As law­suit car­ries on against Guardant Health, CFO shake­up hits Il­lu­mi­na; Pfiz­er-backed biotech taps CEO to lead pur­suit of gene ther­a­py 2.0

Joy­deep Goswa­mi

Sam Samad is out as CFO of Il­lu­mi­na as chief strat­e­gy and cor­po­rate de­vel­op­ment of­fi­cer Joy­deep Goswa­mi slides in for him on an in­ter­im ba­sis start­ing Ju­ly 8. Goswa­mi joined Fran­cis deS­ouza’s crew in 2019 as SVP of cor­po­rate de­vel­op­ment and strate­gic plan­ning af­ter his time as pres­i­dent of Ther­mo Fish­er’s clin­i­cal next-gen­er­a­tion se­quenc­ing (NGS) and on­col­o­gy busi­ness unit.

Guardant Health, a pri­ma­ry liq­uid biop­sy screen­ing test com­peti­tor, filed a mo­tion to dis­miss Il­lu­mi­na’s case against the com­pa­ny in late May. Its co-founders and co-CEOs, Helmy El­toukhy and Ami­rAli Ta­lasaz, are for­mer staffers at Il­lu­mi­na, which is al­leg­ing that the pair in­fringed on in­tel­lec­tu­al prop­er­ty to de­vel­op Guardant’s tech­nol­o­gy.

“Il­lu­mi­na’s law­suit friv­o­lous­ly chal­lenges our own­er­ship and au­thor­ship of our in­tel­lec­tu­al prop­er­ty, which is the back­bone of our vi­tal work,” Guardant Health gen­er­al coun­sel John Sa­ia said in a March state­ment.

→ Swiss gene ther­a­py play­er An­jar­i­um Bio­sciences jumped in­to the gene ther­a­py 2.0 fray with a Se­ries A in Sep­tem­ber 2021 that fea­tured con­tri­bu­tions from Abing­worth, Gimv and Pfiz­er’s ven­ture arm, and this week Stephen Yoo has hitched a ride as CEO. Yoo held clin­i­cal de­vel­op­ment posts at Med­Im­mune/As­traZeneca be­fore tak­ing the CMO job at Re­genxbio, and since 2019 he was CMO and at Third Har­mon­ic Bio, a role present­ly oc­cu­pied by Ed­ward Con­ner.

Mar­tin Hu­ber

→ Mass­a­chu­setts sol­id tu­mor biotech Xilio Ther­a­peu­tics has pro­mot­ed Mar­tin Hu­ber to pres­i­dent of the com­pa­ny. Even with his new role, Hu­ber will still main­tain re­spon­si­bil­i­ties as pres­i­dent of R&D. Hu­ber joined Xilio af­ter a stint as SVP and CMO of Tesaro (ac­quired by GSK). Ear­li­er on in his ca­reer, Hu­ber was SVP, on­col­o­gy clin­i­cal re­search at Mer­ck and held roles at Scher­ing-Plough, Roche and Rhone-Poulenc Ror­er. Hu­ber cur­rent­ly sits on the boards of Mer­sana Ther­a­peu­tics and Syn­dax Phar­ma­ceu­ti­cals.

In ad­di­tion to Hu­ber’s pro­mo­tion, Xilio is pulling out some seats on its board for for­mer Alex­ion and Bio­gen CFO Paul Clan­cy as chair (suc­ceed­ing Dan Lynch, who is tran­si­tion­ing to strate­gic ad­vi­sor of the com­pa­ny) and Sur­face On­col­o­gy CEO Robert Ross.

David Gilman

→ With for­mer Rafael Hold­ings boss Ameet Mallik run­ning the show, ADC Ther­a­peu­tics has in­stalled David Gilman as chief busi­ness & strat­e­gy of­fi­cer. Gilman spent his short snip­pet of time at No­var­tis On­col­o­gy as glob­al head of port­fo­lio strat­e­gy and busi­ness de­vel­op­ment, over­lap­ping with Mallik’s run as head of US op­er­a­tions. Gilman even­tu­al­ly left No­var­tis in 2019 to be­come a part­ner at ClearView Health­care Part­ners.

