Time Pas­sages: Bruce Gold­smith out at Jim Wilson's gene ther­a­py biotech; Flag­ship re­veals Michael Sev­eri­no’s CEO gig

Bruce Gold­smith

→ When Pas­sage Bio read­just­ed its pipeline pri­or­i­ties, pruned its work­force by 13% and saw its R&D chief Eliseo Sali­nas walk out in March, it would be nat­ur­al to as­sume that this con­flu­ence of events could lead to more im­mi­nent changes. This week, CEO Bruce Gold­smith fol­lowed Sali­nas and board mem­ber Liam Rat­cliffe out the door.

Pas­sage Bio and Gold­smith both felt it was in their best in­ter­ests to move on as the Jim Wil­son biotech shifts its fo­cus to GM1 gan­gliosi­do­sis, Krabbe dis­ease and fron­totem­po­ral de­men­tia. Gen­er­al coun­sel and cor­po­rate sec­re­tary Edgar “Chip” Cale has been named in­ter­im chief as the search gets un­der­way for Gold­smith’s re­place­ment, hav­ing leaped to Pas­sage Bio in 2019 af­ter a 21-year ca­reer at GSK that con­clud­ed as SVP, le­gal cor­po­rate projects. Gold­smith left Deer­field to suc­ceed co-founder Stephen Squin­to as Pas­sage Bio’s CEO in ear­ly 2020.

Michael Sev­eri­no

→ Back in April, Ab­b­Vie ex­ec Michael Sev­eri­no was one of three peo­ple who were named CEO-part­ners at Flag­ship Pi­o­neer­ing in rapid suc­ces­sion (Mar­go Geor­giadis and All­tr­na’s Michelle Wern­er were the oth­ers). Sev­eri­no has tak­en the wheel at gene writ­ing out­fit Tessera, which re­loaded with a Se­ries C north of $300 mil­lion not long af­ter the Am­gen and Mer­ck alum joined Flag­ship. In his eight years at Ab­b­Vie, Sev­eri­no was EVP of R&D, CSO, and even­tu­al­ly vice chair­man and pres­i­dent. “The lega­cy that I think is most im­por­tant is the drugs that one has brought to mar­ket, the un­met need that those ther­a­pies have ad­dressed,” he told End­points News. “And we’ve been for­tu­nate across all the com­pa­nies that I’ve been a part of to bring some in­cred­i­ble ther­a­peu­tics to the mar­ket.”

Ge­off von Maltzahn, the face of Tessera since its found­ing, will now be­come chair­man of the board.

Ma­ri­na Hong

→ A cou­ple of pro­mo­tions have been doled out at Bay­er, as Bri­an Bran­ca moves up to CFO of Bay­er US while Ma­ri­na Hong will re­place the re­tir­ing Lisa Mas­sa as head of US hu­man re­sources ef­fec­tive June 6. A Bay­er vet since 2006, Bran­ca had pre­vi­ous­ly been US VP and trea­sur­er since No­vem­ber 2018, and for the last year, Hong led hu­man re­sources for Bay­er Phar­ma­ceu­ti­cals Amer­i­c­as. The phar­ma gi­ant backed out of a $670 mil­lion CAR-T part­ner­ship with Atara Bio­ther­a­peu­tics a cou­ple weeks ago, putting a crimp in the biotech’s pipeline plans.

Matt An­gel

→ The top brass at Brook­lyn Im­munoTher­a­peu­tics is un­der­go­ing some changes as CEO Howard Federoff steps down “to fo­cus on build­ing a new ven­ture” and Matt An­gel swoops in to take his place. It’s a nat­ur­al fit for An­gel, who co-found­ed, chaired and was chief ex­ec­u­tive at Fac­tor Bio­science, the Cam­bridge, MA biotech that li­censed its mR­NA-based gene edit­ing tech­nol­o­gy to Brook­lyn last year. Just weeks be­fore that agree­ment, Federoff joined Brook­lyn from As­pen Neu­ro­science, guid­ing the Parkin­son’s play­er to its $70 mil­lion Se­ries A round in April 2020.

