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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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