An­drea Pirzkall

Replimune phased out An­drea Pirzkall’s po­si­tion in 2021 af­ter a year on the job “with­out cause,” but she has since resur­faced at San Fran­cis­co-based Ash­er Bio as CMO. Be­fore her stint at Replimune, Pirzkall was BeiGene’s ex­ec­u­tive di­rec­tor of clin­i­cal de­vel­op­ment and al­so spent a decade at Genen­tech. Ash­er Bio gar­nered the sup­port of Third Rock and RA Cap­i­tal with its $108 mil­lion Se­ries B last Sep­tem­ber as it de­vel­ops its lead can­di­date, a CD8-tar­get­ing IL-2.

Feng Ren

Alex Zha­voronkov’s glob­al AI play­er In­sil­i­co Med­i­cine — which days ago added a ro­bot­ics lab to the com­pa­ny with a fresh in­jec­tion of $60 mil­lionis bump­ing up their CMO Feng Ren in­to the role of co-CEO. Ren will be in charge of the de­vel­op­ment side of things as the com­pa­ny be­gins test­ing more of their drugs in hu­mans while Zha­voronkov will han­dle the AI por­tion of the com­pa­ny. Ren, a Har­vard grad, joined the com­pa­ny last Feb­ru­ary af­ter a stint in Shang­hai. Ear­li­er in his ca­reer, Ren spent 11 years with GSK R&D Chi­na, cul­mi­nat­ing in his role as head of chem­istry.

Kel­ley Deal­hoy

De­ci­phera sang the re­struc­tur­ing blues af­ter a late-stage tri­al fail with Qin­lock last fall, send­ing 35% of its work­force pack­ing in a move that CEO Steve Ho­ert­er hopes will keep the lights on through 2024. As they press for­ward, Big Phar­ma vet Kel­ley Deal­hoy has stepped in as CBO. In a to­tal of 10 years with No­var­tis, Deal­hoy held such roles as VP of US busi­ness de­vel­op­ment for the phar­ma­ceu­ti­cal di­vi­sion, glob­al head of busi­ness de­vel­op­ment and M&A for the con­sumer di­vi­sion, and more re­cent­ly, VP of busi­ness de­vel­op­ment for the on­col­o­gy di­vi­sion.

Col­in Mc­Crack­en

Col­in Mc­Crack­en is mo­sey­ing down to syn­thet­ic bio com­pa­ny Evonetix to take over the reins as CEO. Mc­Crack­en joins the Cam­bridge, UK-based com­pa­ny from Flu­idigm, where he served as SVP and CCO. Pri­or to that stint, Mc­Crack­en had gigs at Ther­mo Fish­er (VP and gen­er­al man­ag­er and VP of sales); Life Tech­nolo­gies (VP and head of Eu­ro­pean sales); and Qi­a­gen (na­tion­al sales man­ag­er).

The heat is on … and then it wasn’t, when Heat Bio re­brand­ed to NightHawk Bio­sciences in April. NightHawk has tapped Stephan Kutzer as in­ter­im CEO of its CD­MO sub­sidiary Scor­pi­on Bi­o­log­i­cal Ser­vices, which will be build­ing a new bio­man­u­fac­tur­ing site in the Lit­tle Ap­ple of Man­hat­tan, KS. Af­ter 18 years at Lon­za, 10 of those as pres­i­dent, di­vi­sion­al CEO and COO of the phar­ma biotech & cus­tomer man­u­fac­tur­ing di­vi­sion, Kutzer held the top spot at Al­ca­mi Cor­po­ra­tion, a com­pa­ny he al­so chaired.

Lar­isa Amir

Mer­ck KGaA is pro­mot­ing Lar­isa Amir to the role of man­ag­ing di­rec­tor of its health­care R&D cen­ter in Is­rael. Amir joined Mer­ck KGaA in 2009 and served in a num­ber of roles be­fore cul­mi­nat­ing in her last po­si­tion as glob­al head of prod­ucts qual­i­ty LCM. Amir is al­so a mem­ber of the Mer­ck Glob­al Health­care Dis­cov­ery Tech­nol­o­gy Lead­er­ship team. Pri­or to join­ing Mer­ck, Amir was COO at Procog­nia.

