Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado to fo­cus on CSO job at Rain Ther­a­peu­tics

Jef­frey Sil­ber

→ A Big Phar­ma vet has joined Cam­bridge, MA up­start Vedan­ta Bio­sciences to help de­vel­op and ex­pand on its mi­cro­bio­me-de­rived bac­te­ria port­fo­lio.

Jef­frey Sil­ber signed on as CMO of Vedan­ta af­ter 4 years at EMD Serono as their SVP, glob­al clin­i­cal de­vel­op­ment. Sil­ber worked his way through the ranks at Mer­ck in the late 1990s, even­tu­al­ly be­com­ing their VP and ther­a­peu­tic area head, vac­cine clin­i­cal re­search. And af­ter 16 years at the phar­ma gi­ant, Sil­ber moved on to Ab­b­Vie to be their VP, strate­gic port­fo­lio de­vel­op­ment.

Else­where at Vedan­ta, Bio­gen and Se­qirus alum Nan­cy Chiu Wilk­er takes on the role of VP, le­gal.

Robert Doe­bele

→ Rolling along with $63 mil­lion in new fund­ing that was an­nounced a cou­ple weeks ago, Rain Ther­a­peu­tics of­fi­cial­ly named Robert Doe­bele CSO at Rain Ther­a­peu­tics — af­ter serv­ing as act­ing CSO since he co-found­ed the biotech in 2017. He tran­si­tions to EVP and CSO full-time, leav­ing his pro­fes­sor­ship at the Uni­ver­si­ty of Col­orado School of Med­i­cine. Doe­bele had been at CU since 2008 and al­so led the Tho­racic On­col­o­gy Re­search Ini­tia­tive at the Uni­ver­si­ty of Col­orado Can­cer Cen­ter.

→ Ex-Or­chard Ther­a­peu­tics CEO Mark Rothera is back lead­ing an­oth­er biotech, tak­ing over as pres­i­dent and CEO of Lon­don-based Si­lence Ther­a­peu­tics, which an­nounced its in­tent to list on Nas­daq back in May. Rothera left Or­chard in March af­ter hold­ing the top spot for more than 2½ years. Pri­or to Or­chard, he was chief com­mer­cial of­fi­cer at PTC Ther­a­peu­tics from 2013-17 and, for less than a year, was glob­al pres­i­dent of Aege­ri­on Phar­ma­ceu­ti­cals from 2012-13.

Dan Stan­er

→ Run­ning full throt­tle on a Phase III tri­al of its mR­NA-1273 Covid-19 vac­cine can­di­date, Mod­er­na has made Eli Lil­ly alum Dan Stan­er VP and gen­er­al man­ag­er in Switzer­land, the first sub­sidiary for the biotech out­side of North Amer­i­ca. Dur­ing al­most 19 years at Lil­ly, Stan­er held a range of mar­ket­ing and strate­gic posts, and left in 2019 as the phar­ma gi­ant’s area gen­er­al man­ag­er, Mid­dle East & Pak­istan re­gion. A Swiss na­tion­al, Stan­er was Lil­ly’s man­ag­ing di­rec­tor in Switzer­land from 2005-11.

Lewis Cant­ley’s metas­ta­tis-fo­cused start­up Volas­tra Ther­a­peu­tics has cho­sen ex-Sanofi and Pfiz­er on­col­o­gy ex­ec Charles Hugh-Jones as their CEO. Be­fore grab­bing the top spot here, Hugh-Jones had been CMO at Al­ler­gan, thus con­tin­u­ing the ex­o­dus af­ter the merg­er with Ab­b­Vie as Brent Saun­ders sets his sights on a $460 mil­lion SPAC. Hugh-Jones has al­so been an on­col­o­gy di­rec­tor at Scher­ing/Bay­er in the mid 2000s.

