Two Au­rinia ex­ecs are out — and CRISPR’s op­er­a­tions chief is­n't far be­hind; Bio­gen MS leader jumps to Eli Lil­ly part­ner

Robert Huizin­ga

Ac­cord­ing to an SEC fil­ing, Au­rinia’s EVP of re­search Robert Huizin­ga and CMO Neil Solomons are both walk­ing away by Hal­loween, and while no ex­pla­na­tions are giv­en, de­tails of their sev­er­ance pack­ages were pro­vid­ed. Huizin­ga had spent the last nine years at Au­rinia af­ter the Isotech­ni­ka merg­er: first as VP, clin­i­cal af­fairs, then as EVP, cor­po­rate de­vel­op­ment be­fore his lat­est pro­mo­tion in 2020. Solomons co-found­ed Au­rinia a decade ago and used to be VP of R&D with Vi­for Phar­ma. The Pe­ter Green­leaf-led Au­rinia just launched its “Get Un­com­fort­able” ad cam­paign, urg­ing lu­pus nephri­tis pa­tients to sched­ule check­ups with their doc­tor.

Lawrence Klein

CRISPR Ther­a­peu­tics COO Lawrence Klein will not re­turn next year “to pur­sue ex­ter­nal op­por­tu­ni­ties,” but he’ll stay un­til this year draws to a close. Klein was orig­i­nal­ly ap­point­ed VP, strat­e­gy in Feb­ru­ary 2016, even­tu­al­ly re­ceiv­ing pro­mo­tions to CBO in 2019 and COO a year lat­er. The search be­gins for a re­place­ment as CRISPR and Ver­tex make their case to the FDA for exa-cel, a once-and-done treat­ment for sick­le cell dis­ease and trans­fu­sion-de­pen­dent be­ta-tha­lassemia, af­ter get­ting lapped by blue­bird bio with Zyn­te­glo.

Nathalie Franchi­mont

→ Pair­ing up with Eli Lil­ly on AMPK ac­ti­va­tors a cou­ple of weeks ago in a deal that al­most reach­es the $500 mil­lion mark, Nim­bus Ther­a­peu­tics has poached Nathalie Franchi­mont from Bio­gen, nam­ing her CMO. Franchi­mont had re­cent­ly led the mul­ti­ple scle­ro­sis and im­munol­o­gy de­vel­op­ment unit and she held a cor­nu­copia of oth­er po­si­tions in her 10 years with Bio­gen, which is pin­ning its Alzheimer’s hopes on lecanemab af­ter the Aduhelm de­ba­cle. At Am­gen, she worked in med­ical af­fairs and clin­i­cal de­vel­op­ment, specif­i­cal­ly with the bone drug deno­sum­ab (now mar­ket­ed as Xge­va and Pro­lia).

Serge Stankovic

Serge Stankovic is set to re­tire as pres­i­dent of Aca­dia Phar­ma­ceu­ti­cals at the end of the year. A for­mer clin­i­cal de­vel­op­ment ex­ec with Te­va and Alk­er­mes, Stankovic was named head of R&D at Aca­dia in 2015 and pres­i­dent in 2018, help­ing guide the San Diego biotech to its on­ly ap­proved drug in April 2016. The FDA gave the OK to Nu­plazid for Parkin­son’s dis­ease psy­chosis, but Aca­dia’s been shoot­ing bricks late­ly in oth­er in­di­ca­tions, with CRLs in back-to-back years for de­men­tia- and Alzheimer’s-re­lat­ed psy­chosis. Up­on his re­tire­ment, Stankovic will move in­to a part-time ad­vi­so­ry role.

Ar­turo Moli­na

Ar­turo Moli­na’s time is wind­ing down as CMO of an­ti­body-drug con­ju­gate de­vel­op­er Sutro Bio­phar­ma, and Peer Re­view will keep its eyes peeled for his next des­ti­na­tion af­ter he leaves on Nov. 4. Sutro CEO Bill Newell will stand in for him un­til a per­ma­nent suc­ces­sor is found. Moli­na was VP of on­col­o­gy sci­en­tif­ic in­no­va­tion at J&J’s Cal­i­for­nia In­no­va­tion Cen­ter be­fore he joined Sutro, which struck an ADC deal with Astel­las for $90 mil­lion up­front in late June.

