Brian Harris, MedRhythms CEO

Bio­gen taps dig­i­tal ther­a­peu­tics biotech for mu­sic-based ther­a­py to help peo­ple with MS im­prove their walk­ing

In the past decade, dig­i­tal health­care has been get­ting big — and now it’s sad­dling up with Big Phar­ma. As the lat­est phar­ma to take a swing at dig­i­tal ther­a­py, Bio­gen has li­censed an in­ves­ti­ga­tion­al pre­scrip­tion ther­a­py meant to help pa­tients with mul­ti­ple scle­ro­sis (MS) im­prove their gait from MedRhythms, a Port­land, ME-based biotech.

For the ther­a­py, dubbed MR-004, MedRhythms is re­ceiv­ing $3 mil­lion up­front and can get up to $117.5 mil­lion more in down­stream mile­stones, ac­cord­ing to the press re­lease.

The dig­i­tal ther­a­py “us­es a com­bi­na­tion of sen­sors, soft­ware, and mu­sic” to im­prove walk­ing for peo­ple with MS. Gait prob­lems are one of the most com­mon symp­toms of MS, and cur­rent treat­ment op­tions in­clude phys­i­cal ther­a­py as well as an oral med­ica­tion known as Ampyra (dal­fam­pri­dine), which aims to help the nerves con­duct sig­nals through the body.

Mar­tin Dubuc

“As part of our as­pi­ra­tion in dig­i­tal health, to­geth­er with MedRhythms we aim to ad­vance a new, in­no­v­a­tive treat­ment op­tion for peo­ple liv­ing with MS that may help ad­dress walk­ing im­pair­ment, a com­mon is­sue that im­pacts their over­all qual­i­ty of life,” Bio­gen’s head of dig­i­tal health Mar­tin Dubuc said.

While the dig­i­tal MS ther­a­py is still in fea­si­bil­i­ty stud­ies, if it reach­es ap­proval, it would be the first pre­scrip­tion dig­i­tal ther­a­py for a con­di­tion that af­fects many pa­tients who have MS.

Bio­gen is not the on­ly phar­ma com­pa­ny try­ing to get in­to dig­i­tal ther­a­peu­tics. Just last week, Sanofi penned a mul­ti-year deal with Dar­i­o­Health, which is push­ing AI-based apps for man­ag­ing a va­ri­ety of chron­ic health con­di­tions.

MedRhythms’ ap­proach fo­cus­es most­ly on pre­scrip­tion treat­ments for con­di­tions re­lat­ed to neu­ro­log­i­cal dis­eases, lever­ag­ing a form of mu­sic ther­a­py known as “Rhyth­mic Au­di­to­ry Stim­u­la­tion.” The com­pa­ny al­so boasts a dig­i­tal walk­ing ther­a­py for pa­tients re­cov­er­ing from stroke, which re­ceived a break­through de­vice des­ig­na­tion from the FDA in 2020.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.