In oth­er Brook­lyn news, An­drew Jack­son — the fi­nance chief and one-time in­ter­im CEO of Ra Med­ical Sys­tems — has been named CFO.

Kar­tik Kr­ish­nan

Ar­cus Bio­sciences didn’t di­vulge any specifics, but CEO Ter­ry Rosen did main­tain a pos­i­tive out­look for the ARC-7 study in the com­pa­ny’s Q1 re­port on May 9. Four days lat­er, CMO Kar­tik Kr­ish­nan told our Kyle LaHu­cik that he was leav­ing Ar­cus, and true to his word — “I’ve nev­er tak­en a month off,” he said — Kr­ish­nan has been named CMO of Texas-based On­co­Nano Med­i­cine. An Am­gen vet, Kr­ish­nan is a for­mer se­nior med­ical di­rec­tor with Bio­Marin, Five Prime Ther­a­peu­tics and Genen­tech. A Phase II study at On­co­Nano is in progress for its lead pro­gram, a flu­o­res­cent nanoprobe known as pegsita­cia­n­ine.

Julie Lep­in

→ As Sana Biotech­nol­o­gy banks on $100 mil­lion in sav­ings as it shifts man­u­fac­tur­ing plans to Wash­ing­ton state, the com­pa­ny has al­so an­nounced the ap­point­ments of Sne­hal Pa­tel as VP and head of man­u­fac­tur­ing and Julie Lep­in as SVP and head of reg­u­la­to­ry, safe­ty and qual­i­ty. Pa­tel hails from Bris­tol My­ers Squibb, where he served as glob­al head and VP for cell man­u­fac­tur­ing. Pri­or to that, Pa­tel had an 18-year stint at Genen­tech/Roche, serv­ing in a num­ber of roles in­clud­ing head of qual­i­ty op­er­a­tions and head of drug prod­uct op­er­a­tions.

Mean­while, Lep­in makes her way to the Seat­tle-based com­pa­ny from Am­gen, where she was VP, reg­u­la­to­ry af­fairs for on­col­o­gy, with an ap­proval for Lumakras in her port­fo­lio. Ad­di­tion­al­ly, Lep­in has served as head of reg­u­la­to­ry at Juno Ther­a­peu­tics and head of reg­u­la­to­ry, on­col­o­gy at Mer­ck.

Stacey Ma

While Pa­tel and Lep­in get ac­quaint­ed at Sana, a Women in Bio­phar­ma R&D hon­oree from 2020 bids farewell. Ef­fec­tive Ju­ly 22, Stacey Ma will move on to Gilead as EVP, phar­ma­ceu­ti­cal de­vel­op­ment and she’ll re­place Taiyin Yang, who re­tires af­ter near­ly 30 years with the com­pa­ny. Ma worked for Genen­tech/Roche from 1996-2019 be­fore join­ing Sana.

Smi­tal Shah

→ Not on­ly is Pro­QR dis­miss­ing 30% of its work­force as its pipeline dwin­dles, its ex­ec­u­tive lead­er­ship is un­der­go­ing a big re­vamp, as the Dutch biotech brings back René Beuke­ma as chief cor­po­rate de­vel­op­ment of­fi­cer and gen­er­al coun­sel and hands the CSO job to sci­en­tif­ic co-founder Ger­ard Platen­burg. Else­where at Pro­QR, chief busi­ness and fi­nan­cial of­fi­cer Smi­tal Shah will leave at the end of the year and the search is on for her re­place­ment. Beuke­ma, a Cru­cell vet who held these very roles at Pro­QR from 2013-18, had spent the last three years at Frame Can­cer Ther­a­peu­tics, and Platen­burg slides in­to the CSO post af­ter eight years as chief in­no­va­tion of­fi­cer.

And in a small edi­tion of the Maraganore Me­ter, ex-Al­ny­lam CEO John Maraganore “will ex­tend his com­mit­ment as a strate­gic ad­vi­sor to the Su­per­vi­so­ry Board,” per the re­lease, af­ter throw­ing his hat in the ring in March.