Lorence Kim

Third Rock has reeled in ex-Mod­er­na CFO Lorence Kim as a new ven­ture part­ner. Join­ing the team along­side Kim as ven­ture part­ners are David Kauf­man, who pre­vi­ous­ly served as CMO and head of trans­la­tion­al de­vel­op­ment at the Bill and Melin­da Gates Med­ical Re­search In­sti­tute; and An­drea van El­sas — who most re­cent­ly served as CSO at Aduro Biotech, which was re­cent­ly tak­en over in a re­verse merg­er af­ter years of set­backs in the clin­ic.

Lee Rauch

→ Mi­cro­cap mi­croR­NA play­er mi­Ra­gen‘s CEO William Mar­shall has re­signed, leav­ing COO Lee Rauch in charge as the new chief to over­see a “re­view of strate­gic al­ter­na­tives” — of­ten a sign that the board is ea­ger for a sale, al­though in-li­cens­ing and oth­er deals are al­so on the ta­ble. Mar­shall leaves in the midst of 44 job cuts and an R&D re­struc­tur­ing. Rauch, a biotech vet who joined just three months ago, and has a slew of ex­pe­ri­ence un­der her belt from po­si­tions at Glob­al Blood Ther­a­peu­tics, Onyx Phar­ma­ceu­ti­cals, Fortress Biotech and Nuon Ther­a­peu­tics among oth­ers.

→ At the same time as their of­fi­cial launch fol­low­ing a seed fundrais­ing round led by SV Health In­vestors and joined by Can­cer Re­search UK, Cellinta has tapped So­raya Bekkali as CEO. Bekkali hopped aboard the com­pa­ny af­ter a stint as CEO and di­rec­tor of the board of Syn­cona-backed Gy­ro­scope Ther­a­peu­tics. Pri­or to that, she was SVP CMO at Lyso­gene.

Leonard Blum

→ Mer­ck vet and ICOS com­mer­cial leader Leonard Blum has been named pres­i­dent and CEO of neu­ro­bi­ol­o­gy play­er XW­Phar­ma, which just com­plet­ed a $40 mil­lion Se­ries C. Blum held sev­er­al lead­er­ship roles at Mer­ck from 1987-2000, and from there, he helped bring Cialis to the mar­ket at ICOS while he was al­so their SVP, sales and mar­ket­ing, stick­ing around un­til its 2007 ac­qui­si­tion by Lil­ly. Blum, a for­mer US Army Spe­cial Forces of­fi­cer, was most re­cent­ly a con­sult­ing com­mer­cial ex­ec­u­tive at Madri­gal Phar­ma­ceu­ti­cals.

Rock­well Med­ical just found their pres­i­dent and CEO Rus­sell El­li­son in April, and now the iron de­fi­cien­cy-fo­cused metro De­troit phar­ma has an­oth­er Rus­sell to go with him as CFO and CBO: Rus­sell Skib­st­ed. He has been CFO at a num­ber of oth­er com­pa­nies, in­clud­ing his most re­cent posts at Bi­o­Time and its sub­sidiaries AgeX Ther­a­peu­tics, On­co­cyte and As­te­r­ias Bio­ther­a­peu­tics.

Fitzroy Dawkins

→ One of the many up­sized IPOs in the 2020 boom, hema­tol­ogy and on­col­o­gy play­er For­ma Ther­a­peu­tics has bol­stered its ex­ec­u­tive team with Fitzroy Dawkins as VP, clin­i­cal de­vel­op­ment and Ruth du Moulin as VP, med­ical af­fairs. Dawkins comes from In­cyte, where he was their ex­ec­u­tive di­rec­tor, on­col­o­gy drug de­vel­op­ment, while du Moulin hails from Take­da’s on­col­o­gy glob­al busi­ness unit in the role of VP, med­ical af­fairs and head of glob­al on­col­o­gy med­ical com­mu­ni­ca­tions.

→ Cam­bridge, MA syn­thet­ic bi­ol­o­gy play­er Syn­log­ic, which broke off a pact with Ab­b­Vie in May to de­vel­op an IBD treat­ment but is a fre­quent col­lab­o­ra­tor with Gink­go Bioworks, has re­cruit­ed David Ha­va as their CSO af­ter a brief run in the same role at Me­tera Phar­ma­ceu­ti­cals. Ha­va rose to CSO and led the R&D team dur­ing his 12 years at Pul­ma­trix, where he start­ed out as a se­nior sci­en­tist.

