With Glax­o­SmithK­line in the rearview mir­ror, Ab­bas Hus­sain is ready to lead a biotech of his own; Doug Tre­co scores first CEO job since Ra Phar­ma buy­out

Ab­bas Hus­sain

Ab­bas Hus­sain was once con­sid­ered to be a top can­di­date to take An­drew Wit­ty’s place as CEO of Glax­o­SmithK­line in 2016. When the job was ul­ti­mate­ly giv­en to Em­ma Walm­s­ley — who has been in her own spots of both­er re­cent­ly — Hus­sain quit as GSK’s glob­al pres­i­dent of phar­ma­ceu­ti­cals and vac­cines in Jan­u­ary 2017. Four years lat­er, Hus­sain gets be­hind the CEO wheel at Swiss-based Vi­for Phar­ma, which has a PDU­FA date of Aug. 23 with its Carapart­nered drug Ko­r­su­va for pru­ri­tis in he­modial­y­sis pa­tients. Hus­sain of­fi­cial­ly takes over for the de­part­ing Ste­fan Schulze a week be­fore that date on Aug. 16. Schulze had been in charge at Vi­for since March 2020 and is leav­ing for per­son­al rea­sons.

In be­tween GSK and Vi­for, Hus­sain has been a se­nior part­ner at C-Bridge Cap­i­tal and held seats on the board of di­rec­tors at CSL, Te­va Phar­ma­ceu­ti­cals and Cochlear.

Doug Tre­co

→ What’s next for Doug Tre­co af­ter UCB ponied up $2.5 bil­lion in 2019 to buy the com­pa­ny he co-found­ed, Ra Phar­ma­ceu­ti­cals? An­oth­er crack at lead­ing a biotech.

Tre­co re­places found­ing CEO Alex Leech at start­up Alchemab Ther­a­peu­tics, which in April pulled in $82 mil­lion from a Se­ries A round and is de­vel­op­ing an an­ti­body ther­a­py for Hunt­ing­ton’s while team­ing up with As­traZeneca on prostate can­cer re­search. Tre­co co-found­ed Ra Phar­ma in 2008 with Palleon CEO Jim Brod­er­ick, and he al­so co-found­ed Tran­skary­ot­ic Ther­a­pies, pur­chased by Shire in 2005.

Ben Thorner sig­naled on Twit­ter this week that he is leav­ing Mer­ck:

Thorner’s de­par­ture is rep­re­sen­ta­tive of an on­go­ing chang­ing of the guard at Mer­ck in which CEO Ken Fra­zier of­fi­cial­ly pass­es the ba­ton to Robert Davis this com­ing Thurs­day. Dean Li has suc­ceed­ed Roger Perl­mut­ternow the CEO of Eikon — as the phar­ma gi­ant’s R&D chief, and Car­o­line Litch­field took Davis’ old CFO job in April. Chief mar­ket­ing of­fi­cer Mike Nal­ly al­so broke away from Mer­ck to be­come CEO of Flag­ship-found­ed Gen­er­ate Bio­med­i­cines.

An­drew Hotchkiss

→ One of the 163 jobs that were slashed when Eli Lil­ly swooped in to buy Der­mi­ra — clos­ing up shop at the Men­lo Park, CA fa­cil­i­ty in the process — was that of CEO An­drew Hotchkiss. Get­ting up off the mat quick­ly, Hotchkiss is tak­ing con­trol of an­oth­er com­pa­ny: Draup­nir Bio, a Dan­ish car­dio­vas­cu­lar biotech fo­cused on PC­SK9. Be­fore lead­ing Der­mi­ra, Hotchkiss was chief com­mer­cial of­fi­cer and in­ter­im pre­de­ces­sor of CEO Bahi­ja Jal­lal at Im­muno­core and de­vot­ed more than two decades to Eli Lil­ly. The In­di­anapo­lis phar­ma bought Der­mi­ra for $1.1 bil­lion with its sights set on IL-13 in­hibitor le­brik­izum­ab to com­pete against Dupix­ent.

