Two months af­ter ink­ing a SPAC deal, Ren­o­va­cor taps new CMO; Cure­Vac reels in a new de­vel­op­ment chief from Mer­ck KGaA

Marc Sem­i­gran

Marc Sem­i­gran was at sleep­away camp in Hopewell Junc­tion, NY, when Neil Arm­strong took the first steps on the moon. He packed in­to a so­cial hall with a cou­ple of hun­dred kids whose eyes were glued to one small, stat­icky, black-and-white tele­vi­sion as Arm­strong de­scend­ed the lad­der.

It sparked an in­ter­est in physics for Sem­i­gran whose fo­cus lat­er turned to med­i­cine be­cause he want­ed to help peo­ple. That, and “I’m prob­a­bly too tall, I don’t think I would have made it as an as­tro­naut,” he quipped.

He went on to Har­vard Med­ical School, then an in­tern­ship and res­i­den­cy at the renowned Mass­a­chu­setts Gen­er­al Hos­pi­tal. His car­di­ol­o­gy work there even­tu­al­ly led to a gig as CMO of MyoKar­dia, where he stayed un­til the com­pa­ny was bought out by Bris­tol My­ers Squibb for a whop­ping $13.1 bil­lion last year. And now, he’s tak­ing the same role at gene ther­a­py-fo­cused Ren­o­va­cor, just as the com­pa­ny pre­pares to go pub­lic on the back of a SPAC.

“Some­thing that re­al­ly re­as­sured me about my de­ci­sion was that we will have the funds to be able to car­ry out the sci­en­tif­ic mis­sion,” he said. Up­on clos­ing its deal with the blank-check com­pa­ny Chardan Health­care Ac­qui­si­tion 2 Corp, Ren­o­va­cor is set to pock­et gross pro­ceeds of up to $116 mil­lion.

Sem­i­gran joined MyoKar­dia back in 2016, where he over­saw Phase I and II stud­ies and the de­sign of reg­is­tra­tional stud­ies, worked with reg­u­la­tors, and helped file the NDA for mava­camten — MyoKar­dia’s drug for ob­struc­tive car­diomy­opa­thy. In 2019, Sem­i­gran was pro­mot­ed to se­nior VP of med­ical sci­ences. The FDA set a de­ci­sion date of Jan. 28, 2022, for mava­camten, the same year that Ren­o­va­cor is hop­ing to get IND clear­ance for REN-001, its gene ther­a­py for BAG3-as­so­ci­at­ed di­lat­ed car­diomy­opa­thy (DCM).

“It would be great,” he said, if one of his drugs gets ap­proved in the same year that an­oth­er en­ters the clin­ic.

“So many of our ther­a­pies for heart fail­ure re­al­ly ad­dress man­i­fes­ta­tions of heart fail­ure, rather than the pri­ma­ry un­der­ly­ing prob­lem,” Sem­i­gran said. “Dif­fer­en­ti­at­ing by cause is re­al­ly what we need to do with heart fail­ure…  Both REN-001 and mava­camten ad­dress very dif­fer­ent seg­ments of the heart fail­ure pop­u­la­tion, and we need them both.”

BAG3 pro­tein is ex­pressed pre­dom­i­nant­ly in the heart, where it plays a role in the main­te­nance of sar­com­eres, nor­mal­iza­tion of pro­tein qual­i­ty con­trol, in­hi­bi­tion of pro­grammed cell death, and re­spon­sive­ness to adren­er­gic sig­nals. BAG3 DCM has an av­er­age on­set at 38 years old, and a sur­vival rate of less than 50% five years af­ter dis­cov­ery.

“Cer­tain­ly, our first and pri­ma­ry tar­get is to ad­dress the pa­tients with the ge­net­ic mu­ta­tions in BAG3. But as we learn more from treat­ing these pa­tients, there may be the pos­si­bil­i­ty of ex­pan­sion to oth­er heart fail­ure pa­tients,” Sem­i­gran said, or even oth­er or­gans. — Nicole De­Feud­is

Klaus Ed­vard­sen

Cure­Vac, the run­ner up mR­NA com­pa­ny mak­ing a new vac­cine for Covid-19, has poached their new de­vel­op­ment chief from Mer­ck KGaA.

