Nel­son Am­bro­gio

→ Bay­er has hand­ed out two pro­mo­tions in its US op­er­a­tions, with Nel­son Am­bro­gio and John Berrios both get­ting the bump. Am­bro­gio be­comes SVP, gen­er­al man­ag­er of on­col­o­gy, while Berrios take Am­bro­gio’s place as SVP, gen­er­al man­ag­er of women’s health­care. Am­bro­gio is a long­time Bay­er vet who’s held such ti­tles in­ter­na­tion­al­ly as gen­er­al man­ag­er in Aus­tralia and New Zealand and man­ag­ing di­rec­tor in Por­tu­gal. Berrios, who joined Bay­er in 2016 af­ter 15 years at As­traZeneca, takes on his new re­spon­si­bil­i­ties af­ter a year as VP, com­mer­cial op­er­a­tions.

A 30-year makeover is now in the works for Bay­er’s Berke­ley cam­pus that would add 918,000 square feet of build­ing space.

→ Late last month, Hu­mani­gen inched an­oth­er step clos­er to its hopes of fil­ing an emer­gency use au­tho­riza­tion, trot­ting out pos­i­tive Phase III lenzilum­ab da­ta for Covid-19 pa­tients. This week Cameron Dur­rant’s crew has poached Adri­an Kil­coyne from As­traZeneca to be CMO. Kil­coyne was the wob­bling phar­ma gi­ant’s VP of on­col­o­gy glob­al med­ical af­fairs, head of ev­i­dence gen­er­a­tion and ex­ter­nal al­liances, and he led the launch of Calquence, which along with Farx­i­ga saw no sig­nif­i­cant ben­e­fit when re­pur­posed for Covid-19. Pri­or to As­traZeneca, Kil­coyne was Cel­gene’s ex­ec­u­tive med­ical di­rec­tor, glob­al lym­phoma pro­gram lead, clin­i­cal R&D.

Robert Langer

→ A shin­ing bea­con has ar­rived at Je­re­my Levin‘s Ovid in the form of Robert Langer. Langer comes on af­ter the com­pa­ny’s lead drug was a bust in a late-stage test. Langer, a fa­bled MIT in­ves­ti­ga­tor and se­r­i­al en­tre­pre­neur, has signed on as chair to the sci­en­tif­ic board — of­fer­ing guid­ance a day af­ter Levin of­fi­cial­ly tossed both pro­grams for OV101. In his ca­reer, Langer has helped start more than 30 biotechs, of­ten steered by one of his post­docs. In ad­di­tion, he was an ear­ly backer of Mod­er­na, serv­ing as an aca­d­e­m­ic co-founder of the com­pa­ny. Langer had an ear­ly stake in Mod­er­na, which led him to bil­lion­aire sta­tus.

Ja­mi Ru­bin

→ While she was with Gold­man Sachs, Ja­mi Ru­bin liked to put biotech ex­ecs un­der the mi­cro­scope with tough lines of ques­tion­ing. Ru­bin’s lat­est chal­lenge takes her to EQRx, where as CFO she’ll be in the dri­ver’s seat to fur­ther the com­pa­ny’s vi­sion of rewrit­ing the rule book for drug pric­ing. Af­ter a decade at Gold­man Sachs, Ru­bin then be­came a part­ner at PJT Part­ners, lend­ing her ex­per­tise to biotechs and phar­ma­ceu­ti­cal com­pa­nies. Ru­bin isn’t the on­ly new face at EQRx, with Kent Rogers get­ting the nod as chief cus­tomer of­fi­cer fol­low­ing his time at Unit­ed­Health Group’s Op­tum­Rx as SVP of in­dus­try re­la­tions.

→ Genen­tech’s very own Sushil Pa­tel is hit­ting the ex­it af­ter a 20-year stint and hop­ping aboard tiny on­colyt­ic virus biotech Replimune as their CCO. Known as the for­mer Tecen­triq ‘CEO’ at Genen­tech, Pa­tel served as glob­al on­col­o­gy fran­chise head for lung and skin can­cer and rare/ag­nos­tic tu­mor types.

Mar­tin Mur­phy

→ Chris­t­ian Itin has stepped down as chair­man of the board at Au­to­lus and has been re­placed by Syn­cona CEO Mar­tin Mur­phy. Itin will re­main CEO at Au­to­lus, the Lon­don-based T cell ther­a­py biotech that jet­ti­soned 20% of its staffers at the start of the year. Itin had chaired Au­to­lus, and Mur­phy had been a non-ex­ec­u­tive di­rec­tor, since the start of the com­pa­ny in 2014.