Sergey Yurasov

→ Spe­cial­iz­ing in what they call “Mas­terKey” ther­a­pies, Black Di­a­mond has in­stalled Sergey Yurasov as CMO. The biotech couldn’t dodge the slings and ar­rows of the bear mar­ket, lay­ing off al­most a third of its em­ploy­ees in late April. Yurasov had held the same po­si­tion at David Hung’s Nu­va­tion Bio, and he was CMO of Im­mune De­sign be­fore Mer­ck forked over $300 mil­lion for the com­pa­ny three years ago. Karsten Witt had been in­ter­im med­ical chief since the ter­mi­na­tion of Rachel Humphrey in Au­gust 2021.

Lu­ca Sca­vo is out as CFO of Evelo Bio­sciences, ac­cord­ing to an 8-K fil­ing, leav­ing pres­i­dent and CEO Sim­ba Gill to take over his re­spon­si­bil­i­ties un­til the va­can­cy is filled. Sca­vo will “pur­sue an­oth­er pro­fes­sion­al op­por­tu­ni­ty” a year af­ter leav­ing his CFO post at Roche Di­ag­nos­tics North Amer­i­ca to join Evelo.

Cam Gal­lagher

→ Not to be con­fused with the Kansas City Roy­als’ back­up catch­er, Zen­tal­is co-founder and board mem­ber Cam Gal­lagher has been pro­mot­ed to pres­i­dent as new chief ex­ec­u­tive Kim Black­well set­tles in. For the last six years, Gal­lagher has been CBO of Take­da part­ner Im­mu­soft, and he’s al­so the for­mer head of cor­po­rate de­vel­op­ment at Onc­ter­nal Ther­a­peu­tics. Zen­tal­is al­so boost­ed its cof­fers with a $200 mil­lion raise as Black­well re­placed An­tho­ny Sun as CEO a cou­ple weeks ago.

David Kendall

Trum­pet­ing pos­i­tive Phase III da­ta for dasiglucagon in chil­dren with con­gen­i­tal hy­per­in­sulin­ism be­tween 7 days and 12 months of age, Zealand Phar­ma has pegged Eli Lil­ly alum David Kendall as CMO. Kendall, who had been a se­nior glob­al med­ical ad­vi­sor for Zealand, is for­mer­ly the CMO of MannKind and the VP, glob­al med­ical af­fairs for Lil­ly Di­a­betes. Dasiglucagon was ap­proved for di­a­betes pa­tients with se­vere hy­po­glycemia in March 2021 and is mar­ket­ed as Ze­ga­logue.

→ Big Phar­ma alum Neely Mozaf­far­i­an has made her way to Gen­tiBio as CMO, with the biotech try­ing to make some hay in the Treg space with such com­peti­tors as Jeff Blue­stone’s Sono­ma, TRexBio and Aba­ta Ther­a­peu­tics. Mozaf­far­i­an has held se­nior lead­er­ship roles in clin­i­cal de­vel­op­ment at Ab­b­Vie, Eli Lil­ly and Gilead, and she spent the last year as VP, im­munol­o­gy with J&J’s Janssen. Af­ter launch­ing in Au­gust 2020 with a $20 mil­lion seed round, Gen­tiBio raced to a $157 mil­lion Se­ries A one year lat­er.

Bri­an Roberts

→ At Re­zo­lute, a Sil­i­con Val­ley biotech that raised $130 mil­lion af­ter post­ing pos­i­tive Phase II da­ta for its con­gen­i­tal hy­per­in­sulin­ism drug in ear­ly May, Bri­an Roberts has been pro­mot­ed from head of clin­i­cal de­vel­op­ment to CMO. Roberts was part of the found­ing man­age­ment team at Re­zo­lute and be­came VP of clin­i­cal de­vel­op­ment in 2017. Ear­li­er, Roberts worked in clin­i­cal de­vel­op­ment at CymaBay and Fi­bro­Gen.

