A child plays Akili's FDA-approved EndeavorRx video game to treat ADHD.

Ak­ili taps new com­mer­cial chief in ad­vance of fall mar­ket­ing launch for AD­HD video game ther­a­py

As Ak­ili In­ter­ac­tive preps its AD­HD video game ther­a­py for com­mer­cial launch – and builds out its new Roblox part­ner­ship – it’s tap­ping com­mer­cial vet­er­an Matt Franklin to lead the way.

Matt Franklin

Franklin will join Ak­ili lat­er this month as pres­i­dent and chief op­er­at­ing of­fi­cer with a fo­cus on the com­mer­cial launch and mar­ket­ing of En­deav­or­Rx, its FDA-ap­proved cog­ni­tive ther­a­py for at­ten­tion deficit hy­per­ac­tiv­i­ty dis­or­der, lat­er this year. His du­ties in­clude over­see­ing day-to-day op­er­a­tions at Ak­ili across com­mer­cial, prod­uct, en­gi­neer­ing, med­ical and em­ploy­ee tal­ent.

Franklin was most re­cent­ly gen­er­al man­ag­er of Ex­act Sci­ences’ pre­ci­sion on­col­o­gy di­vi­sion. Be­fore that he led com­mer­cial at Thrive Ear­li­er De­tec­tion – ac­quired by Ex­act Sci­ences in 2020 – bring­ing its ear­ly de­tec­tion mul­ti-can­cer blood test to mar­ket.

Ak­ili’s En­deav­or­Rx game is ap­proved for 8-to-12-year-olds with rough­ly 25-minute 5-mis­sion ses­sions. The rac­ing game ven­tures through imag­i­nary worlds and prob­lem-solv­ing tasks de­vel­oped specif­i­cal­ly “to tar­get ar­eas of the brain that play a key role in at­ten­tion func­tion.”

Ali­ki cur­rent­ly part­ners with an on­line tele­health provider for pre­scrib­ing and doc­tors are pre­scrib­ing it in of­fice, how­ev­er the soft­ware com­pa­ny is plan­ning its full re­lease with a big mar­ket­ing push in the fall. Last year, Ak­ili launched an in­tro­duc­to­ry on­line mar­ket­ing cam­paign with re­al par­ents and kids with AD­HD who use the soft­ware.

Ed­die Mar­tuc­ci

In an­oth­er boost to its mar­ket­ing ef­forts, Ak­ili ce­ment­ed a deal with pop­u­lar ado­les­cent video gam­ing plat­form Roblox in May. The deal con­nects pa­tients’ En­deav­or­Rx treat­ment to re­wards in the Roblox vir­tu­al re­al­i­ty game, but will add new op­por­tu­ni­ties “as the part­ner­ship pi­lot con­tin­ues rolling out,” Ak­ili CEO and co-founder Ed­die Mar­tuc­ci said in an email in­ter­view.

“At Ak­ili, we’re work­ing to chal­lenge tra­di­tion­al per­cep­tions of med­i­cine, while Roblox has led its in­dus­try with the cre­ation of a vir­tu­al world that brings over 55M peo­ple to­geth­er each day through im­mer­sive shared ex­pe­ri­ences. To­geth­er, we have the abil­i­ty to com­plete­ly reimag­ine the pa­tient ex­pe­ri­ence,” he said.

En­deav­or­Rx is Ak­ili’s first prod­uct, how­ev­er, it is plan­ning and test­ing dis­ease mod­i­fy­ing dig­i­tal ther­a­pies in ma­jor de­pres­sive dis­or­der, autism spec­trum dis­or­der, mul­ti­ple scle­ro­sis and Covid brain fog.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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