→ Just af­ter ex-Mof­fitt Can­cer Cen­ter CEO Alan List took his place at Pre­ci­sion Bio­Sciences, Christo­pher Heery has land­ed at Ar­cel­lx as CMO. Heery held the post at Pre­ci­sion for near­ly two years and was al­so CMO at Bavar­i­an Nordic. Be­fore step­ping in­to biotech, he was the Na­tion­al Can­cer In­sti­tute’s head of the clin­i­cal tri­als group of the Lab­o­ra­to­ry of Tu­mor Im­munol­o­gy and Bi­ol­o­gy. Else­where at Ar­cel­lx, which raised $115 mil­lion in a Se­ries C last week to de­vel­op CAR-T ther­a­pies, Neer­aj Teo­tia wrapped up his time as Nevro’s VP of fi­nance and has been cho­sen as chief com­mer­cial of­fi­cer. Pri­or to Nevro, Teo­tia worked in R&D and new busi­ness de­vel­op­ment at J&J.

Luisa Salter-Cid

→ Luisa Salter-Cid is re­sign­ing as CSO of San Diego-based Gos­samer Bio, and Lau­ra Carter has been pro­mot­ed from with­in to re­place her, start­ing April 30. Carter, the SVP, re­search & trans­la­tion­al bi­ol­o­gy at Gos­samer since 2019, was pre­vi­ous­ly the SVP, bi­ol­o­gy at Lyc­era. Salter-Cid de­vot­ed 13 years to Bris­tol My­ers Squibb be­fore mak­ing the leap in 2018 to Gos­samer, led once again by Fa­heem Has­nain af­ter its lead drug flopped — prompt­ing his old Re­cep­tos col­league Sheila Gu­jrathi to step down in No­vem­ber.

→ Last month, Rand Suther­land was named pres­i­dent of Lex­ing­ton, MA-based mR­NA play­er Trans­late Bio, and more lead­er­ship moves have been made once again with Bren­dan Smith on board as CFO along with two oth­er ap­point­ments. Be­fore his most re­cent gig as a part­ner at Boston Con­sult­ing Group, Smith was Pfiz­er’s VP, head of busi­ness op­er­a­tions for world­wide R&D. Trans­late Bio al­so liked what they saw in Greg Troiano enough to pro­mote him to chief man­u­fac­tur­ing of­fi­cer. An­oth­er Pfiz­er vet (VP, nanomed­i­cine de­vel­op­ment and en­gi­neer­ing), Troiano came on the scene as Trans­late Bio’s SVP of tech­ni­cal op­er­a­tions al­most a year ago. Fi­nal­ly, 12-year Ver­tex alum Jim Sul­li­van be­came SVP, pul­monary dis­cov­ery in Jan­u­ary af­ter be­ing ex­ec­u­tive di­rec­tor, head of trans­la­tion­al bi­ol­o­gy at Sana.

Abra­ham Ceesay

→ With No­vaQue­st and pre­vi­ous backer Bain plunk­ing down $125 mil­lion in non-di­lu­tive fund­ing to pro­pel its Phase III tava­padon pro­gram for Parkin­son’s, Tony Coles-led Cerev­el has ap­point­ed Abra­ham Ceesay pres­i­dent of the com­pa­ny. The Gen­zyme vet makes the tran­si­tion to Cerev­el af­ter lead­ing Tibu­rio Ther­a­peu­tics as the Cy­dan spin­out’s first CEO. Ceesay was al­so COO of scPhar­ma­ceu­ti­cals and VP of mar­ket­ing at Iron­wood.

→ Glob­al qual­i­ty, com­pli­ance and reg­u­la­to­ry con­sult­ing group Val­i­dant has ac­quired Green­leaf Health. As part of the ac­qui­si­tion, Val­i­dant has placed Patrick Ro­nan, the founder and for­mer CEO of Green­leaf, at the helm of Val­i­dant as CEO. Be­fore his stint at Green­leaf, Ro­nan was VP of reg­u­la­to­ry pol­i­cy & ex­ter­nal af­fairs at No­var­tis. In ad­di­tion, he has served as chief of staff and as­sis­tant com­mis­sion­er of leg­is­la­tion on Capi­tol Hill.