Melis­sa Brad­ford-Klug

→ On Ju­ly 1, Melis­sa Brad­ford-Klug will de­but as COO of Akari Ther­a­peu­tics, now helmed by for­mer En­zy­vant chief Rachelle Jacques. Brad­ford-Klug has worked in the rare dis­ease space for Greater Chi­na as pres­i­dent and CBO of Rare­Stone Group since Jan­u­ary 2020; the for­mer Mallinck­rodt and AM­AG Phar­ma­ceu­ti­cals vet has CEO ex­pe­ri­ence with Keryx Bio­phar­ma­ceu­ti­cals and women’s health-fo­cused May­field Phar­ma­ceu­ti­cals.

Sylvie Rycke­busch

→ Be­fore strik­ing a $25 mil­lion im­muno-on­col­o­gy deal with Ex­elix­is, Swe­den’s BioIn­vent named Sylvie Rycke­busch as CBO, div­ing in­to an ex­ec­u­tive po­si­tion af­ter as­sist­ing BioIn­vent part-time since 2019. In her 12 years at Mer­ck KGaA/EMD Serono, Rycke­busch was head of neu­rol­o­gy and au­toim­mune dis­ease li­cens­ing, busi­ness de­vel­op­ment. BioIn­vent al­so added For­bion’s Nan­na Lüneborg and Red­mile Group’s Na­tal­ie Bern­er to the board of di­rec­tors on Thurs­day, the same day the Ex­elix­is deal was an­nounced.

Svet­lana Makhni

→ TCR up­start Maren­go Ther­a­peu­tics al­ready added some grav­i­tas to the team with FDA and Sana vet Ke Liu’s ap­point­ment as chief de­vel­op­ment of­fi­cer, and it’s CFO Svet­lana Makhni who takes cen­ter stage a month lat­er. Makhni, the ex-fi­nance chief of Bier­man and Escient Phar­ma­ceu­ti­cals, cut her teeth at Black­stone, West­brook Part­ners, Gold­man Sachs and BMO Cap­i­tal Mar­kets. In No­vem­ber 2021, Ap­ple Tree Part­ners poured $80 mil­lion in­to cre­at­ing Maren­go, a biotech tak­ing aim at Vβ TCR vari­ants.

Xavier Leroy

Do­main Ther­a­peu­tics, the French-Cana­di­an GPCR play­er which bagged a $42 mil­lion Se­ries A back in May, has pro­mot­ed Xavier Leroy to CSO, who first joined the start­up back in 2019 as chief tech­nol­o­gy of­fi­cer. Leroy has al­so served as head of drug dis­cov­ery at iTeos Ther­a­peu­tics and owns GPCR ex­pe­ri­ence from his 13 years at Acte­lion.

He­man­shu Shah

→ Helsin­ki-based Va­lo Ther­a­peu­tics (not to be con­fused with Flag­ship’s Va­lo Health) has picked up He­man­shu Shah as CBO. Shah has Big Phar­ma ex­pe­ri­ence ga­lore from 13 years at Bris­tol My­ers Squibb and a year as J&J’s glob­al com­mer­cial leader, on­col­o­gy. From 2012-14, he was VP of glob­al mar­ket­ing and glob­al ther­a­peu­tic head for trans­plan­ta­tion, im­munol­o­gy & in­fec­tious dis­eases with Astel­las, and be­fore ac­cept­ing this role, Shah served as VP, cor­po­rate de­vel­op­ment at Trans­gene.

→ Hangzhou, Chi­na-based As­cle­tis — the first pre-rev­enue biotech to list on the HKEX in 2018 — has rolled out the wel­come mat for John Gargiu­lo as CBO. A key cog in the US busi­ness op­er­a­tions of Dai­ichi Sankyo, Gargiu­lo con­clud­ed his 18 years with As­traZeneca’s En­her­tu part­ner as North Amer­i­can pres­i­dent and CEO, and from there, he was a prin­ci­pal for GPG En­ter­pris­es.

Kei­th Goldan

Brig­gs Mor­ri­son did a switcheroo with Michael Met­zger at Syn­dax Phar­ma­ceu­ti­cals in Feb­ru­ary, as Mor­ri­son ced­ed his CEO post to Met­zger to take on the role of pres­i­dent and lead R&D. Against that back­drop, Syn­dax’s CFO va­can­cy has been filled by Kei­th Goldan, who leaves the same role at Opti­nose just as the biotech gained more trac­tion with its nasal spray Xhance for pa­tients with chron­ic si­nusi­tis in a sec­ond Phase III tri­al.