The Ger­man biotech re­port­ed it re­cruit­ed Mer­ck KGaA’s Klaus Ed­vard­sen for chief de­vel­op­ment of­fi­cer. Ed­vard­sen had been head of on­col­o­gy for the Ger­man Mer­ck, mak­ing him a good cul­tur­al fit with Cure­Vac. He had ear­li­er served a stint as head of on­col­o­gy de­vel­op­ment at As­traZeneca and had worked at GSK and Gen­mab be­fore that.

He has a tremen­dous back­ground, hav­ing led both busi­ness de­vel­op­ment and clin­i­cal re­search on a glob­al scale for sev­er­al high-pro­file bio­phar­ma­ceu­ti­cal com­pa­nies. His great breadth of knowl­edge and ex­per­tise in re­search and dif­fer­ent ther­a­peu­tic ar­eas will serve Cure­Vac well as it con­tin­ues to evolve from a re­search-ori­ent­ed biotech­nol­o­gy to a ful­ly in­te­grat­ed bio­phar­ma­ceu­ti­cal com­pa­ny,” ob­served Jean Stéphenne, chair­man of the su­per­vi­so­ry board of Cure­Vac. — John Car­roll

Nurix Ther­a­peu­tics is cel­e­brat­ing the ad­di­tion of its newest board mem­ber, and it’s reeled in a high-pro­file biotech CEO.

Clay Sie­gall

Clay Sie­gall of Seagen is hop­ping on­to the board, Nurix an­nounced this week, join­ing the pro­tein degra­da­tion play­er that’s se­cured part­ner­ships with Gilead and Sanofi. The move comes as Nurix is ex­pect­ed to launch clin­i­cal stud­ies for three prod­uct can­di­dates some­time be­fore the end of the year.

Sie­gall made his name by found­ing Seagen as Seat­tle Ge­net­ics way back in 1998, and has trans­formed it in­to one of the larg­er biotechs in the US. Un­der Sie­gall’s lead­er­ship, Seagen has shep­herd­ed three drugs past the fin­ish line with the po­ten­tial for a fourth in Oc­to­ber.

It’s pinned block­buster hopes on one of its drugs, the Nectin-4 tar­get­ing ther­a­py Pad­cev, which saw sales more than dou­ble to $69.8 mil­lion in the first quar­ter in 2021 com­pared to 2020.

Sie­gall him­self has made a pret­ty pen­ny as the com­pa­ny’s chief ex­ec­u­tive, pulling in a $16.5 mil­lion pay pack­age last year — a fig­ure that ap­proach­es some of the biggest names in phar­ma. It’s al­so the largest pack­age for any CEO in the state of Wash­ing­ton, ac­cord­ing to an As­so­ci­at­ed Press re­port.

Nurix, mean­while, is con­tin­u­ing to charge ahead with its pipeline. The pro­grams ex­pect­ed to hit Phase I stud­ies soon com­prise a small mol­e­cule de­grad­er of BTK called NX-5948, and with it, Nurix hopes to tar­get au­toim­mune dis­eases. There are al­so two lig­ase in­hibitors where Nurix is go­ing af­ter an im­muno-on­col­o­gy tar­get and tu­mor in­fil­trat­ing lym­pho­cytes, re­spec­tive­ly.

Their lead can­di­date is a dual de­grad­er of both BTK and Aio­los, a pro­tein tar­get of IMiD drugs, known as NX-2127. It re­cent­ly be­gan its own clin­i­cal tri­al, the first Nurix has launched.

In ad­di­tion to Nurix’s board, Sie­gall al­so serves on the boards of Ul­tragenyx and Wash­ing­ton Round­table, a lob­by­ist group com­pris­ing sev­er­al ex­ec­u­tives from the state. — Max Gel­man

Ronald Martell

→ Pri­vate plat­form com­pa­ny Mor­phim­mune has se­lect­ed Ronald Martell as the com­pa­ny’s new CEO and pres­i­dent. The new stint at the San Fran­cis­co-based com­pa­ny isn’t Martell’s first rodeo in the CEO chair. Martell was pre­vi­ous­ly run­ning gigs at Nu­ve­la­tion Phar­ma, Achieve Life Sci­ences, Se­vion and Neu­ro­gesX. Ad­di­tion­al­ly, Martell was co-founder and ex­ec­u­tive chair­man of In­dap­ta and Or­ca Bio. Ear­li­er in his ca­reer, Martell was with Genen­tech and Im­Clone Sys­tems, where he was mak­ing deals with Bris­tol My­ers Squibb and Mer­ck KGaA.