Matthew Gantz

→ Jeff Aronin’s cell and gene ther­a­py crew at Penn­syl­va­nia-based Cas­tle Creek Bio­sciences has tapped Matthew Gantz as pres­i­dent and CEO, while his pre­de­ces­sor, John Maslows­ki, won’t stray too far at all as he slides in­to the COO post. Gantz had helmed Stock­holm-based Pri­ma­ry hy­per­ox­aluria biotech Ox­Thera since 2017, when he suc­ceed­ed Elis­a­beth Lind­ner in the top spot. Since 2012, Gantz has served on the board of di­rec­tors at an­oth­er Stock­holm com­pa­ny, So­bi, which forked over $250 mil­lion up­front for com­mer­cial­iza­tion of Apel­lis’ rare dis­ease drug pegc­eta­coplan out­side the US.

→ While we’re on the sub­ject of Penn­syl­va­nia biotechs, Cor­leen Roche has signed on to Im­munome, which net­ted a De­part­ment of De­fense con­tract to de­vel­op biosyn­thet­ic con­va­les­cent plas­ma, as CFO. Al­though she shares a name with a phar­ma gi­ant, Roche in­stead was the US CFO at Bio­gen the last two years and held fi­nan­cial lead­er­ship ti­tles at Sanofi, Wyeth (now Pfiz­er) and San­doz. Her ar­rival fol­lows that of chief de­vel­op­ment of­fi­cer Den­nis Giesing at Im­munome, which is us­ing its hu­man mem­o­ry B cell plat­form for ther­a­pies in the on­col­o­gy and in­fec­tious dis­ease are­nas in ad­di­tion to Covid-19.

David Chung

→ An­oth­er domi­no has fall­en at In­ter­cept now that David Chung has joined Or­biMed-backed Bio­haven spin­out BioShin out of Shang­hai, which scored a $60 mil­lion round back in Sep­tem­ber. The stam­pede out the door at In­ter­cept shows few signs of abat­ing, with Chung leav­ing to be BioShin’s chief strat­e­gy of­fi­cer and head of busi­ness de­vel­op­ment af­ter three years as VP, head of busi­ness de­vel­op­ment at the NASH biotech that can’t seem to get off the strug­gle bus. The Bris­tol My­ers vet was se­nior di­rec­tor, strat­e­gy & cor­po­rate de­vel­op­ment at Jazz Phar­ma­ceu­ti­cals be­fore mov­ing to In­ter­cept.

→ We now head for the moun­tains of Boul­der, CO, where NASH and Wil­son’s dis­ease biotech Enve­da Bio­sciences has plucked Sotirios Karathana­sis from Neo­Prog­en to be CSO. Karathana­sis, the ex-CSO of en­docrine and car­dio­vas­cu­lar re­search at Lil­ly Re­search Lab­o­ra­to­ries, brings fur­ther Big Phar­ma ex­pe­ri­ence from As­traZeneca (with such po­si­tions as VP and head of bio­sciences) and Pfiz­er (as di­rec­tor of car­dio­vas­cu­lar phar­ma­col­o­gy at Pfiz­er Glob­al Re­search & De­vel­op­ment). Karathana­sis was VP of R&D at Neo­Prog­en, which is de­vel­op­ing ex­o­some-based ther­a­pies and has of­fices across the street from Ori­ole Park at Cam­den Yards in Bal­ti­more.

Isaac Klein

→ Ameet Nath­wani’s bio­mol­e­c­u­lar con­den­sate shop Dew­point Ther­a­peu­tics, which has sealed deals with Mer­ck, Bay­er and Pfiz­er, has re­cruit­ed Isaac Klein as CSO. Klein was at MIT’s White­head In­sti­tute as a re­searcher in Rick Young’s lab — plac­ing his em­pha­sis on “un­der­stand­ing the role of con­den­sates in can­cer, tran­scrip­tion, and drug ac­tiv­i­ty” — and he’s a med­ical on­col­o­gist at the Dana-Far­ber Can­cer In­sti­tute.

→ New York can­cer and rare dis­ease biotech Pro­tara Ther­a­peu­tics has tapped Martín Se­bas­t­ian Oli­vo as CMO. Oli­vo comes to Pro­tara from Gilead, where he was VP, breast can­cer clin­i­cal de­vel­op­ment lead, slid­ing over from Im­munomedics af­ter the $21 bil­lion buy­out. Oli­vo was in the on­col­o­gy busi­ness group at Ei­sai for six years and then spent the next year at the Dai­ichi Sankyo Can­cer En­ter­prise as glob­al clin­i­cal lead.