Adam Muzikant

At­tempt­ing to sep­a­rate it­self in a bur­geon­ing pro­tein degra­da­tion field, RA Cap­i­tal-backed Avi­lar Ther­a­peu­tics has in­tro­duced Adam Muzikant to the squad as CBO. Muzikant was at the ne­go­ti­at­ing ta­ble as busi­ness chief of Flex­ion Ther­a­peu­tics when the Zil­ret­ta mak­er was sold to Paci­ra Bio­sciences in Oc­to­ber 2021. Be­fore join­ing Flex­ion, Muzikant was a busi­ness de­vel­op­ment ex­ec with AM­AG Phar­ma­ceu­ti­cals and Syn­ta Phar­ma­ceu­ti­cals.

River­side Part­ners’ port­fo­lio com­pa­ny Syn­er-G Bio­Phar­ma Group is ush­er­ing in Ron Kraus as CEO, suc­ceed­ing Prabu Nam­biar. Kraus joins from Cy­tel, where he served as COO. Pri­or to that, Kraus spent two decades at Parex­el In­ter­na­tion­al in a va­ri­ety of roles in­clud­ing glob­al head of Parex­el Con­sult­ing.

Tan­moy Gan­gu­ly

→ Af­ter jump­ing on board as CEO of Gly­co­Era last month, Ganesh Kaun­dinya has shored up his lead­er­ship with a long­time col­league. Tan­moy Gan­gu­ly will take on CSO du­ties at the gly­co­bi­ol­o­gy and pro­tein degra­da­tion biotech, piv­ot­ing from Evelo Bio­sciences, where he was a VP in charge of phar­ma­col­o­gy, re­search an­a­lyt­ics and bioin­for­mat­ics. Gan­gu­ly spent a sig­nif­i­cant por­tion of his ca­reer at Mo­men­ta, which Kaun­dinya found­ed in 2001 and was sold to J&J in 2020 for $6.5 bil­lion.

Adar Makovs­ki Sil­ver­stein

Heavy no­va: There’s a pair of pro­mo­tions at New­town, PA can­cer biotech On­cono­va, as Mark Guerin (COO and CFO) and Adar Makovs­ki Sil­ver­stein (se­nior di­rec­tor and head of cor­po­rate de­vel­op­ment) climb the lad­der. Guerin tacks on an­oth­er role af­ter serv­ing as CFO of On­cono­va since Sep­tem­ber 2013, with the com­pa­ny’s $78 mil­lion IPO pre­dat­ing his ar­rival by two months. We cov­ered Sil­ver­stein’s ap­point­ment as di­rec­tor, cor­po­rate de­vel­op­ment last De­cem­ber af­ter her near­ly three years in busi­ness de­vel­op­ment, ex­ter­nal R&D at Am­gen.

Su­san Coul­tas

→ Eye dis­ease-fo­cused Clear­side Bio­med­ical has re­cruit­ed Su­san Coul­tas as chief clin­i­cal of­fi­cer. Coul­tas most re­cent­ly served as SVP of clin­i­cal de­vel­op­ment at Kala Phar­ma­ceu­ti­cals. Be­fore that, Coul­tas had gigs at Al­con Lab­o­ra­to­ries, CibaV­i­sion Oph­thalmics, Su­cam­po Phar­ma­ceu­ti­cals, Bausch + Lomb and In­fo­Quest Clin­i­cal Net­work.

→ Durham, NC-based Aera­mi Ther­a­peu­tics has ap­point­ed Lisa Yañez as COO. Be­fore join­ing the C-suite at Aera­mi, Yañez held ex­ec­u­tive po­si­tions at Ac­celeron (VP of glob­al strate­gic mar­ket­ing) and Unit­ed Ther­a­peu­tics (VP of mar­ket­ing, an­a­lyt­ics and train­ing). Ear­li­er, she was a prod­uct man­ag­er with GSK, Al­ler­gan and Genen­tech.