Ste­fan König, the for­mer Take­da VP and glob­al fran­chise head, in­flam­ma­to­ry bow­el dis­ease, has hopped in­to the CEO seat at George Med­i­cines. In his most re­cent role at Take­da, König was re­spon­si­ble for En­tyvio (vedolizum­ab). König’s ear­li­er roles at Take­da in­clud­ed re­gion­al man­ag­ing di­rec­tor for a clus­ter of coun­tries in Cen­tral and East­ern Eu­rope. In ad­di­tion, König spent 10 years in Mex­i­co and Latin Amer­i­ca work­ing in busi­ness and cor­po­rate de­vel­op­ment and mar­ket­ing for Mer­ck and No­var­tis.

Deci­bel Ther­a­peu­tics has added a new chair­man as it con­tin­ues a now-more-than-year­long piv­ot to gene ther­a­py and re­gen­er­a­tion.

William Car­son

The Cam­bridge biotech named William Car­son, for­mer CEO of Ot­su­ka Phar­ma­ceu­ti­cals, as chair. Car­son will serve as a de­layed re­place­ment for for­mer Bio­gen CEO George Scan­gos, a long­time col­league of Steve Holtz­man, Deci­bel’s for­mer chief ex­ec­u­tive. Deci­bel qui­et­ly dis­closed in their S-1 this Jan­u­ary that Scan­gos had re­signed from the board in June 2020, five months af­ter Holtz­man re­tired and the com­pa­ny shift­ed fo­cus.

Car­son, a psy­chi­a­trist, served on the board at Pre­vail be­fore its buy­out by Eli Lil­ly and is now on the boards at Saa­ma Tech­nolo­gies, An­nex­on, Ot­su­ka and Ex­ci­sion Bio­ther­a­peu­tics. His ap­point­ment comes amid a se­ries of changes Deci­bel has made to bur­nish its cre­den­tials, most re­cent­ly ex­pand­ing its sci­en­tif­ic ad­vi­so­ry board with a clutch of well-re­gard­ed gene ther­a­py and hear­ing ex­perts.

Patrick Flani­gan is hop­ping aboard Nan­cy Thorn­ber­ry’s gut-brain ax­is biotech Kally­ope as CFO. Flani­gan joins the crew from Ich­nos Sci­ences, where he al­so served as CFO. Flani­gan jump­start­ed his ca­reer at Gen­zyme, where he served as VP of in­vestor re­la­tions be­fore hop­ping over to Cel­gene as SVP.

Nanobi­otix has ush­ered in a new CFO two days pri­or to pre­sent­ing some pos­i­tive ear­ly da­ta at #AS­CO21 for their tu­mor-shrink­ing tech. Bart Van Rhi­jn, who joins the com­pa­ny af­ter a stint as CFO of Servi­er Phar­ma­ceu­ti­cals, will be suc­ceed­ing out­go­ing CFO Philippe Mauber­na. Pri­or to his role at Servi­er, Van Rhi­jn was with Price­wa­ter­house­C­oop­ers, Philips and Gal­der­ma. Ad­di­tion­al­ly, Van Rhi­jn has been ap­point­ed to the com­pa­ny’s ex­ec­u­tive board.

Mol­ly Gib­son

→ AI biotech Gen­er­ate Bio­med­i­cines has reeled in Mike No­haile as CSO. No­haile hails from Flag­ship Pi­o­neer­ing, where he served as op­er­at­ing part­ner. Pri­or to Flag­ship, No­haile was with Am­gen, where he served as SVP of strat­e­gy, com­mer­cial­iza­tion, and in­no­va­tion.

