The FDA will look at us­ing a non-in­va­sive test method, rather than liv­er biop­sies, to de­ter­mine re­sults in some tri­als of MASH drugs, a mea­sure that could even­tu­al­ly make it eas­i­er to en­roll pa­tients and check the progress of the drugs.

On Wednes­day, the agency said it had ac­cept­ed a let­ter of in­tent from a com­pa­ny seek­ing to qual­i­fy liv­er stiff­ness mea­sure­ment by vi­bra­tion-con­trolled tran­sient elas­tog­ra­phy (VCTE) as a “rea­son­ably like­ly sur­ro­gate end­point” for clin­i­cal tri­als in adult MASH pa­tients with mod­er­ate-to-ad­vanced fi­bro­sis.

The tech­nique in­volves us­ing ul­tra­sound sig­nals to mea­sure stiff­ness of the liv­er, which can help as­sess scar­ring, or fi­bro­sis.

Fol­low­ing the FDA's more lim­it­ed ap­provals of sev­er­al Covid-19 vac­cines on Wednes­day, CBER Di­rec­tor Vinay Prasad laid out why the agency de­cid­ed to re­scind Pfiz­er's emer­gency use au­tho­riza­tion for its mR­NA vac­cine for younger chil­dren, and where it dis­agreed with the com­pa­ny.

In an agency memo re­leased late Wednes­day, Prasad said Pfiz­er ar­gued to the agency that pulling its EUA could make health­care work­ers think there were safe­ty is­sues with its vac­cine. The com­pa­ny al­so said the ac­tion could cre­ate sup­ply short­ages, and that Mod­er­na's la­bel for its vac­cine "does not ad­dress chil­dren who be­gan their se­ries with the Pfiz­er-BioN­Tech Covid-19."

In the memo, Prasad said the CDC had al­ready pro­vid­ed guid­ance on how to con­tin­ue vac­cine se­ries for those who start­ed on Pfiz­er's vac­cine, and al­so that there was­n't ev­i­dence that Mod­er­na won't have enough sup­plies.

The FDA has once again shot down Out­look Ther­a­peu­tics’ at­tempt to get its ver­sion of be­va­cizum­ab ap­proved for wet AMD, stip­u­lat­ing it "can­not ap­prove the ap­pli­ca­tion in its present form," the com­pa­ny an­nounced Thurs­day.

Out­look has been seek­ing FDA ap­proval for its ver­sion of be­va­cizum­ab in wet AMD, where the drug has long been used off-la­bel. Roche mar­kets be­va­cizum­ab as the can­cer drug Avastin, but it be­came com­mon­ly used off-la­bel to treat wet AMD be­cause it was far less ex­pen­sive com­pared to an­oth­er Roche drug, Lu­cen­tis.

Both Avastin and Lu­cen­tis block a pro­tein called vas­cu­lar en­dothe­lial growth fac­tor (VEGF). Out­look’s ver­sion of the an­ti­body is called be­va­cizum­ab gam­ma. The com­pa­ny has said its drug, if ap­proved, would not be a biosim­i­lar.

A decade ago, 70% of Scripps Re­search’s fund­ing came from gov­ern­ment grants. But that share is now 30%, af­ter Scripps rein­vent­ed its fi­nan­cial mod­el to re­duce its de­pen­dence on Wash­ing­ton.

The shift has left Scripps bet­ter po­si­tioned than many oth­er re­search in­sti­tutes to with­stand the bil­lions of dol­lars in sci­ence fund­ing cuts from the Trump ad­min­is­tra­tion.

Scripps, which has near­ly $1.3 bil­lion in as­sets, of­fers a dif­fer­ent fi­nan­cial mod­el for bio­med­ical re­search. It’s push­ing dis­cov­er­ies in­to clin­i­cal tri­als, and launch­ing a fund backed by pri­vate in­vestors, a much more ex­pan­sive role com­pared to re­search in­sti­tutes that typ­i­cal­ly stick to ear­ly-stage drug dis­cov­ery.

Wal­greens named Mike Motz as its new CEO.

The tran­si­tion comes as New York-based pri­vate eq­ui­ty firm Sycamore Part­ners clos­es its $10 bil­lion take-pri­vate deal for the re­tail phar­ma­cy chain on Thurs­day, mark­ing the end of Wal­green­s' near­ly cen­tu­ry-long streak as a pub­lic com­pa­ny.

Motz pre­vi­ous­ly served as the CEO of Sycamore-owned of­fice sup­plies re­tail chain Sta­ples and worked as the pres­i­dent of Cana­di­an phar­ma­cy chain Shop­pers Drug Mart. He re­places Tim Went­worth, who was hired to run Wal­greens in 2023 with hopes of turn­ing the busi­ness around af­ter its strug­gles in re­cent years with on­line com­pe­ti­tion, a drop in con­sumer spend­ing, shrink­ing re­im­burse­ment rates for drugs, and a pricey pur­chase of a clin­ic chain, among oth­er is­sues that af­fect­ed its bot­tom line.

Ngai has a sto­ry out to­day about Twin Health, a start­up that raised $53 mil­lion in a Se­ries E round this month at a $950 mil­lion val­u­a­tion.

The com­pa­ny us­es sen­sors and wear­ables like con­tin­u­ous glu­cose mon­i­tors and smart­watch­es to gath­er da­ta about an in­di­vid­ual’s meta­bol­ic health. With that in­for­ma­tion, Twin’s pro­gram acts as a vir­tu­al rep­re­sen­ta­tion of the per­son, mak­ing rec­om­men­da­tions about eat­ing and ex­er­cise. It’s a con­cept known as “dig­i­tal twins.”

The da­ta are com­pelling: Twin Health pub­lished re­sults from a ran­dom­ized tri­al of 150 peo­ple with type 2 di­a­betes in NE­JM Cat­a­lyst ear­li­er this month that found 71% of par­tic­i­pants who used Twin Health’s in­ter­ven­tion were able to get their A1c lev­els be­low 6.5% af­ter a year, com­pared to 2.4% who were able to achieve that lev­el with stan­dard of care. The ap­pro