Katy Moore

→ Cary, NC-based Al­lu­cent has tapped Katy Moore as pres­i­dent of clin­i­cal phar­ma­col­o­gy, mod­el­ing and sim­u­la­tion. Moore joins with a wealth of ex­pe­ri­ence, hav­ing served as glob­al head of clin­i­cal phar­ma­col­o­gy at Vi­iV Health­care; head­ed the vi­ral dis­eases and on­col­o­gy clin­i­cal phar­ma­col­o­gy, mod­el­ing and sim­u­la­tion teams at GSK; and al­so led world­wide busi­ness de­vel­op­ment teams at GSK.

Philip Okala

Philip Okala has been named sys­tem pres­i­dent at City of Hope, fill­ing a cru­cial role at one of the na­tion’s lead­ing can­cer re­search cen­ters in Sep­tem­ber. Okala will run clin­i­cal care and re­search sites un­der the City of Hope um­brel­la, such as City of Hope Los An­ge­les, City of Hope Or­ange Coun­ty, Trans­la­tion­al Ge­nomics Re­search In­sti­tute (TGen), Beck­man Re­search In­sti­tute of City of Hope and Can­cer Treat­ment Cen­ters of Amer­i­ca. Okala comes to City to Hope af­ter five years as COO of the Uni­ver­si­ty of Penn­syl­va­nia Health Sys­tem.

Dag Nesse has been named di­rec­tor of clin­i­cal op­er­a­tions at Epi­En­do Phar­ma­ceu­ti­cals out of Reyk­javik, which raised a mod­est €20 mil­lion in its Se­ries A last sum­mer. Neese most re­cent­ly served as se­nior di­rec­tor, head of clin­i­cal op­er­a­tions at Cal­lid­i­tas Ther­a­peu­tics, and he has al­so served as head of op­er­a­tions at Modus Ther­a­peu­tics.

Vanes­sa Salazar

Vanes­sa Salazar has moved to Boston gene ther­a­py biotech STRM.BIO as VP of busi­ness de­vel­op­ment. Pri­or to join­ing STRM.BIO, she was ex­ec­u­tive di­rec­tor of cor­po­rate de­vel­op­ment and strate­gic part­ner­ships at Pas­sage Bio. Salazar, who start­ed her ca­reer with a 16-year run at GSK, was al­so cor­po­rate de­vel­op­ment lead at Spark Ther­a­peu­tics.

→ One day af­ter be­ing slapped with a Form 483 for mul­ti­ple pro­duc­tion is­sues, Ger­man CD­MO Rentschler Bio­phar­ma is wel­com­ing aboard Kas­sim Ko­lia as VP, busi­ness de­vel­op­ment. Ko­lia comes aboard boast­ing ex­pe­ri­ence from Fin­Vec­tor & Oy, Eden Biode­sign/Al­ler­gan, Lon­za and Ap­tu­it (part of Evotec).

Deep­ak Bhatt

→ Bris­tol My­ers has ex­pand­ed its board of di­rec­tors, ap­point­ing Deep­ak Bhatt to the board’s Sci­ence & Tech­nol­o­gy Com­mit­tee. For­mer­ly with the Cleve­land Clin­ic and VA Boston Health­care, Bhatt is the ex­ec­u­tive di­rec­tor of in­ter­ven­tion­al car­dio­vas­cu­lar pro­grams at Brigham and Women’s Hos­pi­tal.

Mike Huck­man

→ Dur­ing this week’s con­ven­tion in San Diego, BIO dipped in­to the com­mu­ni­ca­tions realm to ap­point Mike Huck­man to the board of di­rec­tors. A three-time Em­my win­ner, Huck­man spent 10 years as the phar­ma­ceu­ti­cals re­porter at CN­BC and is now glob­al prac­tice leader for ex­ec­u­tive com­mu­ni­ca­tions at Re­al Chem­istry.

Verve Ther­a­peu­tics, which just last month be­came the third biotech — be­hind In­tel­lia and Ed­i­tas Med­i­cine — to test its gene edit­ing tech­nol­o­gy in hu­mans, has made way for Bo Cum­bo on its board of di­rec­tors. Cum­bo, the ex-Sarep­ta chief com­mer­cial of­fi­cer, cur­rent­ly serves as pres­i­dent and CEO of Aa­van­tiBio.