In ad­di­tion to No­haile’s ap­point­ment, Mol­ly Gib­son — who was hon­ored in our 2020 20 un­der 40 spe­cial — will be ex­pand­ing her role at Gen­er­ate, tack­ing on new re­spon­si­bil­i­ties as chief strat­e­gy and in­no­va­tion of­fi­cer. Pri­or to Gen­er­ate, Gib­son, who is a prin­ci­pal of Flag­ship Pi­o­neer­ing, led com­pu­ta­tion­al bi­ol­o­gy at Kalei­do Bio­sciences.

Valen­z­aBio — whose on­col­o­gy is­land of mis­fit toys snared $70 mil­lion in April — has waved in Gre­go­ry Keenan as CMO. Keenan joins the Bethes­da, MD-based team from Avro­bio, where he served as SVP, glob­al head of med­ical and drug safe­ty. Pri­or to that, he served in stints at As­traZeneca, Med­im­mune, Hu­man Genome Sci­ences and Cen­to­cor Or­tho­Biotech.

In ad­di­tion to Keenan’s ap­point­ment, the crew has al­so wel­comed CEO of Ri­bometrix Mike Solomon in­to the fold as part of its board of di­rec­tors. Solomon was a for­mer ven­ture part­ner of SV Health In­vestors; COO of Deci­bel Ther­a­peu­tics, and en­tre­pre­neur in res­i­dence at Third Rock Ven­tures among oth­er stints.

Michael MacLean

→What bet­ter way to prep for an IPO than adding a well-re­gard­ed CFO to your board? Verve Ther­a­peu­tics, Sekar Kathire­san’s car­dio­vas­cu­lar gene-edit­ing start­up, an­nounced they had named Michael MacLean, for­mer CFO of Avid­i­ty Bio­sciences, to its board. In ad­di­tion to Avid­i­ty, MacLean has al­so worked as CFO of PureTech and Io­n­is spin­out Akcea. Verve has pen­ciled in $100 mil­lion for their pub­lic of­fer­ing, al­though they are wide­ly ex­pect­ed to raise sig­nif­i­cant­ly more.

David Hung has re­cruit­ed a sup­ply chain ex­pert to en­sure that the can­cer drugs he’s de­vel­op­ing at Nu­va­tion Bio will be ready when­ev­er he needs them. As chief tech­ni­cal op­er­a­tions of­fi­cer, David Han­ley is tasked with over­see­ing every­thing from prod­uct de­vel­op­ment to man­u­fac­tur­ing, while al­so work­ing on com­mer­cial plan­ning with oth­er teams — in short, ded­i­cat­ed to prod­uct readi­ness at all stages, whether it be pre­clin­i­cal or mar­ket­ing. He joins from Ra­dius Health just as Nu­va­tion is push­ing a Phase I/II study of the lead can­di­date, which tar­gets CDK 2/4/6, and lin­ing up five oth­ers for the clin­ic.

Wayne God­frey

→ While aim­ing for an IPO af­ter com­ing off the press­es with a $1 bil­lion deal with Mer­ck, Janux Ther­a­peu­tics has se­lect­ed Wayne God­frey as CMO. God­frey comes from IGM Bio­sciences, where he served as VP of clin­i­cal de­vel­op­ment. Be­fore that, he was with Kite Phar­ma, Etubics, Gilead and Bavar­i­an-Nordic.

→ Be­lea­guered biotech On­cono­va Ther­a­peu­tics — which axed its high-risk MDS pro­gram af­ter an­oth­er PhI­II flop — has named Mark Gelder as CMO. Gelder hops aboard from El­e­var Ther­a­peu­tics, where he served in the same role. Pri­or to El­e­var, Gelder was work­ing with Pier­ian Bio­sciences, Ac­celo­vance, Heron Ther­a­peu­tics, Pfiz­er, Wyeth and Bay­er.

→ Launched by Fra­zier Health­care Part­ners last May with a $15 mil­lion Se­ries A, San Diego-based on­col­o­gy drug de­vel­op­er Lengo Ther­a­peu­tics has made Di­ana Haus­man CMO. Haus­man comes aboard af­ter a stint as CMO for Zymeworks. Pri­or to that, she served at Zy­mo­Ge­net­ics, Berlex and Im­munex. Haus­man’s ap­point­ment comes three weeks af­ter Lengo snagged the CEO of Velos­Bio Dave John­son as chair­man of the board.

