Un­der new lead­er­ship, No­var­tis' San­doz unit breaks up with dig­i­tal ther­a­peu­tics out­fit Pear

Looks like No­var­tis’ San­doz unit — un­der new lead­er­ship — has sev­ered ties with Pear Ther­a­peu­tics, dis­solv­ing the part­ner­ship that was inked in 2018.

Last year, San­doz and Pear col­lab­o­rat­ed on and launched re­SET, an FDA-ap­proved dig­i­tal ther­a­peu­tic de­signed to de­liv­er cog­ni­tive be­hav­ioral ther­a­py over 12 weeks to pa­tients with sub­stance abuse dis­or­der (SUD) who are in out­pa­tient treat­ment un­der the su­per­vi­sion of a doc­tor. The Swiss drug­mak­er al­so in­vest­ed in Pear’s Se­ries B round of fi­nanc­ing an­nounced in Jan­u­ary 2018.

The fu­ture of No­var­tis’ gener­ics unit San­doz is un­cer­tain — as price ero­sion in the Unit­ed States fu­els spec­u­la­tion that No­var­tis chief Vas Narasimhan might pre­fer to spin it off to sharp­en fo­cus on de­vel­op­ing new treat­ments.

Richard Saynor No­var­tis

In March, San­doz CEO Richard Fran­cis abrupt­ly ten­dered his res­ig­na­tion, sug­gest­ing he couldn’t com­mit to the ‘mul­ti-year’ trans­for­ma­tion that San­doz was em­bark­ing on. Fran­cis was re­placed by Richard Saynor, SVP clas­sic & es­tab­lished prod­ucts, com­mer­cial & dig­i­tal plat­forms at GSK — al­though he was with San­doz pri­or to that stint.

The “de­ci­sion to tran­si­tion com­mer­cial­iza­tion re­spon­si­bil­i­ties for re­SET and re­SET-O is part of San­doz trans­for­ma­tion and sub­se­quent lead­er­ship change, which has re­sult­ed in a re­in­forced fo­cus on and cap­i­tal al­lo­ca­tion for San­doz core busi­ness,” the com­pa­ny said in a state­ment on Tues­day.

Pre­scrip­tion dig­i­tal ther­a­peu­tics — such as re­SET and Abil­i­fy Mycite, the first dig­i­tal pill that car­ries an em­bed­ded sen­sor to track if pa­tients are tak­ing their med­ica­tion prop­er­ly — are val­i­dat­ed in ran­dom­ized clin­i­cal tri­als to demon­strate safe­ty and ef­fi­ca­cy.

The FDA ap­proved re­SET in 2017, on the ba­sis of a NI­DA-spon­sored tri­al in­volv­ing 399 pa­tients with SUD. Pa­tients were ran­dom­ized to re­ceive stan­dard treat­ment — com­pris­ing in­ten­sive face-to-face coun­sel­ing — or re­duced amount of face-to-face coun­sel­ing plus the dig­i­tal ther­a­peu­tic. Pa­tients on the dig­i­tal ther­a­peu­tic more than dou­bled the rate of ab­sti­nence com­pared to stan­dard face-to-face coun­sel­ing. Pear Ther­a­peu­tics is al­so de­vel­op­ing dig­i­tal ther­a­peu­tics for a host of oth­er dis­or­ders in­clud­ing schiz­o­phre­nia, PTSD and gen­er­al anx­i­ety dis­or­der. In De­cem­ber 2018, the FDA ap­proved re­SET-O, for the opi­oid use dis­or­der.

Dig­i­tal ther­a­peu­tics is an um­brel­la term that in­cludes tech­nol­o­gy such as wear­able de­vices, mo­bile apps and telemed­i­cine plat­forms — which is typ­i­cal­ly dri­ven by soft­ware to pre­vent, man­age, or treat dis­or­ders, in­de­pen­dent­ly or in con­cert with med­ica­tion and/or med­ical de­vices. These tools are large­ly de­signed to ad­dress chron­ic dis­eases such as di­a­betes, heart or res­pi­ra­to­ry dis­or­ders, by tar­get­ing be­hav­iors such as di­et, ex­er­cise, and lifestyle that have a sig­nif­i­cant im­pact on the in­ci­dence and man­age­ment of dis­ease.

Al­though the rapid pen­e­tra­tion of smart­phones and tablets and low­er health­care costs have dri­ven the growth of the glob­al dig­i­tal ther­a­peu­tics mar­ket, pri­va­cy con­cerns could tem­per the pace of adop­tion. Still, the size of the glob­al dig­i­tal ther­a­peu­tics mar­ket is ex­pect­ed to hit about $7.83 bil­lion by 2025, from $1.75 bil­lion in 2017 — ac­cord­ing to Al­lied Mar­ket Re­search es­ti­mates.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.