→ CSO Piet Wiger­inck is jump­ing ship at Gala­pa­gos months af­ter the com­pa­ny axed chunks of its pipeline fol­low­ing a re­jec­tion for Gilead-part­nered rheuma­toid arthri­tis drug fil­go­tinib. Wiger­inck joined the com­pa­ny in 2008 as SVP of de­vel­op­ment and be­came CSO in 2012. In his role, he over­saw the dis­cov­ery of nov­el tar­gets through to clin­i­cal proof-of-con­cept stud­ies, led the first clin­i­cal re­search in healthy vol­un­teers and was re­spon­si­ble for two Phase II pro­grams for fil­go­tinib, a JAK in­hibitor. Gala­pa­gos CMO Walid Abi-Saab will be tak­ing over ear­ly-stage de­vel­op­ment ac­tiv­i­ties, while Wiger­inck will be stay­ing with the com­pa­ny for an­oth­er five months as they search for a re­place­ment.

Pe­ter Bach

Memo­r­i­al Sloan Ket­ter­ing re­searcher Pe­ter Bach, an out­spo­ken tweet­mas­ter who’s spent a decade ar­dent­ly crit­i­ciz­ing the in­dus­try over drug pric­ing, has nabbed a spot at liq­uid biop­sy start­up Delfi Di­ag­nos­tics. Bach comes aboard as CMO of the Bal­ti­more-based biotech, which is look­ing for a bet­ter way to screen the blood for can­cer, af­ter spend­ing the last 23 years at Memo­r­i­al Sloan Ket­ter­ing, where he’s been di­rec­tor of the Cen­ter for Health Pol­i­cy and Out­comes. In a note to our Zachary Bren­nan af­ter the an­nounce­ment, Bach joked, “In my con­tract I am al­lowed 14 tweets per week but no threads.”

Celia Econo­mides

An­drew Allen’s Grit­stone bio has brought on Celia Econo­mides as CFO. A glob­al med­ical af­fairs vet­er­an at Bio­Marin, Econo­mides bids adieu to Kezar Life Sci­ences, where she was SVP, strat­e­gy and ex­ter­nal af­fairs. Else­where in her ca­reer she’s been Au­rinia’s VP, cor­po­rate and pub­lic af­fairs.

In oth­er Grit­stone de­vel­op­ments, Ro­man Ye­len­sky is on his way out as chief tech­nol­o­gy of­fi­cer “to co-found and lead a new start­up in the can­cer di­ag­nos­tics space, work­ing along­side a ma­jor health­care in­vestor,” per the re­lease. Ye­len­sky had been CTO since 2015 af­ter sev­er­al years at Foun­da­tion Med­i­cine. The Emeryville, CA biotech, which re­brand­ed from Grit­stone On­col­o­gy to its new name last month, has a sec­ond-gen Covid-19 vac­cine (CORAL) in a Phase I tri­al that is sup­port­ed by the NI­AID.

→ In a state of fail­ure-dri­ven flux with Fa­heem Has­nain tak­ing over the helm from Sheila Gu­jrathi and Luisa Salter-Cid off to an­oth­er CSO job at Flag­ship’s Pi­o­neer­ing Med­i­cines, the CMO po­si­tion that Jakob Dupont left in May 2020 at Gos­samer Bio hadn’t been filled yet. This week, it has. Gos­samer has pro­mot­ed Richard Aran­da, who came to the San Diego biotech three years ago and has been SVP and head of clin­i­cal de­vel­op­ment since 2019. Aran­da is an­oth­er Re­cep­tos alum — par for the course at Gos­samer — and he was glob­al clin­i­cal lead for Oren­cia at Bris­tol My­ers Squibb. Dur­ing his time at No­vo Nordisk from 2011-15, Aran­da served as VP of med­ical sci­ence and in­flam­ma­tion.

One last Gos­samer-re­lat­ed note: EVP of reg­u­la­to­ry af­fairs Caryn Pe­ter­son has tak­en a board seat at As­pen Neu­ro­science, where Has­nain is chair­man and Damien McDe­vitt took over as CEO in Jan­u­ary.

