EndeavorRx screen (Akili Interactive)

FDA ap­proves first ther­a­peu­tic video game

Here’s a new one: The FDA has just ap­proved a pre­scrip­tion video game.

The brain­child of a cou­ple of cog­ni­tive sci­en­tists who built the pro­to­type tech­nol­o­gy over a decade ago, the video game is de­signed to help im­prove at­ten­tion func­tion in kids with AD­HD. It was de­vel­oped by Ak­ili In­ter­ac­tive, one of two ma­jor health tech video game com­pa­nies, and is called En­deav­or­Rx.

Doc­tors can pre­scribe it for kids ages 8 to 12 with AD­HD and a his­to­ry of at­ten­tion is­sues. A price has yet to be an­nounced, but an Ak­ili spokesper­son said in an email that they are work­ing to get cov­er­age from in­sur­ers and to “ex­pect pric­ing to be in the range of oth­er treat­ments like drugs and be­hav­ioral ther­a­py cur­rent­ly used in chil­dren with AD­HD.”

Adam Gaz­za­ley

The ap­proval is the cul­mi­na­tion of a years-long ef­fort to con­vince reg­u­la­tors that a video game could even be a pre­scrip­tion ther­a­py. Ak­ili was found­ed in 2011, with tech­nol­o­gy li­censed from Adam Gaz­za­ley’s lab at the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, and got ear­ly back­ing from Pfiz­er, Shire and PureTech, among oth­ers. (Pear Ther­a­peu­tics, the oth­er ma­jor com­pa­ny in the space, was found­ed 2 years lat­er.) The idea was that, with the right al­go­rithms, a game could re­train neur­al net­works and help peo­ple with cer­tain cog­ni­tive dis­or­ders mul­ti­task, fo­cus, and process in­for­ma­tion.

Even as they test­ed the soft­ware in Alzheimer’s, AD­HD, de­pres­sion and autism, they en­coun­tered skep­ti­cism about the po­ten­tial im­pact. A 2013 meta-analy­sis an­a­lyzed 46 ex­per­i­ments on video games, and found they pro­duced “neg­li­gi­ble ef­fects for ex­ec­u­tive func­tion.” Ak­ili first asked for FDA ap­proval in mid-2018. For drugs, at least, a de­ci­sion gen­er­al­ly comes with­in 10 months.

En­deav­or­Rx was fi­nal­ly ap­proved based on 5 clin­i­cal tri­als, in­clud­ing a study pub­lished on April 1 in The Lancet Dig­i­tal Health that found that 25 min­utes of game play per day, 5 days a week, for 4 weeks “might be used to im­prove ob­jec­tive­ly mea­sured in at­ten­tion in pe­di­atric pa­tients with AD­HD.” It was cleared un­der the FDA’s De No­vo pro­gram for a new type of low- or mod­er­ate-risk de­vice.

Al­though on­ly ap­proved to­day, the game has ac­tu­al­ly been avail­able for over a month. In April, the FDA re­laxed reg­u­la­tions for low-risk men­tal health de­vices, and Ak­ili launched a site that al­lowed chil­dren to get the game for free for up to three months.

The game sends kids through land­scapes teem­ing with la­va or ice, or on un­der­wa­ter mis­sions, and re­wards them for com­plet­ing var­i­ous tasks.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Covid-19 roundup: EU backs Os­i­vax's pur­suit of a uni­ver­sal vac­cine to fight Covid-19

The race to find a vaccine for the novel coronavirus continues to heat up, as the European Commission’s pilot R&D arm taps French biotech Osivax to head up its unique approach to the research.

Aiming to develop a universal jab for the flu and Covid-19, Osivax secured around $20 million in “blended financing” from the European Innovation Council. About $3 million comes from a Covid-19 “accelerator grant” and will go toward completing Osivax’s signature flu vaccine, dubbed OVX836 and currently in Phase IIa. The rest will be included as part of Osivax’s Series B funding, which aims to launch the Phase IIb portion of the study.

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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Adrian Gottschalk, Foghorn CEO

Mer­ck dan­gles up to $425 mil­lion to team with Flag­ship’s Foghorn Ther­a­peu­tics on drug­ging the shape of DNA

Two years after it first emerged from stealth mode, Flagship’s Foghorn Therapeutics has nabbed its first Big Pharma partner as Merck signs on to the biotech’s vision of drugging the very shape of DNA.

The deal, worth up to $425 million but with the upfront cash undisclosed, comes as Foghorn nears a pivot to a clinical stage biotech. The Cambridge-based company has added nearly 60 staffers from the 25 it had when it first emerged out of Flagship and, CEO Adrian Gottschalk said, they have finally refined the screening technology at the heart of the company, with plans to file their first IND towards the end of the year.

John Reed, Sanofi R&D chief (Endpoints News)

John Reed brings NK cells in­to Sanofi's CD38 ri­val­ry with J&J — and of­fers thumbs up for Kiadis' new fo­cus

Sanofi doesn’t just want to be a challenger to J&J’s dominant Darzalex multiple myeloma franchise. It’s looking to pioneer a new approach by pairing its own — newly approved — anti-CD38 drug with an NK cell therapy it’s just picked up.

The French pharma giant has teed up $19.7 million (€17.5 million) upfront and close to a billion dollars (€857.5 million) in milestones for a license to Kiadis Pharma’s preclinical K-NK004 program, which consists of NK cells that have been genetically engineered not to express CD38.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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