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.

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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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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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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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.”

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.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.