As Covid pro­gram ad­vances, Enan­ta's new CMO says it's not 'lim­it­ed to an­tivi­ral­s'; With all eyes on Gilead-part­nered can­cer drugs, Ar­cus brings med­ical chief on board

Ex­pect some pipeline ad­just­ments at Enan­ta Phar­ma­ceu­ti­cals in the com­ing years, be­cause new CMO Scott Rot­ting­haus thinks the an­tivi­ral biotech can ex­pand its hori­zons while al­so fig­ur­ing out a way to ad­dress the years­long Covid pan­dem­ic with an ex­pect­ed Phase II launch lat­er this year.

“I would like to take a look at what we have as pos­si­bil­i­ties com­ing out of the lab. We have such a strong dis­cov­ery pro­gram,” Rot­ting­haus told End­points News. “I don’t think we need to be lim­it­ed to an­tivi­rals here at Enan­ta; we can take a broad­er look at some oth­er ther­a­peu­tic ar­eas.”

Scott Rot­ting­haus

For now, though, the for­mer hema­tol­ogy and nephrol­o­gy clin­i­cal de­vel­op­ment leader at Alex­ion, which last year was swooped up by As­traZeneca, is re­turn­ing to his roots in the in­fec­tious dis­ease field.

In un­der­grad at Kansas State, poly­omavirus struc­tur­al pro­teins con­sumed Rot­ting­haus’ at­ten­tion. Then it was vac­cine work on measles and in­fluen­za dur­ing med­ical school and res­i­den­cy at Mayo Clin­ic. A stint work­ing on HSV came next, as an in­fec­tious dis­ease fel­low at the Uni­ver­si­ty of Al­aba­ma at Birm­ing­ham in the mid-aughts. An­timi­cro­bials and vac­cines took cen­ter stage dur­ing an eight-year post at Pfiz­er, in­clud­ing a clin­i­cal lead role on bac­te­r­i­al in­fec­tion med Ty­gacil.

“Big Phar­ma in the past decade has lost some in­ter­est in an­ti-in­fec­tives, which is what caused me to kind of move away as op­por­tu­ni­ties knocked. When I heard about the op­por­tu­ni­ty at Enan­ta, it was ac­tu­al­ly a fair­ly easy choice for me,” the CMO said.

In his telling, Rot­ting­haus is “very ex­cit­ed” or “re­al­ly ex­cit­ed” about the work ahead, mak­ing it clear four times in the first minute of an in­ter­view on day three in the new C-suite post.

Covid-19 and res­pi­ra­to­ry syn­cy­tial virus are “right at the top of the list,” he said. Fol­low­ing Phase I da­ta on its once-dai­ly oral drug late last month, Enan­ta will meet with the FDA “in the very near fu­ture” to agree on a Phase II pro­gram for EDP-235, a 3CL pro­tease in­hibitor. That tri­al is slat­ed to be glob­al in scope to “move it for­ward as quick­ly as pos­si­ble,” the new CMO said. Enan­ta is al­so in the midst of su­ing Rot­ting­haus’ for­mer em­ploy­er, Pfiz­er, over the Big Phar­ma’s Covid drug, Paxlovid.

Be­yond Covid, Rot­ting­haus will dig in­to a Phase IIb test­ing EDP-938 in adults at high risk for get­ting in­fect­ed with RSV. In May, the drug flunked a mid-stage test in oth­er­wise healthy adults with com­mu­ni­ty-ac­quired RSV.