Shuyuan Yao

Al­lo­gene Over­land, a joint ven­ture in Chi­na that was es­tab­lished by Al­lo­gene and Hill­house-backed Over­land, has in­stalled Shuyuan Yao as CEO. Ed Zhang, Over­land’s COO/CBO and Al­lo­gene Over­land’s co-founder, had been in charge of the com­pa­ny on an in­ter­im ba­sis. Yao, who got his start as a sci­en­tist at Sang­amo, was CSO and head of re­search and tech­nol­o­gy de­vel­op­ment at WuXi Ad­vanced Ther­a­pies. A sim­i­lar joint ven­ture, Over­land AD­CT Bio­phar­ma, is in place with ADC Ther­a­peu­tics; Al­lo­gene Over­land’s goal is to spur the de­vel­op­ment of CAR-T ther­a­pies for pa­tients in Chi­na and through­out Asia, and while at WuXi, Yao was the dri­ving force be­hind its cell ther­a­py R&D busi­ness unit.

Ga­bor Veres

Ga­bor Veres has been pegged as CSO at oc­u­lar gene ther­a­py out­fit Vedere Bio II, the start­up that Cyrus Moza­yeni launched to the tune of a $77 mil­lion Se­ries A af­ter No­var­tis ac­quired the first Vedere Bio back in Oc­to­ber. Since 2019, Veres was head of gene ther­a­py re­search at Bio­Marin, which was dealt one of the more shock­ing CRLs last sum­mer with its he­mo­phil­ia A gene ther­a­py. Veres was VP of pre-clin­i­cal re­search at blue­bird bio from 2010-19, lead­ing projects on such drugs as Zyn­te­glo.

Leone Pat­ter­son

Ad­verum’s shares tum­bled sig­nif­i­cant­ly in April when a pa­tient lost vi­sion in one eye dur­ing its gene ther­a­py tri­al for di­a­bet­ic mac­u­lar ede­ma. Pres­i­dent, CFO and one-time CEO Leone Pat­ter­son re­signed yes­ter­day for the ever-pop­u­lar pur­suit of oth­er op­por­tu­ni­ties, leav­ing Christo­pher DeRespino — who’s been the CBO at Ad­verum since Feb­ru­ary — as act­ing CFO. DeRespino was ex­ec­u­tive di­rec­tor of busi­ness de­vel­op­ment dur­ing his eight years at Am­gen.

Christo­pher DeRespino

Mean­while, Pe­ter Soparkar has been pro­mot­ed to the COO slot af­ter join­ing Ad­verum as chief le­gal of­fi­cer in Oc­to­ber 2019. Soparkar was VP, as­so­ciate gen­er­al coun­sel dur­ing his 10-year tenure at Jazz Phar­ma­ceu­ti­cals.

→ Pro­tein degra­da­tion biotech Nurix Ther­a­peu­tics, which has on­go­ing col­lab­o­ra­tions with Gilead and Sanofi, has ap­point­ed Ste­fani Wolff COO and EVP, prod­uct de­vel­op­ment. Wolff just nabbed a board seat at Rain Ther­a­peu­tics and was chief de­vel­op­ment of­fi­cer at Prin­cip­ia Bio­phar­ma be­fore land­ing these dual roles. Af­ter start­ing her ca­reer with Eli Lil­ly in sales and mar­ket­ing, Wolff would then spend 13 years in on­col­o­gy and im­munol­o­gy at Genen­tech, and she would lat­er be VP of de­vel­op­ment and glob­al project team leader for Onyx Phar­ma­ceu­ti­cals.

Elaine Caugh­ey

→ While we’re on a roll with pro­tein degra­da­tion com­pa­nies, Nel­lo Main­olfi-led Kymera Ther­a­peu­tics out of Wa­ter­town, MA, has se­lect­ed Elaine Caugh­ey as CBO. Caugh­ey leaves Flag­ship-found­ed Cyg­nal Ther­a­peu­tics, where she was CBO for Pearl Huang and joined the team just af­ter its Oc­to­ber 2019 launch. Be­fore Cyg­nal, she was head of strat­e­gy and op­er­a­tions, glob­al mar­ket ac­cess to close out her six-plus years at Bio­gen. Kymera fol­lowed up its $102 mil­lion Se­ries C round in March 2020 with an IPO to­tal­ing near­ly $200 mil­lion.