Ankur Dhin­gra

Ankur Dhin­gra has joined Bob Dug­gan’s crew at Sum­mit Ther­a­peu­tics as CFO. Af­ter 18 years and nu­mer­ous posts at Ag­i­lent Tech­nolo­gies, in­clud­ing VP of in­vestor re­la­tions, Dhin­gra joins Sum­mit from his first CFO gig at CareDx. In­vestors didn’t take too kind­ly to Sum­mit’s Phase III flop with its an­tibi­ot­ic for C. dif­fi­cile in­fec­tion in De­cem­ber 2021, and shares have con­tin­ued to tum­ble ever since.

Ker­ry Rus­sell

Ker­ry Rus­sell has joined Eli Lil­ly’s NASH part­ner Terns Phar­ma­ceu­ti­cals as CMO. Rus­sell’s most re­cent role was VP of late clin­i­cal de­vel­op­ment at Dicer­na Phar­ma­ceu­ti­cals, which was pur­chased by No­vo Nordisk in De­cem­ber 2021 for $3.3 bil­lion. She has al­so served as VP of clin­i­cal de­vel­op­ment at resTOR­bio and se­nior di­rec­tor of trans­la­tion­al car­dio­vas­cu­lar and meta­bol­ic med­i­cine at No­var­tis In­sti­tutes for Bio­med­ical Re­search.

→ Wa­ter­town, MA-based SQZ Biotech­nolo­gies, which showed pos­i­tive re­sults from its un­con­ven­tion­al cell ther­a­py man­u­fac­tur­ing tech in a non-clin­i­cal study last month, has ap­point­ed Marshelle Smith War­ren as CMO. Be­fore join­ing SQZ, War­ren was CMO and SVP of R&D at Virac­ta Ther­a­peu­tics. She has al­so held clin­i­cal de­vel­op­ment posts at AlloVir, Atara, Io­n­is, Gilead, Am­gen, and As­traZeneca.

Shilpi Aro­ra

→ Bio­mol­e­c­u­lar con­den­sate play­er Tran­si­tion Bio gath­ered up $50 mil­lion in Se­ries A fi­nanc­ing this week while al­so ap­point­ing Shilpi Aro­ra as SVP of dis­cov­ery re­search. Aro­ra comes to Tran­si­tion Bio from Exo Ther­a­peu­tics, where she was VP of dis­cov­ery and trans­la­tion­al bi­ol­o­gy. Voy­ager CEO and for­mer Bio­gen ex­ec Al San­drock makes an­oth­er Peer Re­view ap­pear­ance as a new mem­ber of the board of di­rec­tors at Tran­si­tion Bio, which al­so wel­comes Shaan Gand­hi of North­pond Ven­tures to the board.

→ For­mer Atara pres­i­dent and CEO Isaac Ciechanover is hop­ping aboard as a new part­ner at Qim­ing Ven­ture Part­ners USA — right as the firm clos­es its third fund, rais­ing $260 mil­lion. Most re­cent­ly, Ciechanover served as a part­ner at Po­laris Ven­ture Part­ners and ear­li­er in his ca­reer was with Cel­gene, where he helped dri­ve trans­ac­tions with com­pa­nies such as Ac­celeron, Ar­ray and PTC Ther­a­peu­tics.

Jamie Dona­dio

→ Texas-based Renibus Ther­a­peu­tics has sad­dled on Jamie Dona­dio as CFO and Bhupin­der Singh as CMO. Dona­dio joins the com­pa­ny from Bio­th­eryx, where he served in the same role of CFO. Pri­or to that, Dona­dio was SVP, CFO at Mi­rati Ther­a­peu­tics and se­nior di­rec­tor of fi­nance at Amylin Phar­ma­ceu­ti­cals. Singh is a clin­i­cal pro­fes­sor in the di­vi­sion of nephrol­o­gy at the Uni­ver­si­ty of Cal­i­for­nia, Irvine School of Med­i­cine and for­mer­ly served at ZS Phar­ma. Singh was al­so a founder of the South­west Kid­ney In­sti­tute.

→ Boston can­cer biotech Sen­sei Bio­ther­a­peu­tics, which raised $133 mil­lion dur­ing an IPO boom that seems like eons ago, has tapped Patrick Gal­lagher as CBO. Most re­cent­ly, Gal­lagher was man­ag­ing di­rec­tor of Bin­ney Street Part­ners, and the Ab­b­Vie vet has al­so served as head of cor­po­rate de­vel­op­ment & op­er­a­tions at Nu­va­tion Bio.