Dave Hap­pel

→ As biotech stocks were go­ing sub­ter­ranean, it dawned on Sagimet Bio­sciences that an IPO wasn’t pru­dent for them in March. This week there’s a new sher­iff in town at the NASH-cen­tered biotech, with Dave Hap­pel tak­ing over for George Kem­ble as chief ex­ec­u­tive. Since 2020, Hap­pel had been pres­i­dent and CEO of Cog­noa, and in an ear­li­er role, he was EVP of com­mer­cial de­vel­op­ment and strat­e­gy for Hori­zon. With Hap­pel in place, Kem­ble is slid­ing in­to the role of ex­ec­u­tive chair­man, suc­ceed­ing West­lake Vil­lage BioPart­ners man­ag­ing di­rec­tor Beth Sei­den­berg.

Robert Williamson

→ It didn’t take long for ex-Bio­th­eryx chief Robert Williamson to find his next gig, land­ing at T cell-fo­cused Tri­umvi­ra Im­muno­log­ics as pres­i­dent and CBO. Williamson was at the con­trols for Bio­th­eryx when the pro­tein degra­da­tion squad gar­nered a $92 mil­lion Se­ries E round in May 2021, and as we told you, he then be­came chief busi­ness and fi­nan­cial of­fi­cer at On­coMyx in March. Tri­umvi­ra says it’s con­struct­ing a new cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty in South San Fran­cis­co for its lead pro­gram, TAC01-HER2, that should open by next year.

Patrick Finn

→ Let’s Twist again: Patrick Finn has been pro­mot­ed to pres­i­dent and COO of DNA syn­the­sis heavy­weight Twist Bio­science, which inked a $710 mil­lion an­ti­body dis­cov­ery deal with Boehringer In­gel­heim last year. Finn signed on as Twist’s SVP, com­mer­cial op­er­a­tions in Feb­ru­ary 2015 and was el­e­vat­ed to chief com­mer­cial of­fi­cer in 2019. He’s al­so been VP of sales and mar­ket­ing for En­zy­mat­ics, now known as Qi­a­gen.

Sunitha Lak­sh­mi­narayanan

Po­si­tions are get­ting filled left and right at an­ti­body ra­di­a­tion-con­ju­gate (ARC) play­er Ac­tini­um: Jen­ny Hsieh (chief strat­e­gy of­fi­cer) was head of cor­po­rate strat­e­gy and op­er­a­tions with Im­munomedics as it was be­ing sold to Gilead for $21 bil­lion. In March, the large phar­ma hand­ed out pink slips to 114 staffers that worked out of Im­munomedics’ old HQ in Mor­ris Plains, NJ; Sunitha Lak­sh­mi­narayanan (head of CMC and prod­uct de­vel­op­ment) pre­vi­ous­ly took on the role of ex­ec­u­tive di­rec­tor, cell ther­a­py process en­gi­neer­ing at Bris­tol My­ers Squibb; Stephen Dres­sel (VP, strate­gic fi­nance and analy­sis) had a 10-year ca­reer at Re­gen­eron and just spent a year and a half with Dew­point Ther­a­peu­tics as se­nior di­rec­tor, fi­nan­cial plan­ning & analy­sis; Pe­ter Bak­er (di­rec­tor, drug sub­stance/drug prod­ucts op­er­a­tions) helped man­u­fac­ture Lu­tathera and Plu­vic­to as head of pro­duc­tion at No­var­tisAd­vanced Ac­cel­er­a­tor Ap­pli­ca­tions; and Mic­ah Riskin (di­rec­tor, prod­uct stew­ard, man­u­fac­tur­ing sci­ences & tech­nol­o­gy) has Bris­tol My­ers ties and re­cent­ly led process de­vel­op­ment and MSAT for Im­vax.