Glenn Re­icin

Glenn Re­icin has tak­en on CFO re­spon­si­bil­i­ties at food al­ler­gy play­er Al­ladapt — co-found­ed by Kari Nadeau and CEO Ash­ley Dom­bkows­ki in 2018 — in a move that comes af­ter two years as CFO at Sig­ilon Ther­a­peu­tics. Re­icin has al­so been pres­i­dent of Grey­lock Bio­med­ical Ad­vi­sors and man­ag­ing di­rec­tor at Mor­gan Stan­ley. He is the broth­er of Alise Re­icin, the for­mer Mer­ck and Cel­gene ex­ec who is cur­rent­ly pres­i­dent and CEO of Tec­ton­ic Ther­a­peu­tic.

Jes­si­ca Gross­man

→ When IgGenix — an­oth­er Nadeau biotech — emerged from stealth with a mod­est $10 mil­lion round, Bruce Hi­ron­a­ka told our Max Gel­man that he didn’t in­tend to stay CEO for long. True to his word, Hi­ron­a­ka steps aside as Jes­si­ca Gross­man takes com­mand of the South San Fran­cis­co food al­ler­gy play­er. Gross­man has pre­vi­ous­ly been CEO at Med­i­cines360 and she’s on the board of Daré Bio­science that’s chaired by William Rastet­ter, who’s al­so chair­man of Grail, Neu­ro­crine and Fate.

→ With Adam Walsh step­ping in as CFO of New­port Beach, CA-base­da eye dis­ease biotech jCyte, the crew keeps grow­ing af­ter Shan­non Blalock hit the scene as CEO along with a new CCO, gen­er­al coun­sel and oth­er ex­ecs. Walsh has been CFO for the last year at Cat­alyt­ic Life Sci­ences fol­low­ing near­ly five years at Stifel as man­ag­ing di­rec­tor and se­nior an­a­lyst, biotech­nol­o­gy eq­ui­ty re­search. In Ju­ly 2020, jCyte un­veiled pos­i­tive Phase IIb da­ta for its re­tini­tis pig­men­tosa ther­a­py, called jCell.

→ De­vel­op­ing a gut mi­cro­bio­me ther­a­py for en­teric hy­per­ox­aluria, South San Fran­cis­co’s Novome Biotech­nolo­gies has ap­point­ed Lachy McLean CMO. Be­fore his most re­cent head of re­search post at Tra­vere (re­brand­ed from the Mar­tin Shkre­li days of Retrophin), McLean had a 12-year tenure at Take­da, mak­ing the climb to VP and glob­al head of trans­la­tion­al clin­i­cal sci­ence im­munol­o­gy.

Michael Han­na

→ Back in Sep­tem­ber we men­tioned that Ve­r­alox Ther­a­peu­tics had named Pal­la­dio Bio­sciences CEO Alex Mar­tin chair­man of the board, and the Fred­er­ick, MD biotech has since added Big Phar­ma vet Michael Han­na to its team as CMO. From 2004-16, Han­na was in­volved in glob­al clin­i­cal re­search at Bris­tol My­ers, pre­dom­i­nant­ly as the clin­i­cal lead for the block­buster Eliquis. Ve­r­alox’s lead drug, VLX-1005, is geared to­ward those with he­parin-in­duced throm­bo­cy­tope­nia (HIT).

→ We told you in De­cem­ber about John Maxwell leav­ing his CFO post at New Jer­sey-based Aque­s­tive Ther­a­peu­tics. His suc­ces­sor, Ernie Toth, has been fill­ing the job on an in­ter­im ba­sis, but as of this week he’s in­ter­im no more and has al­so been named an SVP. Toth’s CFO ex­pe­ri­ence in­cludes JHP Phar­ma­ceu­ti­cals (now Par Ster­ile Prod­ucts), Aris­Glob­al and EHE Health.

→ As of April 14, Alek­sey Krylov has got­ten sit­u­at­ed as CFO of NK-fo­cused Cy­toIm­mune Ther­a­peu­tics, pre­ced­ing Co­di­ak CEO Doug Williams’ ap­point­ment as chair­man. Krylov, the founder and man­ag­ing di­rec­tor at Ftera Ad­vi­sors, has been an in­ter­im or act­ing CFO on mul­ti­ple oc­ca­sions, in­clud­ing with Sel­l­as Life Sci­ences and re­Vi­sion Ther­a­peu­tics.

