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

2022-06-18 19:42:10 By : Ms. Alice Lee

→ 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.

→ 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.

→ 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.

→ 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.

→ Alex Zha­voronkov’s glob­al AI play­er In­sil­i­co Med­i­cine — which days ago added a ro­bot­ics lab to the com­pa­ny with a fresh in­jec­tion of $60 mil­lion — is 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.

→ 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 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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.

→ 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 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 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).

→ 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.

→ 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.

→ 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 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 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.

Merck is evaluating a potential buyout of embattled Seattle biotech Seagen, according to a report from the Wall Street Journal on Friday morning.

This is the newest development for the biotech after former CEO Clay Siegall stepped down from the company — while also forfeiting his board positions at other companies such as Umoja Biopharma — following allegations of domestic violence that surfaced last month. He was initially arrested in the early hours of April 23 after a physical altercation with his wife left her with multiple bruises, according to a police report. Siegall has denied the allegations.

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It’s one conference after the other in June. Now that #BIO22 is behind us, we’re shifting gears to Zach Brennan’s upcoming events at #DIA22 and on-the-ground coverage from Cannes Lions by Beth Snyder Bulik and Nicole DeFeudis. If you’re taking a long weekend like us — we’re off Monday in observance of Juneteenth — I hope it’s just what you need.

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A panel of the FDA’s outside experts voted 9-3 that Acadia Pharmaceuticals’ drug doesn’t appear to be effective at treating patients with Alzheimer’s-related psychosis.

The drug, Nuplazid, is already indicated for Parkinson’s-related psychosis, but Acadia has tried — and failed last year — to get another green light in Alzheimer’s psychosis. The drug never panned out in the clinic for patients with depression or schizophrenia, causing Acadia multiple R&D headaches over the years.

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The amyloid beta theory that has driven billions of dollars in failed Alzheimer’s research has taken yet another body blow.

Roche — and specifically its big sub Genentech — conceded defeat overnight for its closely watched Phase II API-ADAD trial of crenezumab in Alzheimer’s prevention. This follows twin Phase III failures — CREAD 1 and CREAD 2 in 2019 — and may well effectively mark the end of the line for a drug in-licensed from Switzerland’s AC Immune 16 years ago.

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The member countries of the World Trade Organization negotiated late into last night, finally offering up a compromised and watered-down way for some low-income countries to waive the intellectual property around certain Covid-19 vaccine ingredients and manufacturing processes, potentially paving the way for compulsory licensing for these vaccines.

While only in effect initially for five years, the waiver would hypothetically allow low-income countries to bypass certain Pfizer and Moderna patents to produce more Covid-19 vaccines.

Another OK, another 2,000 potential patients.

On Thursday, Rhythm Pharmaceuticals received its second FDA green light for its obesity management drug for those with ultra-rare genetic diseases, this time for Bardet-Biedl syndrome, a disease that impacts a number of organs but with early-onset obesity as a major symptom. And the company also engineered a royalty deal netting it up to $100 million.

The FDA approved the drug, known as setmelanotide and marketed as Imcivree, for patients 6 years and up after Phase III data in 31 Bardet-Biedl patients showed it decreased BMI by around 8% compared to placebo. Rhythm chairman and CEO David Meeker noted that while BMI was not a perfect measurement, the company opted to use it over weight because its study included pediatric patients who were still growing.

One month after telling the SEC it would lay off about a fourth of its staff, Scholar Rock is following the blueprint laid out by other public biotechs during the bear market: raising some big cash on the heels of a data readout.

The Cambridge, MA-based company announced Friday morning it plans to raise $205 million in a public offering after touting two-year Phase II data in spinal muscular atrophy as positive, also on Friday. The figure represents more money than Scholar Rock’s market cap at Thursday’s closing, which clocked in at $171.6 million.

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More than 18 months after adults were able to start receiving Pfizer-BioNTech’s and Moderna’s Covid-19 vaccines, kids as young as six months are on the verge of being able to get inoculated against the pandemic virus.

The FDA authorized the Pfizer-BioNTech and Moderna vaccines Friday morning under EUA after the agency’s outside advisors unanimously favored (21-0) administering the shots. Parents and caregivers just have to wait for the CDC to sign off before the youngest of America’s kids can get the vaccine.

A couple of weeks after being told by the powers that be at Nasdaq that it will need to get its battered share price out of penny stock territory if it wants to keep its listing, Mereo BioPharma has picked up some steam today with the rumor that AstraZeneca has come calling to see about an acquisition.

If it’s accurate, AstraZeneca — which has developed into a powerhouse oncology player with a very select appetite for high-dollar deals — is shopping the bargain basement on Wall Street after the biotech bear market eviscerated Mereo’s market cap.

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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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