David Nichols

→ David Nichols has signed on to be chief tech­ni­cal of­fi­cer at stem cell trans­plan­ta­tion play­er and Beam’s ADC part­ner, Ma­gen­ta Ther­a­peu­tics. Nichols makes the tran­si­tion to Ma­gen­ta af­ter five years at Kiniksa, the last two as SVP of tech­ni­cal op­er­a­tions, and he’s been head of CMC bi­o­log­ics at Tesaro. Ma­gen­ta is al­so putting its stem cell plat­form and ADC de­vel­op­ment pow­ers to the test as a means to block HIV, part of a $14.6 mil­lion grant from the NIH with part­ners such as USC and Fred Hutch.

Celia Lin

→ For­mer­ly Tru­code Gene Re­pair, the re­vamped Ve­ra Ther­a­peu­tics — de­vel­op­er of the IgA nephropa­thy drug at­aci­cept that raked in an $80 mil­lion Se­ries C round in Jan­u­ary — has made three new ap­point­ments: Celia Lin (CMO), Tad Thomas (head of prod­uct de­vel­op­ment and man­u­fac­tur­ing) and Joseph Young (SVP of fi­nance). Lin was a med­ical di­rec­tor in clin­i­cal de­vel­op­ment and med­ical af­fairs at Am­gen, and then for the last six years she’s served as a se­nior med­ical di­rec­tor at Genen­tech. Thomas, who has filled process de­vel­op­ment and CMC po­si­tions at Alex­ion, Ipsen and Bay­er, among oth­ers, was re­cent­ly as­so­ciate VP, tech­ni­cal op­er­a­tions at Codex­is. And Young leaves Plexxikon af­ter 14 years, start­ing out as con­troller and climb­ing the lad­der to SVP, fi­nance.

→ Alan Smith has got­ten the call to be chief tech­nol­o­gy of­fi­cer of South San Fran­cis­co-based Am­bys Med­i­cines, the cell and gene ther­a­py start­up backed by Third Rock and Take­da. Smith leaves Man­ny Si­mons’ squad at Ak­ou­os af­ter less than a year as CTO, and be­fore that he was Bel­licum’s EVP of tech­ni­cal op­er­a­tions.

Patrick Big­ot

→ The lead­er­ship team is fur­ther tak­ing shape — sor­ry, Peer Re­view couldn’t re­sist — at Seat­tle gene ther­a­py out­fit Shape Ther­a­peu­tics, which has brought on Patrick Big­ot as CBO af­ter Gary Fortin took over as COO a few months ago. Big­ot just had a short stay as Ver­i­ly’s glob­al head, strate­gic al­liances, but pri­or to that he was with Genen­tech from 2006-19, a run that cul­mi­nat­ed in his du­ties as VP of al­liance man­age­ment.

→ Co-CEOs Justin Klee and Josh Co­hen have a new staffer at ALS-fo­cused Amy­lyx, and it’s Chris Aiel­lo, who’s been se­lect­ed as head of Cana­da and gen­er­al man­ag­er. At Sanofi Gen­zyme Cana­da, Aiel­lo was a dual busi­ness unit di­rec­tor of the rare dis­ease and the rare blood dis­or­ders units. He had been gen­er­al man­ag­er of Cana­da for Biover­a­tiv, which Sanofi swept up for $11.6 bil­lion in 2018.

Stu­art Chaf­fee

→ Kymera Ther­a­peu­tics co-founder Stu­art Chaf­fee is mov­ing on to be CBO of Affini­vax, awash in fund­ing af­ter Jan­u­ary’s $226 mil­lion round and striv­ing to un­seat Pfiz­er as the undis­put­ed Pre­vnar 13 cham­pi­on. Chaf­fee, a Bio­gen alum who was al­so Kymera’s head of busi­ness op­er­a­tions, just logged three years as CBO and CFO of Mar­cio Souza-led Prax­is Pre­ci­sion Med­i­cines.

→ Al­lakos — which added for­mer Au­dentes Ther­a­peu­tics CEO and pres­i­dent Na­tal­ie Holles to its board of di­rec­tors last De­cem­ber — has tapped Baird Rad­ford as CFO. Rad­ford comes from Aim­mune Ther­a­peu­tics, where he served as SVP of fi­nance.

Charles Mor­ris

→ Bel­gian CAR-T biotech Celyad On­col­o­gy has pegged Charles Mor­ris as CMO in the first C-suite change since David Gilham was bumped up to CSO last spring. Mor­ris cut his teeth at As­traZeneca with his in­volve­ment in de­vel­op­ing Faslodex and in the ear­ly clin­i­cal de­vel­op­ment of Ires­sa. Mor­ris comes to Celyad af­ter his stint as CMO at Ra­dius Health, now led by Kel­ly Mar­tin.