Kr­ish­na Al­lam­neni

→ The p27-fo­cused biotech Con­car­lo out of Brook­lyn makes its Peer Re­view de­but with Kr­ish­na Al­lam­neni as chief de­vel­op­ment of­fi­cer. An ex-sci­en­tist at Genen­tech/Roche and a for­mer ex­ec­u­tive di­rec­tor, glob­al non­clin­i­cal R&D with Jazz Phar­ma­ceu­ti­cals, Al­lam­neni was pre­vi­ous­ly VP, de­vel­op­ment sci­ences for Turn­ing Point Ther­a­peu­tics.

Richard Sain­son

Richard Sain­son is start­ing up a brand new day as CSO of STipe Ther­a­peu­tics, a Dan­ish biotech fo­cused on the STING path­way. Sain­son most re­cent­ly served as VP in trans­la­tion­al de­vel­op­ment at F-star Ther­a­peu­tics, and pri­or to that, he was se­nior di­rec­tor, trans­la­tion­al med­i­cine at Kymab.

→ The Cen­ter of Break­through Med­i­cines is bring­ing in Joseph Lin­gle as chief peo­ple of­fi­cer. Pri­or to mak­ing his way over to CBM, Lin­gle had a stint at Bris­tol My­ers, sup­port­ing the com­mer­cial­iza­tion and sup­ply for CAR-T as­sets Abec­ma and Breyanzi. Pri­or to that, Lin­gle had a near­ly 7-year run at No­var­tis and a near­ly 9-year gig at GSK.

Tom Pulles

Tom Pulles has signed on to be CMO of Dutch mi­to­chon­dr­i­al dis­ease out­fit Khon­dri­on. Pulles had a se­ries of roles at Shire be­fore piv­ot­ing to Ul­tragenyx in 2016 as head of pa­tient ad­vo­ca­cy, Eu­rope, even­tu­al­ly work­ing his way up to head of med­ical af­fairs, EMEA.

Michael Huang

→ Hop­ing to push one of its lead can­di­dates for re­tini­tis pig­men­tosa in­to the clin­ic this year, RA Cap­i­tal-backed DTx Phar­ma has brought on Michael Huang as CMO. Huang is the ex-med­ical chief of Am­Max Bio and Spruce Bio­sciences, and he’s been the VP, clin­i­cal de­vel­op­ment for Reg­u­lus Ther­a­peu­tics.

→ While we’ve got Reg­u­lus on our mind, the mi­croR­NA out­fit has se­lect­ed Amin Kamel as VP, drug me­tab­o­lism and phar­ma­co­ki­net­ics (DMPK). A one-time prin­ci­pal in­ves­ti­ga­tor at Bio­gen, Kamel was Take­da’s sci­en­tif­ic di­rec­tor of glob­al DMPK.

Leslie Auld

→ Cana­di­an Tetra Bio-Phar­ma, which spe­cial­izes in cannabi­noid-de­rived drug dis­cov­ery and de­vel­op­ment, is reel­ing in Leslie Auld as CFO. Auld pre­vi­ous­ly served as SVP and CFO of Aeter­na Zen­taris and has had stints at Gene­News, Atwell Cap­i­tal, Lu­minex Di­ag­nos­tics and He­lix Bio­phar­ma.

→ Boston-based Er­bi Biosys­tems has plucked up Brad Hamil­ton as CSO. Hamil­ton joins with ex­pe­ri­ence from Good­Cell (CSO) and Re­pro­CELL (chief tech­nol­o­gy of­fi­cer) un­der his belt. Pri­or to those roles, Hamil­ton was with Stem­gent, Rheo­Gene and Up­state Biotech.