Di­ana Haus­man

Evelo Bio­sciences has ap­point­ed Mark Plinio as CCO. Plinio comes to Evelo from Iron­wood Phar­ma­ceu­ti­cals, where he was CCO and SVP, mar­ket­ing and sales. Pri­or to his gig at Iron­wood, Plinio spent near­ly two decades at No­var­tis in a va­ri­ety of roles in­clud­ing head of der­ma­tol­ogy and rheuma­tol­ogy mar­ket­ing for Cosen­tyx.

JSR Life Sci­ences com­pa­ny Se­lex­is has named Roland Hoff­mann-Hecht as CBO. Hoff­mann-Hecht hails from Pol­phar­ma Bi­o­log­ics, where he was head of busi­ness de­vel­op­ment, CD­MO Eu­rope. Pri­or to that, he held roles at Hal­ix, BIO­ME­VA GmbH, CMC Bi­o­log­ics and Rentschler Biotech­nolo­gie GmbH.

Wan-Jen Hong

Blood can­cer play­er Ima­go Bio­sciences has ap­point­ed Wan-Jen Hong as CMO. Hong hails from Genen­tech, where she served as group med­ical di­rec­tor. Hong pre­vi­ous­ly was a clin­i­cal in­struc­tor in hema­tol­ogy at Stan­ford Uni­ver­si­ty School of Med­i­cine and is the cur­rent ad­junct clin­i­cal fac­ul­ty mem­ber in its di­vi­sion of hema­tol­ogy.

→ Af­ter emerg­ing from stealth mode last June with $118 mil­lion in its pock­et from Red­mile Group and over 10 oth­er in­vestors, Shat­tuck Labs has bagged Ab­hi­nav Shuk­la as chief tech­ni­cal of­fi­cer. Shuk­la joins the Austin, TX-based team from Red­pin Ther­a­peu­tics, hav­ing served as chief tech­ni­cal op­er­a­tions of­fi­cer. Pri­or to that, Shuk­la was with CRISPR Ther­a­peu­tics, Shire, Bris­tol My­ers, Am­gen and KBI Bio­phar­ma.

→  A cou­ple of months af­ter emerg­ing from stealth mode with a $100 mil­lion Se­ries B round and a mis­sion to out­smart can­cer re­sis­tance, The­seus Phar­ma­ceu­ti­cals has tapped Brad Dahms as its new CFO. The for­mer in­vest­ment banker is com­ing from Se­lec­ta Bio­sciences, where he re­cent­ly led a $730 mil­lion agree­ment to li­cense the com­pa­ny’s chron­ic re­frac­to­ry gout treat­ment to So­bi. Be­fore that, Dahms was a se­nior VP in the health­care group at Can­tor Fitzger­ald & Co., and held roles at RBC Cap­i­tal Mar­kets and JP Mor­gan. The­seus, backed by Or­biMed, says it will use the Se­ries B to ad­vance a suite of “pan-vari­ant” TKIs, in­clud­ing a lead com­pound tar­get­ing KIT-mu­tant gas­troin­testi­nal stro­mal tu­mors.

John Maslows­ki

→ Forge Bi­o­log­ics has reeled in John Maslows­ki in­to the new role of CCO. Maslows­ki jumps aboard from Cas­tle Creek Bio­sciences, where he was pres­i­dent and CEO. He served in the same role at Fi­bro­cell Sci­ence and had gigs at Wyeth, Mer­ck and Te­va. Maslows­ki was al­so the for­mer chair­man of the board of di­rec­tors at Fal­con Ther­a­peu­tics.

Ovid Ther­a­peu­tics is ex­pand­ing CBO’s Jef­frey Rona’s re­spon­si­bil­i­ties to in­clude the role of CFO. Rona joined the com­pa­ny in Oc­to­ber 2020. Pri­or to Ovid, Rona was head­ing op­er­a­tions at Dan­forth Ad­vi­sors as West­ern re­gion man­ag­ing di­rec­tor. Be­fore that, he was run­ning gigs as an ex­ec at GlobeIm­mune, Al­go­Rx Phar­ma­ceu­ti­cals and Great Basin Sci­en­tif­ic.