But wait, there’s more: Ac­tini­um has plucked Akash Na­har (VP, clin­i­cal de­vel­op­ment) from Mer­ck, where he served as glob­al prod­uct de­vel­op­ment lead for hema­tol­ogy; Elaina Haeu­ber (VP, head of clin­i­cal op­er­a­tions) is a vet­er­an of Sy­neos Health who had been VP of op­er­a­tions at WCG un­til May; fi­nal­ly, Mad­huri Vusirikala (VP, clin­i­cal de­vel­op­ment, bone mar­row trans­plant and cel­lu­lar ther­a­py) and Pa­trik Brodin (VP, head of ra­di­a­tion sci­ences) round out the hir­ing bo­nan­za.

Tim Mor­ris

Cameron Dur­rant will be on the look­out for an­oth­er COO and CFO as Tim Mor­ris de­camps from both posts at Hu­mani­gen and be­comes fi­nance chief at Opthea, a reti­nal dis­ease biotech that will be all set fi­nan­cial­ly for the time be­ing with $170 mil­lion in fund­ing through Car­lyle and Abing­worth’s Launch Ther­a­peu­tics and an ad­di­tion­al $90 mil­lion pri­vate place­ment. The ex-CFO of Io­vance and Acel­Rx just took an­oth­er board seat at Aque­s­tive Ther­a­peu­tics over the sum­mer.

→ As they build a plan around WHIM syn­drome drug ma­vorix­afor, X4 Phar­ma­ceu­ti­cals has re­cruit­ed Mark Baldry as chief com­mer­cial of­fi­cer. A for­mer com­mer­cial ex­ec at Shire, Bio­gen and Am­i­cus, Baldry has held this same post at Wave Life Sci­ences and Free­line Ther­a­peu­tics. The highs haven’t out­weighed the lows this year at X4, scor­ing a $55 mil­lion PIPE but cut­ting 20% of its staff and prun­ing the pipeline.

Al­i­son Long

→ There’s a batch of new ex­ecs at Anokion, while the Swiss au­toim­mune biotech al­so says that Stephan Kon­tos will re­lin­quish his CSO du­ties to chair the sci­en­tif­ic ad­vi­so­ry board. Al­i­son Long (CMO) once led clin­i­cal R&D at Spark and had been the med­ical chief with now-de­funct Kalei­do Bio­Sciences; Glenn Booma (chief strat­e­gy of­fi­cer) is a Gen­zyme alum who had worked as a life sci­ences con­sul­tant for the past nine years; and Stephanie Haller (SVP, clin­i­cal op­er­a­tions) on­ly needs to re­place three let­ters on her busi­ness card af­ter part­ing ways with Alex­ion, where she was se­nior di­rec­tor, clin­i­cal op­er­a­tions, ther­a­peu­tic area lead, nephrol­o­gy. Ad­di­tion­al­ly, Anokion pro­mot­ed Kristie Grebe from VP, clin­i­cal & trans­la­tion­al de­vel­op­ment to SVP, im­munol­o­gy & trans­la­tion­al med­i­cine. Pfiz­er in­vest­ed $35 mil­lion in­to Anokion’s celi­ac dis­ease ther­a­py KAN-101 last week.

→ The gly­co­pro­teomics spe­cial­ists at In­ter­Venn Bio­sciences have pro­mot­ed Er­win Es­ti­gar­rib­ia to pres­i­dent and COO. Es­ti­gar­rib­ia brought plen­ty of di­ag­nos­tics ex­pe­ri­ence be­fore com­ing to In­ter­Venn in 2019, with stints as an op­er­a­tions ex­ec at Car­dioDx and Ap­plied Pro­teomics — and fur­ther back, he had a se­ries of lead­er­ship roles with Ch­i­ron, No­var­tis and Geron.