Kyle LaHu­cik

Dim­it­ry Nuyten

→ Things look a lit­tle hazier for Ar­cus Bio­sciences and Gilead’s CD73 can­di­date quem­li­clu­s­tat af­ter an­a­lysts voice their disp­point­ment with the lat­est up­date on a drug that “ex­ceed­ed ex­pec­ta­tions” at AACR in ear­ly 2021. Dim­it­ry Nuyten has now tak­en com­mand of Ar­cus’ clin­i­cal de­vel­op­ment as CMO and pre­sides over a pipeline that, along­side quem­li­clu­s­tat, in­cludes a clutch of can­cer drugs like dom­vanal­imab and etru­madenant at the heart of the $725 mil­lion deal with Gilead. The ex-med­ical chief at Nek­tar and Aduro Biotech, Nuyten has al­so been VP of glob­al prod­uct de­vel­op­ment for on­col­o­gy at Pfiz­er and a group med­ical di­rec­tor for Bris­tol My­ers Squibb.

Math­ai Mam­men

→ The big names in J&J’s lead­er­ship struc­ture are grad­u­al­ly peel­ing away as head of R&D Math­ai Mam­men packs his bags to “pur­sue oth­er op­por­tu­ni­ties out­side of the Com­pa­ny,” ac­cord­ing to a state­ment that pro­vid­ed few de­tails be­yond his in­ter­im suc­ces­sor, chief in­no­va­tion of­fi­cer William Hait. Mam­men’s sud­den de­par­ture late Mon­day fol­lows that of ex-CSO Paul Stof­fels, who’s now reshuf­fling the deck at Gala­pa­gos as CEO, and it comes near­ly a year af­ter J&J first an­nounced that Joaquin Du­a­to would re­place now-ex­ec­u­tive chair­man Alex Gorsky as CEO.

Win­selow Tuck­er

Eli Lil­ly’s Stephen Fry will re­tire at the end of the year as Loxo com­mer­cial chief Er­ic Dozi­er is set to re­place him as SVP, hu­man re­sources and di­ver­si­ty. Fry start­ed as a sys­tems an­a­lyst at the In­di­anapo­lis phar­ma in 1987 and has held his cur­rent role since 2011, while Dozi­er is al­so a long­time Lil­ly vet who’s held such roles as gen­er­al man­ag­er, Puer­to Ri­co and chief mar­ket­ing of­fi­cer for Japan. At the end of this month, Win­selow Tuck­er will leave Bris­tol My­ers and suc­ceed Dozi­er as Loxo’s chief com­mer­cial of­fi­cer. Tuck­er joined BMS from No­var­tis in 2019 as SVP and gen­er­al man­ag­er, US hema­tol­ogy and was el­e­vat­ed to SVP, in­ter­con­ti­nen­tal in Jan­u­ary.

Sim­ba Gill

Sim­ba Gill will on­ly be CEO of Evelo Bio­sciences a lit­tle while longer, be­com­ing chair­man of Evelo’s board and head­ing back to Flag­ship Pi­o­neer­ing “to help launch, grow, and guide bio­plat­form com­pa­nies” as an ex­ec­u­tive part­ner. Both ap­point­ments will take ef­fect when a suc­ces­sor is named. As found­ing chief ex­ec­u­tive, Gill shep­herd­ed Evelo to an IPO in 2018 and in­to Phase II tri­als with its lead pro­gram in pso­ri­a­sis and atopic der­mati­tis. With the bear mar­ket hit­ting the sec­tor hard, Evelo cush­ioned the blow with a $79.2 mil­lion di­rect of­fer­ing in late May.

Howard Davis

→ Bris­tol My­ers part­ner PsiOxus Ther­a­peu­tics, an Ox­ford, UK-based can­cer biotech once backed by Neil Wood­ford, has lined up Howard Davis as CEO. Davis jumps to the top spot here af­ter help­ing launch Third Har­mon­ic Bio as COO; the No­var­tis and Bio­gen alum has al­so been a prin­ci­pal at Flag­ship. Priya Mande, the in­ter­im chief for the last year, will be­come PsiOxus’ COO and UK pres­i­dent.

