take­da flesh­es out CNS pact with pep­tide drug­mak­er, set­ting aside $3.5B in fu­ture mile­stones

One of a suite of drugmakers looking to reinvest in the neuroscience space, Takeda has been aggressive in signing on new partners to help build up its pipeline in that space. But sometimes the best partner is the one you already have.

Takeda will set aside $3.5 billion in future milestones and an undisclosed upfront payment to build out its drug discovery deal with Japanese peptide conjugate maker PeptiDream, adding neurodegeneration to the partnership’s list of CNS targets, the companies said Tuesday.

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George Yancopoulos, Regeneron

Re­gen­eron's lat­est ge­net­ics dis­cov­ery hooks As­traZeneca — now all-in on de­vel­op­ing small mol­e­cules for obe­si­ty

Just weeks after its widely lauded genetics research arm tagged a promising new target for obesity, Regeneron has signed up an industry heavyweight to collaborate with on developing new drugs that can potentially act as a game-changer in what has proven to be a tough field for developers.

The Regeneron Genetics Center published a paper in Science at the beginning of this month highlighting how their work sequencing the genomes of 650,000 people highlighted how people with at least 1 inactive copy of the GPR75 gene weighed on average 12 pounds less than the rest of the population with a 54% reduction in risk of obesity.

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