Ed­ward Kim

→ We have all sorts of oth­er CMO ap­point­ments to dis­cuss, and Ed­ward Kim is first up at Swedish men­tal ill­ness and ad­dic­tion dis­or­der biotech Orexo. Kim steps away from Bio­haven, where he was head of med­ical af­fairs, and he’s a No­var­tis neu­ro alum who has fur­ther Big Phar­ma con­nec­tions as the for­mer schiz­o­phre­nia ther­a­peu­tic area leader at J&J’s Janssen.

PaxMed­ica’s mod­est IPO may have been un­der the radar a cou­ple months ago, but the New York biotech has added some grav­i­tas to the staff with Big Phar­ma alum Ste­fan Schwabe as CMO. Schwabe spent more than a decade in neu­ro roles at J&J, No­var­tis and Sanofi, and since 2012 he had been CMO and EVP of R&D at Su­per­nus, get­ting out of Dodge not long af­ter the FDA threw cold wa­ter on the lat­est pitch for its Parkin­son’s drug SPN-830 ear­li­er this month. PaxMed­ica is ad­vanc­ing its lead as­set PAX-101 (in­tra­venous suramin) in autism spec­trum dis­or­der, with a pre­clin­i­cal study of the drug in the works for Frag­ile X-as­so­ci­at­ed tremor/atax­ia syn­drome (FX­TAS).

Mark Deeg

Mark Deeg has been named med­ical chief at Enve­da Bio­sciences, a Boul­der, CO start­up that chalked up the cash with a $51 mil­lion Se­ries A in June 2021. Deeg was once the chief med­ical and safe­ty of­fi­cer for Eli Lil­ly’s Cho­rus in his 10 years with the In­di­anapo­lis phar­ma, and the ex-Reg­u­lus CMO re­cent­ly over­saw glob­al clin­i­cal de­vel­op­ment at Cull­gen. Else­where, Deeg earned a pro­mo­tion to VP of R&D at Pear Ther­a­peu­tics be­fore tak­ing the Cull­gen job last year.

→ As Rob Thom­son shed the in­ter­im la­bel this sea­son and is now bound for the World Se­ries as man­ag­er of the Philadel­phia Phillies, will we say the same some­day for in­ter­im CMO Richard Gray­don’s job sta­tus at Seat­tle breast can­cer biotech Atossa Ther­a­peu­tics? Gray­don worked on such drugs as Carvyk­ti (cil­ta-cel) and Im­bru­vi­ca as the se­nior di­rec­tor of clin­i­cal de­vel­op­ment for Janssen, and he has served as di­rec­tor of clin­i­cal de­vel­op­ment at Dai­ichi Sankyo.

Jens Würth­n­er has jumped on board as CMO of Am­s­ter­dam’s Scenic Biotech, which al­lied with Roche two years ago in a de­vel­op­ment deal in­volv­ing ge­net­ic mod­i­fiers and raised $31 mil­lion in March. Würth­n­er’s Big Phar­ma back­ground in­cludes stops at As­traZeneca, GSK and as a clin­i­cal pro­gram leader at No­var­tis be­fore piv­ot­ing to ADC Ther­a­peu­tics in 2016. He had led glob­al clin­i­cal de­vel­op­ment at ADC since Jan­u­ary 2020.

Ed­ward Fang

→ To close this CMO loop, an­timi­cro­bial de­vel­op­er Adap­tive Phage Ther­a­peu­tics has tapped Ed­ward Fang for the po­si­tion. Fang has held this post be­fore at Ade­ni­um Biotech and US-Chi­na out­fit Mi­cuRx Phar­ma­ceu­ti­cals. In April, Adap­tive Phage topped off the cash tank from its Se­ries B from May 2021 to bring the to­tal to $61 mil­lion, and the fol­low­ing month it be­gan the Phase I/II tri­al for its di­a­bet­ic foot os­teomyelitis treat­ment.