Michael Diem

→ Launched by Ver­sant’s Car­lo Riz­zu­to and CEO La­lo Flo­res, and chaired by Joe Jimenez, Philadel­phia-based Cen­tu­ry Ther­a­peu­tics has wel­comed Michael Diem as CBO. Be­fore head­ing to Cen­tu­ry, which de­vel­ops iP­SC-de­rived al­lo­gene­ic cell ther­a­pies to fight can­cer, Diem spent 3 years at Am­i­cus Ther­a­peu­tics as SVP and head of cor­po­rate and busi­ness de­vel­op­ment. He’s al­so held BD posts at As­traZeneca and GSK.

→ Cam­bridge, MA cell and gene ther­a­py biotech Ob­sid­i­an Ther­a­peu­tics has cor­ralled Jan ter Meulen as CSO. A Mer­ck alum who was their head of ba­sic vac­cine re­search, ter Meulen moves over to Ob­sid­i­an af­ter a 6-year stay as CSO of Im­mune De­sign, which would even­tu­al­ly be sold to Mer­ck for $300 mil­lion in ear­ly 2019.

→ Long­time Ra­dius Health CFO Nick Har­vey is mov­ing on to Adicet Bio in the same po­si­tion. Har­vey comes to the biotech, which de­vel­ops al­lo­gene­ic gam­ma delta T cell ther­a­pies with Re­gen­eron as a part­ner, af­ter his most re­cent CFO stint at Cen­trex­ion Ther­a­peu­tics. He was at Ra­dius Health from 2006-17 and led the com­pa­ny through its ini­tial IPO.

Rona An­halt

Alex­is Borisy‘s start­up EQRx has brought on a slew of new ex­ec hires. The ap­point­ments in­clude Rona An­halt as chief peo­ple of­fi­cer; Chris­t­ian An­toni as chief de­vel­op­ment of­fi­cer; Er­ic Hedrick as chief physi­cian ex­ec­u­tive; and Daniel Hoey as chief of tech­ni­cal op­er­a­tions. In ad­di­tion, for­mer chief ex­ec­u­tive of NICE An­drew Dil­lon hops aboard as an ad­vi­sor to the com­pa­ny. An­halt joins the com­pa­ny af­ter a stint as VP of hu­man re­sources at Cel­gene and ex­pe­ri­ence from No­var­tis. For­mer­ly, An­toni served at Sanofi and at LEO Phar­ma as SVP of glob­al de­vel­op­ment. Hedrick joins with roles from BeiGene, Epizyme, Genen­tech and Phar­ma­cyclics un­der his belt. Hoey, a Mer­ck vet, most re­cent­ly served at Te­va Phar­ma­ceu­ti­cals.

→ Scor­ing $110 mil­lion in fi­nanc­ing this sum­mer to fight CNS dis­eases with two drugs in Phase II, Mar­cio Souza-led Prax­is Pre­ci­sion Med­i­cines has se­lect­ed Nicole Swee­ny as CCO and Alyssa Wyant as SVP, reg­u­la­to­ry and qual­i­ty. A Gen­zyme and Shire alum, Swee­ny was pre­vi­ous­ly hered­i­tary an­gioede­ma fran­chise head and US gen­er­al man­ag­er at Take­da, while Wyant jumps to Prax­is af­ter her time as a reg­u­la­to­ry ex­ec at Ery­Del. Ad­di­tion­al­ly, Kin­nate chair­man Dean Mitchell has been named chair­man of Prax­is’ board.