Sta­cy Cline Amin

→ Adding to the num­ber of gov­ern­ment of­fi­cials who have filed in­to the firm this year, Sta­cy Cline Amin will co-lead the FDA reg­u­la­to­ry and com­pli­ance prac­tice at Mor­ri­son & Fo­er­ster as a part­ner in life sci­ences in health­care. Be­fore join­ing Mo­Fo, Amin was the FDA’s chief coun­sel in the Trump ad­min­is­tra­tion from 2018-21 and deputy chief coun­sel for the HHS.

Kevin Schutz has jumped on board at Tiziana Life Sci­ences — fo­cused on the ver­i­ta­ble grab bag of on­col­o­gy, neu­rol­o­gy, in­flam­ma­tion and in­fec­tious dis­eases— as VP of reg­u­la­to­ry af­fairs. Schutz’s in­volve­ment with­in the reg­u­la­to­ry realm ex­tends to oth­er gigs at Ipsen, Amarin, In­smed, and more re­cent­ly with Os­mot­i­ca Phar­ma­ceu­ti­cals.

→ Penn­syl­va­nia biotech Ocu­gen, which is work­ing on gene ther­a­pies for eye dis­eases and co-de­vel­op­ing a Covid-19 vac­cine called Co­v­ax­in, has wel­comed Ken In­chausti as head, in­vestor re­la­tions & com­mu­ni­ca­tions. From 2004-10, In­chausti held com­mu­ni­ca­tions and me­dia re­la­tions posts at Glax­o­SmithK­line, and he then rose to se­nior di­rec­tor, cor­po­rate com­mu­ni­ca­tions dur­ing his sub­se­quent 10+ years at No­vo Nordisk.

Greg Sukay

→ With its top­i­cal rof­lu­mi­last cream for­mu­la­tion far­ing well in Phase III tri­als for plaque pso­ri­a­sis, Ar­cutis has ush­ered in Greg Sukay as VP of man­u­fac­tur­ing and process tech­nolo­gies. This new door opens for Sukay af­ter a 22-year run with Am­gen that took him to Asia as plant man­ag­er and ex­ec­u­tive di­rec­tor of Am­gen Sin­ga­pore and that end­ed as ex­ec­u­tive di­rec­tor of Am­gen Con­tract Man­u­fac­tur­ing.

→ That’s not the on­ly Ar­cutis-re­lat­ed news. The com­pa­ny’s CEO, Frank Watan­abe, has been elect­ed to the board of di­rec­tors at Ang­ie You’s Amu­nix. Watan­abe be­came the chief ex­ec­u­tive at Ar­cutis in 2017 af­ter be­ing named pres­i­dent a year ear­li­er.

Scott Braun­stein

Mar­i­nus Phar­ma­ceu­ti­cals CEO Scott Braun­stein is grab­bing a seat on CRISPR genome-edit­ing Cari­bou Bio­sciences‘ board of di­rec­tors. Pri­or to his cur­rent role at Mar­i­nus, Braun­stein was with Ais­ling Cap­i­tal and Paci­ra Phar­ma­ceu­ti­cals. Braun­stein al­so sits on the boards of Treve­na and Con­stel­la­tion Phar­ma­ceu­ti­cals.

→ Flag­ship epi­ge­net­ic pro­gram­ming start­up Omega Ther­a­peu­tics has a seat ready for Luke Be­shar on the board of di­rec­tors. The ex-CFO of NPS Phar­ma­ceu­ti­cals, Be­shar is al­so the chair­man of Pro­tara and is on the boards of Re­genxbio and Tril­li­um.

Mar­cio Souza has joined the board of di­rec­tors at Austin, TX-based Ae­glea Bio­Ther­a­peu­tics, which is in Phase III with its lead drug for arginase-1 de­fi­cien­cy. Souza, the pres­i­dent and CEO of Prax­is Pre­ci­sion Med­i­cines, is for­mer­ly the COO of PTC Ther­a­peu­tics.

Nis­han de Sil­va

→ Langer-backed Se­lec­ta Bio­sciences has opened a spot for Nis­han de Sil­va on its board of di­rec­tors. Cur­rent­ly, de Sil­va is the CEO and di­rec­tor of AFYX Ther­a­peu­tics. Pri­or to that, de Sil­va served as COO and di­rec­tor of Po­sei­da Ther­a­peu­tics and CFO and VP of fi­nance and strat­e­gy at Lig­and Phar­ma­ceu­ti­cals.