Avi­va As­nis-Al­i­bozek

→ Ex-An­tios chief Greg Mayes is shoring up his lead­er­ship at Toron­to psy­che­delics play­er Re­union Neu­ro­science with Ed­ward Smith as CFO and Avi­va As­nis-Al­i­bozek as VP, med­ical af­fairs. Smith has held a string of CFO posts at La­va Ther­a­peu­tics, Mar­i­nus Phar­ma­ceu­ti­cals and Poly­Medix, and he’s a board mem­ber at Ben­itec Bio­phar­ma. A one-time med­ical af­fairs di­rec­tor at As­traZeneca, As­nis-Al­i­bozek was EVP of med­ical af­fairs dur­ing her six years at TRM On­col­o­gy.

Travis May’s health­care in­for­ma­tion up­start Data­vant — a rel­a­tive in the Vivek Ra­maswamy fam­i­ly of “vants” — has crunched the num­bers and se­lect­ed Mar­la Kessler as chief mar­ket­ing of­fi­cer. The Pfiz­er mar­ket­ing vet fol­lowed up her 13 years at IQVIA with a re­cent year­long stay at Ae­tion as chief cus­tomer of­fi­cer.

Di­ane Gomez-Thinnes

Things can on­ly get Bet­ter: J&J alum Di­ane Gomez-Thinnes has joined San Fran­cis­co-based Bet­ter Ther­a­peu­tics as chief com­mer­cial of­fi­cer. Last year, Gomez-Thinnes fin­ished her 17-year tenure at J&J as the world­wide pres­i­dent of its medtech Men­tor, and from there she be­came the pres­i­dent of US op­er­a­tions for Gal­der­ma.

Klean­this Xan­thopou­los’ cell ther­a­py crew at Shore­line Bio­sciences has wel­comed Charles Calder­aro III as chief tech­ni­cal of­fi­cer. Calder­aro knows his way around the space from his days at Kite, where he was in charge of CAR-T man­u­fac­tur­ing as glob­al head of tech­ni­cal op­er­a­tions. Af­ter sev­er­al lead­er­ship po­si­tions in a 14-year pe­ri­od at Genen­tech, Calder­aro moved on to Bio­Marin as SVP, glob­al man­u­fac­tur­ing from 2016-19.

Ja­son Apter

→ CRO San­no­va An­a­lyt­i­cal has sad­dled up Ja­son Apter as CEO and Stephen Unger as CFO. This isn’t Apter’s first time run­ning things in the CEO seat, hav­ing called the shots pre­vi­ous­ly as CEO at John­son Matthey’s health di­vi­sion. Apter al­so has ex­pe­ri­ence un­der his belt from Mil­li­pore Sig­ma and Sig­ma-Aldrich. Mean­while, Unger hops aboard af­ter a stint as CFO at Quo­tient and Cir­cu­lo­gene Ther­a­nos­tics.

Genuv has named Jen­ny Choih pres­i­dent of its new Cam­bridge, MA-based sub­sidiary Genuv US. Choih joined Genuv in 2016, most re­cent­ly serv­ing as di­rec­tor of de­vel­op­ment. Ear­li­er in her ca­reer, Choih was a con­sul­tant at McK­in­sey.

John Leonard

In­tel­lia CEO John Leonard is join­ing the likes of Sean Park­er and John Con­nol­ly on the board of di­rec­tors at 3T Bio­sciences, a TCR start­up that pulled to­geth­er a $40 mil­lion Se­ries A led by chair­man Sean Harp­er and the folks at West­lake Vil­lage BioPart­ners. The Ab­bott and Ab­b­Vie alum is al­so a board mem­ber at IQVIA.

Chris­tine Lin­den­boom

→ As Re­don­da Miller ex­its from the board of di­rec­tors at In­vivyd, Chris­tine Lin­den­boom will step in dur­ing a time of tu­mult marked by last week’s lay­offs and ex­ec­u­tive de­par­tures af­ter Till­man Gern­gross bailed as CEO in Feb­ru­ary. An Am­gen and Pfiz­er vet, Lin­den­boom is Al­ny­lam’s SVP of in­vestor re­la­tions & cor­po­rate com­mu­ni­ca­tions.