Yann Maz­abraud

→ Af­ter David Meek­er took over as CEO in Ju­ly, Rhythm Phar­ma­ceu­ti­cals’ lat­est per­son­nel move in­volves Yann Maz­abraud as their EVP, head of in­ter­na­tion­al. An 18-year Sanofi Gen­zyme vet, Maz­abraud had been CCO and head of in­ter­na­tion­al at Tre­vi Ther­a­peu­tics be­fore jump­ing to Rhythm, which tar­gets rare ge­net­ic obe­si­ty dis­or­ders.

→ A lit­tle more than a year af­ter their lead drug crashed in a Phase IIb tri­al for mod­er­ate to se­vere hidradeni­tis sup­pu­ra­ti­va, In­flaRx has re­tooled the C-suite a bit with Thomas Taap­ken as CFO and the pro­mo­tion of Jor­dan Zwick as chief strat­e­gy of­fi­cer. Taap­ken was pre­vi­ous­ly ex­ec­u­tive chair­man at Bel­gian biotech Im­cyse, and from 2011-16 was the CEO and CFO of Epige­nomics. Zwick comes to In­flaRx fol­low­ing sev­er­al years as ex­ec­u­tive di­rec­tor, head of strat­e­gy and busi­ness de­vel­op­ment at Sal­ix Phar­ma­ceu­ti­cals.

Ed Rock

→ On­col­o­gy start­up Part­ner Ther­a­peu­tics an­nounced two changes in the C-suite with Ed Rock as CMO and co-founder De­ba­sish Roy­chowd­hury slip­ping in­to the role of CTO. A for­mer med­ical di­rec­tor at GSK, Rock rolls in­to PTx af­ter 3 years as VP of clin­i­cal re­search and clin­i­cal project leader at Macro­Gen­ics. Roy­chowd­hury helped launch Part­ner Ther­a­peu­tics in ear­ly 2018 with CEO Robert Mul­roy and has Big Phar­ma ex­pe­ri­ence with Eli Lil­ly, GSK and Sanofi.

→ Health tech com­pa­ny El­e­ment Sci­ence has named Zu­bin Eapen as CMO. Eapen, a prac­tic­ing car­di­ol­o­gist, comes to the com­pa­ny with ex­pe­ri­ence from ex­ec roles at The An­them Com­pa­niesCare­More Health sub­sidiary, Health­Core and Pat­tern Health Tech­nolo­gies.

Nad­er Youssef

→ Lu­ca Santarel­li’s start­up, Vec­tivBio — a spin­out of Ther­a­chon that launched in Jan­u­ary with $35 mil­lion in fi­nanc­ing — has snagged Nad­er Youssef as SVP and head of glob­al clin­i­cal de­vel­op­ment and med­ical af­fairs. Most re­cent­ly, Youssef served as VP of clin­i­cal de­vel­op­ment at Pas­sage Bio and CMO at Nu­trinia. In ad­di­tion, he’s held a role as ex­ec­u­tive di­rec­tor of GI glob­al clin­i­cal de­vel­op­ment and med­ical af­fairs for NPS Phar­ma­ceu­ti­cals (ac­quired by Shire in 2015).

MEI Phar­ma, which snapped up $100 mil­lion up­front from Ky­owa Kirin in April for PI3Kδ in­hibitor ME-401, has ap­point­ed Bri­an Powl as their SVP, mar­ket­ing. Powl logged 9 years at Cel­gene in a num­ber of mar­ket­ing roles, in­clud­ing VP, glob­al com­mer­cial CAR-T lead in his last 2 years, and he was al­so at No­var­tis On­col­o­gy from 2006-11.

Julie Car­retero

→ Flag­ship-backed and Sim­ba Gill-led Evelo Bio­sciences, which is test­ing their lead an­ti-in­flam­ma­to­ry drug EDP1815 as a Covid-19 treat­ment, has named No­var­tis vet Julie Car­retero chief peo­ple of­fi­cer. Car­retero spent 17 years at the Swiss phar­ma gi­ant, ris­ing to as­sis­tant di­rec­tor, hu­man re­sources. Her most re­cent post was at man­u­fac­tur­ing com­pa­ny FXI Cor­po­ra­tion as their chief hu­man re­sources of­fi­cer.