Wendy Dixon

→ You may re­call that Wendy Dixon re­tired from Alk­er­mes’ board of di­rec­tors in what the biotech called a“con­tin­ued re­fresh­ment process,” but an­oth­er op­por­tu­ni­ty has opened up for her on the board of di­rec­tors at Io­vance. Dixon, the for­mer mar­ket­ing ex­ec at Bris­tol My­ers and Mer­ck, has seats on the boards of Arv­inas and Black Di­a­mond.

Vi­siox Phar­ma is bring­ing aboard Vi­cente Anido as a strate­gic ad­vi­sor. Anido was oust­ed as CEO at Aerie Phar­ma­ceu­ti­cals in Sep­tem­ber 2021 and was al­so chief ex­ec­u­tive at ISTA Phar­ma­ceu­ti­cals.

June Bray

June Bray is tak­ing a seat on the board of di­rec­tors of Cor­texyme, join­ing at a tur­bu­lent time for the San Fran­cis­co-based biotech. Most re­cent­ly, Bray was SVP, glob­al reg­u­la­to­ry af­fairs and med­ical writ­ing at Al­ler­gan, and pri­or to that, Bray was with Organon and Berlex Lab­o­ra­to­ries. To say the com­pa­ny has had it rough would be an un­der­state­ment: A failed at­tempt to bring for­ward an un­ortho­dox ap­proach to treat­ing Alzheimer’s has led to a com­plete re­make at the trou­bled biotech (tran­si­tion­ing its name to Quince Ther­a­peu­tics) last month, with Novos­teo CEO Dirk Thye and CMO Karen Smith com­ing aboard to help right the ship.

→ US-Dutch gam­ma delta T cell biotech La­va Ther­a­peu­tics is bub­bling up to the Peer Re­view sur­face by elect­ing James No­ble and Jay Back­strom to the board of di­rec­tors. No­ble co-found­ed Adap­ti­m­mune in 2008 and was CEO un­til 2019, and Back­strom — the ex-CMO and head of reg­u­la­to­ry af­fairs at Cel­gene —be­came a board mem­ber at Disc Med­i­cine not too long ago af­ter wrap­ping up his time lead­ing R&D at Ac­celeron.

Kathy Dong

Kathy Dong has been elect­ed to the board of di­rec­tors at Neu­ron23, Nan­cy Stagliano’s neu­ro start­up from the folks at West­lake Vil­lage BioPart­ners. A nine-year Gilead vet who held var­i­ous mar­ket­ing roles at the Cal­i­for­nia drug­mak­er, Dong has been the COO of Star Ther­a­peu­tics since 2019.

→ Swedish phar­ma com­pa­ny NorthX Bi­o­log­ics is adding some new faces to its board of di­rec­tors with the ap­point­ments of Lot­ta Ljungqvist, Richard Bergström, Math­ias Uh­lén and Lars Back­sell. Here’s a quick sum­ma­ry of each new mem­ber:

Ljungqvist for­mer­ly served as pres­i­dent and CEO of GE for the Nordic re­gion and is al­so the ex-CEO of Cy­ti­va’s Tes­ta Cen­ter for Bio­process In­no­va­tion; Bergström was ap­point­ed Swe­den’s vac­cine co­or­di­na­tor dur­ing the Covid-19 epi­dem­ic and was pre­vi­ous­ly di­rec­tor gen­er­al of the Eu­ro­pean Fed­er­a­tion of Phar­ma­ceu­ti­cal In­dus­tries and As­so­ci­a­tions; mean­while, Uh­lén is a pro­fes­sor in mi­cro­bi­ol­o­gy at the Roy­al In­sti­tute of Tech­nol­o­gy and Back­sell is a co-founder and for­mer CEO of Re­ci­pharm.

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.

Val­neva's chikun­gun­ya vac­cine on track for FDA nod af­ter long-term an­ti­body da­ta

The chikungunya virus met its match in Valneva’s vaccine candidate, VLA1553, according to data from an antibody persistence trial released today.

The trial found that 99% of 363 participants retained neutralizing antibodies 12 months after a single dose of vaccine in the company’s earlier, larger Phase III trial, called VLA1553-301. The participants from the long-term study will continue to be monitored for at least five years.

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

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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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Illustration: Assistant Editor Kathy Wong for Endpoints News

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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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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