Mar­cy Gra­ham

→ Now lead­ing Aa­di Bio­science af­ter help­ing in­vent Abrax­ane, Neil De­sai has poached Mar­cy Gra­ham from Po­sei­da as Aa­di names her SVP, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Gra­ham spent the last four years at Po­sei­da and was the CAR-T biotech’s VP of cor­po­rate af­fairs. She’s al­so been SVP, IR and cor­po­rate com­mu­ni­ca­tions with Mi­rati and aTyr Phar­ma.

Gary Ziez­i­u­la

→ Chi­na’s In­novent Bi­o­log­ics, which struck a deal with Tillman Gern­gross’ lat­est com­pa­ny Am­ag­ma Ther­a­peu­tics in Jan­u­ary, is tap­ping Gary Ziez­i­u­la as in­de­pen­dent non-ex­ec­u­tive di­rec­tor of the com­pa­ny’s board of di­rec­tors. Ziez­i­u­la cur­rent­ly serves as pres­i­dent of Ky­owa Kirin USA and pre­vi­ous­ly served as CCO and pres­i­dent of EMD Serono. Ad­di­tion­al­ly, Ziez­i­u­la has had stints at AM­AG, Roche, Bris­tol My­ers and Mer­ck.

Christo­pher Wright

Christo­pher Wright has joined the board of di­rec­tors at Alk­er­mes as Nan­cy Wysen­s­ki be­comes lead in­de­pen­dent di­rec­tor af­ter the Irish biotech’s an­nu­al meet­ing. Wright, the ex-de­vel­op­ment chief at Iron­wood, is the CMO for Bo Cum­bo’s squad at Aa­van­tiBio. The reshuf­fling of the Alk­er­mes board con­tin­ues with the re­tire­ments of David Anstice and Wendy Dixon “as part of the Board’s con­tin­ued re­fresh­ment process,” ac­cord­ing to the re­lease.

→ Ex-Boehringer In­gel­heim CEO Mar­ty Car­roll has been elect­ed to the board of di­rec­tors at Es­pe­ri­on, which ap­point­ed Stephen Ro­cam­boli to the board last month. Af­ter 25 years with Mer­ck, Car­roll helmed Boehringer In­gel­heim from 2003-11.

David Whead­on

Chemo­Cen­tryx has added David Whead­on to its board of di­rec­tors as Hen­ry McK­in­nell re­tires. In 2019, Whead­on re­tired from As­traZeneca as SVP, glob­al reg­u­la­to­ry af­fairs, pa­tient safe­ty and qual­i­ty as­sur­ance. He al­so sits on the boards of Vaxart, Karuna Ther­a­peu­tics and Sotera Health.

Michael Samar has a seat re­served on the board of di­rec­tors at an­ti-ag­ing play­er Uni­ty Biotech­nol­o­gy, which sliced its work­force in half ear­li­er this year with 34 jobs af­fect­ed. Samar was pro­mot­ed from SVP of fi­nance and busi­ness op­er­a­tions to CFO of As­sem­bly Bio­sciences in Au­gust 2021.

Melin­da Brown

→ A week af­ter Pre­ci­sion Bio­Sciences named Juli Blanche chief peo­ple of­fi­cer, they’re at it again in Peer Re­view, mak­ing room for Melin­da Brown on the board of di­rec­tors. Brown, who re­tired from Ta­pes­try in 2019 as SVP and con­troller, de­vot­ed 30 years to Pep­si­Co, leav­ing the megabrand as SVP, glob­al fi­nan­cial shared ser­vices and pro­duc­tiv­i­ty.

→ French vac­cine com­pa­ny Val­ne­va is adding Thomas Deck­er and Michael Pflei­der­er to its sci­en­tif­ic ad­vi­so­ry board. Deck­er is a pro­fes­sor of im­muno­bi­ol­o­gy at the Max Pe­rutz Labs of the Uni­ver­si­ty of Vi­en­na and is the cur­rent pres­i­dent of the Eu­ro­pean Macrophage and Den­drit­ic Cell So­ci­ety. Mean­while, Pflei­der­er has served as the head of the hu­man vi­ral vac­cines sec­tion at the Paul-Ehrlich-In­sti­tut, Ger­man Fed­er­al In­sti­tut for Vac­cines and Bio­med­i­cines since 1998.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).