Voy­ager Ther­a­peu­tics, the com­pa­ny that Ab­b­Vie broke a neu­ro R&D pact with back in Au­gust, has wel­comed Michelle Quinn Smith as chief hu­man re­sources of­fi­cer. Smith joins the com­pa­ny with ex­pe­ri­ence from Flag­ship Pi­o­neer­ing, Take­da and Gen­zyme (lat­er Sanofi) un­der her belt. In ad­di­tion, Genen­tech vet Nan­cy Vi­tale will be join­ing the com­pa­ny as an in­de­pen­dent di­rec­tor to its board of di­rec­tors. Dur­ing her 13 year stint at Genen­tech, Vi­tale served as SVP and chief hu­man re­source of­fi­cer.

Kel­lie Sears

AskBio, an AAV gene ther­a­py out­fit in the Re­search Tri­an­gle area of North Car­oli­na, has called up­on Kel­lie Sears to be chief hu­man re­sources of­fi­cer. Af­ter a 13-year run at Pfiz­er in HR ser­vices, Sears had been at Al­ler­gan since 2012, where she was pro­mot­ed last year to SVP and chief hu­man re­sources of­fi­cer.

→ Tus­sling with heavy hit­ters like J&J/Ar­row­head, GSK/Io­n­is and Vir/Al­ny­lam in the RNAi game for hep B, Lex­ing­ton, MA-based Dicer­na has brought in Ling Zeng as their chief le­gal of­fi­cer and sec­re­tary. In keep­ing with the theme of No­var­tis vets, she heads to Dicer­na af­ter a 3-year spell as the Big Phar­ma’s deputy head of the le­gal M&A group.

An­tho­ny Wa­claws­ki

An­tho­ny Wa­claws­ki, who gave more than 35 years to Bris­tol My­ers Squibb in a num­ber of ca­pac­i­ties, has set­tled in as EVP, glob­al head of reg­u­la­to­ry af­fairs at Brain­Storm, an adult stem cell ther­a­py de­vel­op­er for ALS and oth­er neu­ro­ge­net­ic dis­eases. When Wa­claws­ki left BMS, he was the Big Phar­ma’s VP and head, reg­u­la­to­ry and phar­ma­ceu­ti­cal sci­ences, car­dio­vas­cu­lar, im­muno­sciences, fi­bro­sis, and ge­net­i­cal­ly-de­fined dis­eases.

Christo­pher Mor­ri­son has tak­en on the role of VP, process sci­ence at Cal­i­for­nia gene ther­a­py play­er Ad­verum Biotech­nolo­gies, which showed pos­i­tive Phase I da­ta for pa­tients with wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD) in May. Pri­or to Ad­verum, Mor­ri­son was se­nior di­rec­tor, bio­phar­ma­ceu­ti­cal de­vel­op­ment at ApicBio Ther­a­peu­tics and se­nior di­rec­tor, CMC op­er­a­tions at Gem­i­ni Ther­a­peu­tics.

Cristi­na Csim­ma

Cristi­na Csim­ma has be­come chair of the board of di­rec­tors at Finnish biotech Foren­do Phar­ma, whose lead pro­gram fo­cus­es on en­dometrio­sis. Csim­ma al­so chairs the board at Car­away Ther­a­peu­tics.

→ Pfiz­er vet Pol­ly Mur­phy has been added to the board of di­rec­tors at Jean Pierre Som­ma­dos­si-led Atea Phar­ma­ceu­ti­cals. Mur­phy has just been named CBO at Uro­Gen.

Ele­na Ridloff

Aca­dia Phar­ma­ceu­ti­cals EVP and CFO Ele­na Ridloff joins Kro­nos Bio as a mem­ber of their board of di­rec­tors and will chair the au­dit com­mit­tee. Else­where, Ridloff has been VP of in­vestor re­la­tions at Alex­ion.