→ Steven Cha has been named CMO of nat­ur­al killer cell ther­a­py-fo­cused NKGen Biotech, fol­low­ing close be­hind CFO Philip Moody’s ap­point­ment two weeks ago. The ex-glob­al clin­i­cal lead in ear­ly on­col­o­gy de­vel­op­ment at Pfiz­er makes the switch to NKGen Biotech from Sa­mumed, which just re­brand­ed to Bios­plice Ther­a­peu­tics last week, where he was VP of on­col­o­gy.

→  Hi­malaya Ther­a­peu­tics has made the ad­di­tion of Nicholas Des­jardins as CFO and cor­po­rate de­vel­op­ment of­fi­cer. Des­jardins has ex­pe­ri­ence from Cowen and Stifel, AS­GARD Part­ners, Bei­jing REL­TEC and Price­Wa­ter­house, Bei­jing.

Lisa Per­ci­val

→ Helmed by Jeff Hat­field for the last six months, Vi­vid­ion out of San Diego has wel­comed Xi­ao­hu Deng as head of tech­ni­cal op­er­a­tions and Lisa Per­ci­val as head of reg­u­la­to­ry. Deng moves on to Vi­vid­ion af­ter a cou­ple years at Virac­ta Ther­a­peu­tics as SVP, prod­uct de­vel­op­ment, and from 2014-19 he was Ku­ra On­col­o­gy’s se­nior di­rec­tor, head of CMC. Per­ci­val, a 19-year reg­u­la­to­ry vet at Bris­tol My­ers, be­came an en­tre­pre­neur in res­i­dence, reg­u­la­to­ry strat­e­gy at At­las Ven­ture af­ter a short stint at Zaf­gen.

→ Cam­bridge, MA-based Nim­bus Ther­a­peu­tics has three new ex­ecs, nam­ing Avinash Phad­ke VP of CMC; Bhaskar Sri­vas­ta­va VP of ear­ly clin­i­cal de­vel­op­ment; and Ajay Upad­hyay VP of clin­i­cal op­er­a­tions. Phad­ke spent 18 years in nu­mer­ous ca­pac­i­ties at Achillion — bought out by Alex­ion for $930 mil­lion — work­ing his way up to VP, head of CMC. Sri­vas­ta­va piv­ots to Nim­bus af­ter a five-year tenure at Janssen that saw him be­come se­nior di­rec­tor, ear­ly de­vel­op­ment trans­la­tion­al sci­ence and med­i­cine in im­munol­o­gy. Fi­nal­ly, Upad­hyay is the ex-chief of staff of Glax­o­SmithK­line’s US on­col­o­gy busi­ness unit who lat­er moved on to Astel­las, leav­ing in 2018 as ex­ec­u­tive di­rec­tor of clin­i­cal and out­comes sci­ences.

Mar­cos Mil­la

→ With de­vel­op­ment of an an­ti­body un­der­way for Covid-19 af­ter a mod­est $16 mil­lion Se­ries B, Seat­tle’s Lu­men Bio­science has re­vealed a string of hires with Carl Ma­son as se­nior med­ical di­rec­tor, Cristin Wag­n­er as VP, head of le­gal, and Steven Lan­das as VP and con­troller. Ma­son had held the same ti­tle at Parex­el; Wag­n­er brings le­gal ex­per­tise in the Pa­cif­ic North­west from her time at Schwabe, Williamson & Wy­att; and Lan­das is the for­mer di­rec­tor of ac­count­ing at Seat­tle Ge­net­ics, now Seagen. Ad­di­tion­al­ly, ex-Syn­thorx CSO Mar­cos Mil­la has joined Lu­men’s board of di­rec­tors.

→ Nex­im­mune, which is work­ing its way to an IPO and has the sup­port of the LLS on its nanopar­ti­cles work, has en­list­ed Chad Ru­bin as SVP, cor­po­rate af­fairs. Pri­or to Nex­im­mune, Ru­bin was with Sole­bury Trout.

→ Im­munomod­u­la­tion-fo­cused biotech Cy­to­com, which merged with Cleve­land Bi­o­Labs to grab a spot on Nas­daq, has pulled in Stephen Wil­son as head of glob­al in­no­va­tion. Wil­son hails from the La Jol­la In­sti­tute of Im­munol­o­gy, where he spent near­ly 25 years in bio­med­ical re­search and served as the re­search fa­cil­i­ty’s EVP and COO.