Jeff Rona

→ AI-based di­ag­nos­tic soft­ware in pathol­o­gy com­pa­ny Paige has ap­point­ed co-founder David Klim­stra as CMO. Klim­stra is cur­rent­ly the chair of the de­part­ment of pathol­o­gy at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter.

→  NEXGEL, a provider of hy­dro­gels for health­care and con­sumer ap­pli­ca­tions, has brought in Adam Drapczuk as CFO. Pri­or to his new role at NEXGEL, Drapczuk was fi­nan­cial con­troller for R-Pharm US. Drapczuk has al­so had stints at In­pel­lis, Tris Phar­ma and West-Ward Phar­ma­ceu­ti­cals.

→ Mer­ck KGaA has wel­comed a fresh slate of faces with the ap­point­ments of Amy Ma­h­ery as SVP, head of the neu­rol­o­gy and im­munol­o­gy glob­al busi­ness fran­chise; Jan Klatt as SVP, head of the de­vel­op­ment unit neu­rol­o­gy & im­munol­o­gy; and Amy Kao as head of trans­la­tion­al in­no­va­tion plat­form im­munol­o­gy.

Ma­h­ery pre­cious­ly served on the glob­al mar­ket ac­cess team at Mer­ck KGaA and serves as the health­care rep­re­sen­ta­tive on the Mer­ck di­ver­si­ty coun­cil. Mean­while, Klatt comes to the team from No­var­tis, where he most re­cent­ly served as glob­al pro­gram head, heart fail­ure. Fi­nal­ly, Kao comes aboard from Bio­gen, where she worked in ear­ly clin­i­cal de­vel­op­ment in im­munol­o­gy.

→ Irish drug de­vel­op­er Avadel Phar­ma­ceu­ti­cals — which saw its stock shoot up near­ly 33% on nar­colep­sy da­ta last April — has made a slew of new hires with the ap­point­ments of Jeff Cruik­shank as VP, sales; Denise Strauss as VP, mar­ket­ing and new prod­uct strat­e­gy and An­gela Woods as VP, peo­ple and cul­ture.

Denise Strauss

Cruik­shank comes to the com­pa­ny with ex­pe­ri­ence from Iron­wood Phar­ma­ceu­ti­cals, No­var­tis and Janssen Phar­ma­ceu­ti­cals un­der his belt. Mean­while, Strauss brings in her own ex­per­tise from her times at Gen­fit, Pfiz­er, Scher­ing-Plough and Boehringer In­gel­heim. Last but not least, Woods for­mer­ly served as VP, hu­man re­sources at Mallinck­rodt.

Athi­ra Phar­ma, go­ing af­ter one of phar­ma’s trick­i­est fields in Alzheimer’s dis­ease, has a new top lawyer. The Seat­tle-based biotech has tapped Mark Wor­thing­ton as their gen­er­al coun­sel, where he comes af­ter a 24-year stint at Sum­mit Law Group. Athi­ra went pub­lic in a $200 mil­lion-plus IPO in Sep­tem­ber 2020, and CEO Leen Kawas said in a state­ment that Wor­thing­ton will be in­volved in “busi­ness growth and strate­gic plans.”

Im­mu­nic — whose lead drug failed to im­press in 2 sep­a­rate tri­als — has ap­point­ed In­der­pal Singh as gen­er­al coun­sel. Singh joins the com­pa­ny from San­doz In­ter­na­tion­al GmbH, where he was glob­al le­gal head of bio­phar­ma. Pri­or to San­doz, Singh was with Mer­ck KGaA, Bio­gen Idec, Pfiz­er Deutsch­land GmbH and Pfiz­er.

→ Health­care in­vestor Gilde Health­care has snagged Joep Mui­jr­ers to the in­vest­ment team of its Ven­ture & Growth cap­i­tal fund. Mui­jr­ers will be re­spon­si­ble for Gilde’s in­vest­ments in pub­licly-trad­ed com­pa­nies fo­cused on ther­a­peu­tics, healthtech and med­ical de­vices in Eu­rope and the US. Mui­jr­ers for­mer­ly served as CFO and chief of port­fo­lio strat­e­gy at PureTech Health.