→ San Fran­cis­co-based Spruce Bio­sciences has reeled in Kirk Ways to its board of di­rec­tors. Ways re­cent­ly served as CMO of Nu­ve­lu­tion Phar­ma and pri­or to that role was head­ing drug de­vel­op­ment units at John­son & John­son’s phar­ma­ceu­ti­cal re­search and de­vel­op­ment group. In ad­di­tion, Ways has had stints at Bio­S­tra­tum, Aven­tis and Lil­ly Re­search Lab­o­ra­to­ries.

Son­ja Nel­son

→ Fort Laud­erdale-based medtech Mo­tus GI has brought on Son­ja Nel­son to its board of di­rec­tors and as chair of the au­dit com­mit­tee. Cur­rent­ly, Nel­son is the SVP, fi­nance at Im­mu­ni­ty­Bio, fol­low­ing the merg­er of the com­pa­ny with Nan­tK­west — where she served as CFO for sev­er­al years. Pri­or to Nan­tk­west, Nel­son was with Alt­heaDx and Ca­dence Phar­ma­ceu­ti­cals.

Ve­rastem On­col­o­gy, which in May won a break­through nod for its com­bo ther­a­py in ovar­i­an can­cer, has made the ad­di­tions of Paul Bunn and Les­ley Solomon to its board of di­rec­tors. Bunn is a pro­fes­sor of med­i­cine and James Dud­ley chair in can­cer re­search, di­vi­sion of med­ical on­col­o­gy at the Uni­ver­si­ty of Col­orado School of Med­i­cine. Pre­vi­ous­ly, Bunn served in roles at the US Na­tion­al Can­cer In­sti­tute-Navy Med­ical On­col­o­gy branch, Uni­ver­si­ty of Col­orado Can­cer Cen­ter and In­ter­na­tion­al As­so­ci­a­tion for the Study of Lung Can­cer (IASLC) among oth­ers.

Mean­while, Solomon is a ven­ture chair at Re­design Health. Pri­or to her role at Re­design, Solomon was the chief in­no­va­tion of­fi­cer at Dana-Far­ber Can­cer In­sti­tute.

Ab­b­Vie’s CD47 part­ner I-Mab has re­cruit­ed An­drew Zhu to its sci­en­tif­ic ad­vi­so­ry board. Zhu hops aboard the Chi­nese biotech as a pro­fes­sor of med­i­cine at Har­vard Med­ical School, di­rec­tor emer­i­tus of liv­er can­cer re­search at Mass­a­chu­setts Gen­er­al Hos­pi­tal, CSO of Ji­ahui Health and di­rec­tor of Ji­ahui In­ter­na­tion­al Can­cer Cen­ter (JICC) in Shang­hai.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

Jim Wil­son start­up Pas­sage Bio plugs in CFO, CMO; Till­man Gern­gross nabs a COO fa­mil­iar with Covid-19 fight at Pfiz­er as Ada­gio files for IPO

→ Back in May, Passage Bio CFO Richard Morris and CMO Gary Romano left within days of each other, but this week the gene therapy player has found their replacements, along with a chief commercial officer. Simona King, a 19-year Bristol Myers Squibb vet in finance, becomes CFO on Aug. 23 after a quick stop in the same post at Tmunity Therapeutics and a year at Emergent BioSolutions. CMO Mark Forman gets started a week from today and was recently VP of translational medicine at Acadia Pharmaceuticals, preceded by 11 years at Merck. And Maria Törnsén, who got the ball rolling as CCO this week, had been Sarepta’s SVP, general manager, US.

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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Al Sandrock, Biogen R&D chief (Biogen via YouTube)

Bio­gen has a shaky end to H1 with a $542M write-off adding to its woes — but an­a­lysts see big rev­enue ahead for Aduhelm

All eyes at Biogen’s Q2 earnings call Thursday were on Aduhelm, but investors also got a glimpse of what Biogen would have faced had the FDA not opted to approve their controversial Alzheimer’s drug.

That glimpse, revealing a combination of declining sales, growing competition and failed medicines, underscores the stakes of the big biotech’s Aduhelm efforts, as execs punch back at the criticism they’ve engendered in the political and medical world and vigorously pushes its sales staff to roll out the drug as fast as possible.

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Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.