Tyrell Rivers

→ Gilead part­ner Goldfinch Bio has made a board of di­rec­tors triple play with Meryl Zaus­ner, Mo Cow­an and Tyrell Rivers. Zaus­ner, a long­time No­var­tis ex­ec, is al­so on the board at Seres; Cow­an was in­ter­im Sen­a­tor of Mass­a­chu­setts be­fore Ed Markey took the seat and is GE’s pres­i­dent, glob­al gov­ern­ment af­fairs and pol­i­cy and de­vel­oped mar­kets; and since 2014 Rivers has been ex­ec­u­tive di­rec­tor of cor­po­rate de­vel­op­ment at As­traZeneca.

→ David Whead­on has made his way to the board of di­rec­tors at Vaxart, which is aim­ing to ad­vance its oral Covid-19 tablet vac­cine to Phase II tri­als, af­ter join­ing the board at Karuna Ther­a­peu­tics a few months back. Whead­on, the for­mer SVP, glob­al reg­u­la­to­ry af­fairs, pa­tient safe­ty and qual­i­ty as­sur­ance at As­traZeneca, was al­so a reg­u­la­to­ry ex­ec at Ab­bott and GSK.

Kim Sablich

→ Just a short dri­ve from the Stan­ford cam­pus, Eiger Bio­Phar­ma­ceu­ti­cals — the re­cip­i­ent of the first FDA ap­proval for pre­ma­ture ag­ing dis­or­der Prog­e­ria — has giv­en Kim Sablich a seat on the board of di­rec­tors. Sablich was in Peer Re­view al­most a year ago when she took the job of EVP, gen­er­al man­ag­er, North Amer­i­ca at Jazz Phar­ma­ceu­ti­cals.

→ Leila Al­land and Don­ald Wuchterl are the lat­est mem­bers of Abeona’s board of di­rec­tors. Al­land, who has con­sid­er­able Big Phar­ma ex­pe­ri­ence in on­col­o­gy de­vel­op­ment at No­var­tis, Bris­tol My­ers and As­traZeneca, is CMO of PMV Phar­ma­ceu­ti­cals. Af­ter five years at Au­dentes, Wuchterl just joined T-knife as chief man­u­fac­tur­ing of­fi­cer ear­li­er this month.

Bob Oliv­er

→ Psy­Bio Ther­a­peu­tics — which ear­li­er this month ap­point­ed Mike Spi­garel­li as CMO — has made a new ad­di­tion to its team with the ap­point­ment of Bob Oliv­er to its board of di­rec­tors. This isn’t Oliv­er’s first board ap­point­ment, he for­mer­ly sat on the board of Im­munomedics. Oliv­er brings with him his ex­pe­ri­ence from his time as pres­i­dent and CEO of Ot­su­ka Amer­i­ca Phar­ma­ceu­ti­cal. Pri­or to that, he was with Wyeth and V Clin­Bio.

→ Third Rock-backed Cedil­la, which reeled in $57.6 mil­lion for small mol­e­cule pro­grams to fight can­cer last Oc­to­ber, has re­cruit­ed Chris Bow­den to its board of di­rec­tors. For­mer­ly, Bow­den was CMO of Agios. Pri­or to that, he was with Genen­tech and Janssen.

Yi Lar­son

→ Ver­sant and ven­Bio-backed Rayze­Bio has reeled in Yi Lar­son to its board of di­rec­tors. Lar­son for­mer­ly served as man­ag­ing di­rec­tor of health­care in­vest­ment bank­ing at Gold­man Sachs. In ad­di­tion, Lar­son was CFO of Turn­ing Point Ther­a­peu­tics and cur­rent­ly serves as CFO of Lian­Bio.

→ Drug dis­cov­ery com­pa­ny C4X Dis­cov­ery Hold­ings has named Si­mon Har­ford as non-ex­ec­u­tive di­rec­tor. Har­ford is the cur­rent CFO at Al­bireo Phar­ma and was the for­mer CFO of Parex­el In­ter­na­tion­al. Pri­or to that, he was with GSK and Eli Lil­ly.

In ad­di­tion to Lar­son’s ap­point­ment, Rayze­Bio has brought on Derek Cole as head of dis­cov­ery; Kathie Huynh as VP of fi­nance; and Daniel Kim as se­nior di­rec­tor of ra­dio­phar­ma­ceu­ti­cals.

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.

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.

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).