→ Macro­Gen­ics chair­man Paulo Cos­ta has made his way to the board of di­rec­tors at in­fec­tious and in­flam­ma­to­ry dis­ease biotech CorMedix. The for­mer chair­man of Amylin Phar­ma­ceu­ti­cals was pres­i­dent of No­var­tis from 2005 un­til his re­tire­ment in 2008.

Lau­ra Hamill

Lau­ra Hamill has hopped on the board of di­rec­tors at Ac­celeron, armed with pos­i­tive da­ta that have boost­ed ex­ecs’ con­fi­dence in so­tater­cept. The Am­gen and Gilead vet is al­so a board mem­ber at Y-mAbs and Anap­tys­Bio.

Ve­r­alox Ther­a­peu­tics has named the CEO of Pal­la­dio Bio­sciences Alex Mar­tin as chair­man of its board of di­rec­tors. Mar­tin joins with ex­pe­ri­ence run­ning Realm Ther­a­peu­tics as CEO and stints at In­ter­cept Phar­ma­ceu­ti­cals, BioX­ell and No­var­tis.

Ar­a­vive has ush­ered Michael Rogers on­to its board of di­rec­tors. Rogers most re­cent­ly served as CFO at Aer­pio Phar­ma­ceu­ti­cals and has pre­vi­ous­ly served in roles at Acor­da Ther­a­peu­tics and In­de­vus Phar­ma­ceu­ti­cals (ac­quired by En­do Phar­ma­ceu­ti­cals) among oth­ers. He cur­rent­ly sits on the board of di­rec­tors for Ake­bia Ther­a­peu­tics.

Natasha Gior­dano has been elect­ed to the board of di­rec­tors at Bed­min­ster, NJ-based Mati­nas Bio­Phar­ma, with its lead an­ti-fun­gal can­di­date MAT2203 in a Phase II study. Gior­dano has helmed PLx Phar­ma since Jan­u­ary 2016.

John Hous­ton

→ Mary­land-based im­muno-on­col­o­gy biotech NextCure has wel­comed John Hous­ton to their board of di­rec­tors. The Bris­tol My­ers Squibb vet has been pres­i­dent and CEO of Arv­inas since 2017.

F-star Ther­a­peu­tics CEO Eliot Forster gets a seat at the board of di­rec­tors with Im­mat­ics. The Ger­man T cell im­munother­a­py play­er merged with blank check com­pa­ny Arya Ven­tures and se­cured $252 mil­lion in fund­ing.

Bud Brigham

→ Austin im­muno-on­col­o­gy out­fit Perseus Hold­ings has an­nounced the ad­di­tion of Ben “Bud” Brigham to their board of di­rec­tors. Brigham is al­so chair­man of Brigham Ex­plo­ration, An­them Ven­tures, Brigham Min­er­als and At­las Sand.

Cy­dan co-founder and CEO Chris Adams has jumped on the board of di­rec­tors at Avice­da Ther­a­peu­tics, which is de­vel­op­ing gly­co-im­mune ther­a­peu­tics (GITs). Nan­cy Thoma­son, EVP and CFO of HAP In­vest­ment Group, is al­so new to the board.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Lat­est news on Pfiz­er's $3B+ JAK1 win; Pacts over M&A at #JPM22; 2021 by the num­bers; Bio­gen's Aduhelm reck­on­ing; The sto­ry of sotro­vimab; 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.

For those of you who attended #JPM22 in any shape or form, we hope you had a fruitful time. Regardless of how you spent the past hectic week, may your weekend be just what you need it to be.

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A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Back in the fall of 2020, newly crowned Pfizer chief Albert Bourla confidently put their JAK1 inhibitor abrocitinib at the top of the list of blockbuster drugs in the late-stage pipeline with a $3 billion-plus peak sales estimate.

Since then it’s been subjected to serious criticism for the safety warnings associated with the class, held back by a cautious FDA and questioned when researchers rolled out a top-line boast that their heavyweight contender had beaten the champ in the field of atopic dermatitis — Dupixent — in a head-to-head study.