→ Fred Hutch’s Tom Lynch has sewn up a spot on the board of di­rec­tors at Flag­ship’s Foghorn Ther­a­peu­tics. Lynch’s ap­point­ment comes af­ter the FDA threw down the stop sticks with a full clin­i­cal hold on Foghorn’s blood can­cer drug FHD-286 in Au­gust. A par­tial hold was hand­ed out a few months be­fore.

Ray­mond Kelle­her

Ex­pan­sion Ther­a­peu­tics has elect­ed Ray­mond Kelle­her to the board of di­rec­tors at a time when drug­ging RNA con­tin­ues to at­tract in­ter­est. Kelle­her, a fac­ul­ty mem­ber at Mass­a­chu­setts Gen­er­al Hos­pi­tal and Har­vard Med­ical School, is man­ag­ing di­rec­tor of Cor­morant As­set Man­age­ment.

Ubiquigent has an­nounced that the com­pa­ny’s CSO Shee­lagh Frame has joined its board of di­rec­tors. Frame be­gan her ca­reer at Ubiquigent in 2018 as head of bi­ol­o­gy be­fore be­ing pro­mot­ed to her cur­rent po­si­tion last year. Pri­or to this role, Frame was with Cy­cla­cel and Onyx Phar­ma­ceu­ti­cals.

TC Bio­pharm has fin­ished set­ting up its sci­en­tif­ic ad­vi­so­ry board, which now con­sists of: Blythe Sather (VP and head of re­search at Tune Ther­a­peu­tics), Erin Adams (pro­fes­sor at the Uni­ver­si­ty of Chica­go), Chris Bond (ex­pe­ri­ence from Genen­tech, On­coMed, Juno, Cel­gene and Kite), Is­abelle Riv­iere (di­rec­tor of the cell ther­a­py and cell en­gi­neer­ing lab­o­ra­to­ry at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter), Daniel Olive (re­searcher at the Can­cer Re­search Cen­ter of In­sti­tut Paoli-Cal­mettes), and Uma Lak­sh­mi­pa­thy (head of patheon trans­la­tion ser­vices and cell ther­a­py R&D phar­ma ser­vices group at Ther­mo Fish­er).

Trin­i­ty Biotech is adding a fresh face to its board of di­rec­tors as two oth­ers hit the ex­it. Tom Lind­say joins as non-ex­ec­u­tive di­rec­tor, hav­ing served pre­vi­ous­ly as pres­i­dent of Alere’s (now a part of Ab­bott) busi­ness in Africa and cur­rent­ly serves as a board mem­ber at Genedrive. At the same time, di­rec­tors Seon Kyu Jeon and Michael Sung Soo Kim are head­ing out the door.

Il­lus­tra­tion: Kim Ryu for End­points News

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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As you start planning for #JPM23, we hope you will consider joining Endpoints News for our live and virtual events. For those who are celebrating Thanksgiving, we hope you are enjoying the long weekend with loved ones. And if you’re not — we’ll see you next week!

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Alzheimer’s drug bites the dust; Re­struc­ture, re­struc­ture, re­struc­ture; Land­mark di­a­betes OK; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Being in the news business can give one a warped sense of time — it feels like quite a while since we published some of these stories below. But next Saturday’s Endpoints Weekly will definitely be shorter, as we take off Thursday and Friday for Thanksgiving. We will still have the abbreviated edition in your inbox at the usual time.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

The FDA typically releases guidance to help generic drug manufacturers develop new copycats of small molecule drugs, oftentimes in preparation for a brand name product’s patents or exclusivity to expire.

This week, FDA released such bioequivalence guidance for any generic drugmakers looking to take on Sarepta’s Duchenne muscular dystrophy (DMD) drug Exondys 51 (eteplirsen), even though the drug’s sponsor has yet to convert the accelerated approval to a full approval, showing clinical benefit.