→ Med­ical de­vice Co Avisa Di­ag­nos­tics has added Bar­bara Bunger to its ex­ec­u­tive team in the new­ly cre­at­ed po­si­tion of VP, clin­i­cal de­vel­op­ment. Pri­or to her new role, Bunger served in roles at Clin­i­cal De­vel­op­ment and Reg­u­la­to­ry Ser­vicesBeck­ton Dick­in­son and Medtron­ic Spine & Bi­o­log­ics among oth­ers.

Mic­ki Klear­man

→ San Fran­cis­co’s Kezar Life Sci­ences — which bagged an $86.3 IPO back in 2018 — has en­list­ed Mic­ki Klear­man to its board of di­rec­tors. Klear­man brings to the board her ex­pe­ri­ence from her time at Genen­tech/Roche, where she served as group med­ical di­rec­tor in im­munol­o­gy.

→ Mel­bourne-based Opthea is bring­ing in Ju­lia Haller and Ju­dith Robert­son as in­de­pen­dent non-ex­ec­u­tive di­rec­tors to its board of di­rec­tors. Haller serves as pro­fes­sor and chair of the de­part­ment of oph­thal­mol­o­gy at Sid­ney Kim­mel Med­ical Col­lege at Thomas Jef­fer­son Uni­ver­si­ty. She al­so sits on the board of Bris­tol My­ers and is pres­i­dent of the John Hop­kins Med­ical and Sur­gi­cal As­so­ci­a­tion. Mean­while, Robert­son most re­cent­ly served as CCO of Eleu­sis and was the for­mer CCO of Aerie Phar­ma­ceu­ti­cals. Be­fore Arie, Robert­son was serv­ing at J&J, Janssen, BMS and No­var­tis.

Liz Cer­mak

Neu­rana Phar­ma­ceu­ti­cals — fo­cused on the treat­ment of neu­ro­mus­cu­lar con­di­tions — has brought in Geor­gia Er­bez and J&J vet Eliz­a­beth (Liz) Cer­mak to its board of di­rec­tors. Er­bez is the cur­rent CFO of Har­poon Ther­a­peu­tics and for­mer­ly head­ed lead­er­ship roles at Zosana Phar­ma, As­te­r­ias Bio­ther­a­peu­tics and Rap­tor Phar­ma­ceu­ti­cals. On the oth­er hand, Cer­mak cur­rent­ly sits on the boards of Mol­e­culin Biotech, Que On­col­o­gy and Clarus Ther­a­peu­tics. Cer­mak’s pre­vi­ous ex­pe­ri­ence in­cludes roles at SteadyMed Ther­a­peu­tics and POZEN.

Ab­b­Vie-part­nered I-Mab has tapped two ex­perts in Chi­na’s reg­u­la­to­ry land­scape to its board of di­rec­tors. Ruyi He, now CSO at Re­meGen, used to be the chief sci­en­tist at the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion’s Cen­ter for Drug Eval­u­a­tion, while Rong Shao is a pro­fes­sor drug ad­min­is­tra­tion poli­cies and reg­u­la­tions, Chi­na Phar­ma­ceu­ti­cal Uni­ver­si­ty.

Ruyi He

→ Men­lo Park, CA-based 180 Life Sci­ences has wel­comed Rus­sell Ray and Tere­sa DeLu­ca to its board of di­rec­tors. This is Ray’s sec­ond board seat, he al­so sits on the board of Mer­ri­mack Phar­ma­ceu­ti­cals. Ray for­mer­ly served as man­ag­ing di­rec­tor and co-head of glob­al health care at Cred­it Su­isse First Boston Cor­po­ra­tion. Mean­while, DeLu­ca comes aboard with ex­pe­ri­ence from GSK, Med­co, Wal­greens, Hu­mana and Mag­el­lan.

Bio­com Cal­i­for­nia, the as­so­ci­a­tion rep­re­sent­ing the Cal­i­for­nia life sci­ence in­dus­try, has re­cruit­ed Juli Moran to its board of gov­er­nors and Paul Mo­la to its board of di­rec­tors. Moran is man­ag­ing part­ner and man­ag­ing di­rec­tor of De­loitte Con­sult­ing, while Mo­la is pres­i­dent, CEO and founder of Roswell Biotech­nolo­gies.

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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