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Robert Califf, FDA commissioner nominee (Graeme Sloan/Sipa USA/Sipa via AP Images)

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Rob Califf’s second confirmation process as FDA commissioner is already much more difficult than his near unanimous confirmation under the Obama administration.

The Senate Health Committee on Thursday voted 13-8 in favor of advancing Califf’s nomination to a full Senate vote. Several Democrats voted against Califf, including Sen. Bernie Sanders and Sen. Maggie Hassan. Several other Democrats who aren’t on the committee, like West Virginia’s Joe Manchin and Ed Markey of Massachusetts, also said Thursday that they would not vote for Califf. Markey, Hassan and Manchin all previously expressed reservations about the prospect of Janet Woodcock as an FDA commissioner nominee too.

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Michel Vounatsos, Biogen CEO (World Economic Forum/Ciaran McCrickard)

Bio­gen vows to fight CM­S' draft cov­er­age de­ci­sion for Aduhelm be­fore April fi­nal­iza­tion

Biogen executives made clear in an investor call Thursday they are not preparing to run a new CMS-approved clinical trial for their controversial Alzheimer’s drug anytime soon.

As requested in a draft national coverage decision from CMS earlier this week, Biogen and other anti-amyloid drugs will need to show “a meaningful improvement in health outcomes” for Alzheimer’s patients in a randomized, placebo-controlled trial to get paid for their drugs, rather than just the reduction in amyloid plaques that won Aduhelm its accelerated approval in June.

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CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-owner of a Florida-based clinical research site pleaded guilty to lying to an FDA investigator during a 2017 inspection, revealing that she falsely portrayed part of a GlaxoSmithKline pediatric asthma study as legitimate, when in fact she knew that certain data had been falsified, the Department of Justice said Wednesday.

Three other employees — Yvelice Villaman Bencosme, Lisett Raventos and Maytee Lledo — previously pleaded guilty and were sentenced in connection with falsifying data associated with the trial at the CRO Unlimited Medical Research.

Susan Galbraith, AstraZeneca EVP, Oncology R&D

Can­cer pow­er­house As­traZeneca rolls the dice on a $75M cash bet on a buzzy up­start in the on­col­o­gy field

After establishing itself in the front ranks of cancer drug developers and marketers, AstraZeneca is putting its scientific shoulder — and a significant amount of cash — behind the wheel of a brash new upstart in the biotech world.

The pharma giant trumpeted news this morning that it is handing over $75 million upfront to ally itself with Scorpion Therapeutics, one of those biotechs that was newly birthed by some top scientific, venture and executive talent and bequeathed with a fortune by way of a bankroll to advance an only hazily explained drug platform. And they are still very much in the discovery and preclinical phase.

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‘Skin­ny la­bels’ on gener­ics can save pa­tients mon­ey, re­search shows, but re­cent court de­ci­sions cloud fu­ture

New research shows how generic drug companies can successfully market a limited number of approved indications for a brand name drug, prior to coming to market for all of the indications. But several recent court decisions have created a layer of uncertainty around these so-called “skinny” labels.

While courts have generally allowed generic manufacturers to use their statutorily permitted skinny-label approvals, last summer, a federal circuit court found that Teva Pharmaceuticals was liable for inducing prescribers and patients to infringe GlaxoSmithKline’s patents through advertising and marketing practices that suggested Teva’s generic, with its skinny label, could be employed for the patented uses.

A patient in Alaska receiving an antibody infusion to prevent Covid hospitalizations in September. All but one of these treatments has been rendered useless by Omicron (Rick Bowmer/AP Images)

How a tiny Swiss lab and two old blood sam­ples cre­at­ed one of the on­ly ef­fec­tive drugs against Omi­cron (and why we have so lit­tle of it)

Exactly a decade before a novel coronavirus broke out in Wuhan, Davide Corti — a newly-minted immunologist with frameless glasses and a quick laugh — walked into a cramped lab on the top floor of an office building two hours outside Zurich. He had only enough money for two technicians and the ceiling was so low in parts that short stature was a job requirement, but Corti believed it’d be enough to test an idea he thought could change medicine.

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