Chris Franken­field

Xilio Ther­a­peu­tics propped open a win­dow in­to some ear­ly da­ta with XTX101 for sol­id tu­mors, and in the same re­lease, the biotech shared the pro­mo­tions of Uli Bialucha to CSO and Chris Franken­field to chief le­gal and ad­min­is­tra­tive of­fi­cer. Both ex­ecs ar­rived last year, with Bialucha orig­i­nal­ly join­ing Xilio from Im­mu­ni­tas Ther­a­peu­tics as SVP of re­search and Franken­field com­ing from Blue­print Med­i­cines to take on the role of gen­er­al coun­sel.

Tim­o­thy Hunt

Tim­o­thy Hunt will take over as CEO of The Al­liance for Re­gen­er­a­tive Med­i­cine on Sept. 6, re­plac­ing Janet Lynch Lam­bert. Once part of ARM’s Gene Edit­ing Task Force, Hunt had just tak­en on the role of chief cul­ture and cor­po­rate af­fairs of­fi­cer at Xilio in Oc­to­ber 2021. He was al­so chief cor­po­rate af­fairs of­fi­cer at Ed­i­tas Med­i­cine from 2016-20 and a pub­lic af­fairs ex­ec with Bio­gen.

Mike No­haile

→ Con­cur­rent with its $35 mil­lion Se­ries C haul, San Fran­cis­co’s Prel­lis Bi­o­log­ics has wel­comed Mike No­haile as CEO. No­haile leaves his CSO post at Flag­ship’s Gen­er­ate Bio­med­i­cines and his Big Phar­ma back­ground con­sists of mul­ti­ple roles over a 14-year pe­ri­od at No­var­tis (in­clud­ing four years as glob­al head of mol­e­c­u­lar di­ag­nos­tics) and Am­gen (round­ing out his tenure as SVP of strat­e­gy, com­mer­cial­iza­tion, and in­no­va­tion). Prel­lis teamed up with Bris­tol My­ers and Sanofi in sep­a­rate an­ti­body deals ear­li­er this year.

→ Ground­ed by the FDA with a clin­i­cal hold on its CAR-T drug BEAM-201 for re­lapsed/re­frac­to­ry T-cell acute lym­phoblas­tic leukemia and lym­phoma, Beam Ther­a­peu­tics has in­stalled John Lo as chief com­mer­cial of­fi­cer. Big Phar­ma con­nec­tions abound with Lo, who led the hema­tol­ogy fran­chise dur­ing his eight years at No­var­tis; worked on such drugs as Tagris­so and Imfinzi at As­traZeneca and was the phar­ma gi­ant’s head of glob­al mar­ket­ing and mar­ket ac­cess; and be­came SVP of world­wide hema­tol­ogy for Bris­tol My­ers in 2019 af­ter the Cel­gene buy­out.

Ja­son Dami­ano

The Ap­pi­an Way: Los An­ge­les-based Ap­pia Biode­vel­op­ing off-the-shelf CAR ther­a­pies with in­vari­ant nat­ur­al killer T cells (iNKT) and team­ing up with Kite in a deal worth up to $875 mil­lion — has rolled out the wel­come mat for Ja­son Dami­ano as CSO. Dami­ano wraps up a three-year run at Uni­ty Biotech­nol­o­gy as VP of bi­ol­o­gy, and from 2016-18 he was di­rec­tor of ther­a­peu­tic an­ti­body dis­cov­ery and trans­la­tion­al med­i­cine at Achao­gen. Ex-Kite and Lyell CSO Mar­go Roberts has sewn up a spot on the board of di­rec­tors at Ap­pia Bio, a com­pa­ny chaired by No­bel lau­re­ate David Bal­ti­more and led by for­mer Tenaya pres­i­dent JJ Kang.

Dou­glas Warn­er

→ Look­ing to re­group with its tomivosert­ib/Keytru­da com­bo in NSCLC while swift­ly slid­ing $EFTR in­to a pen­ny stock morass, eF­FEC­TOR Ther­a­peu­tics has tapped Dou­glas Warn­er as CMO. Warn­er breaks away from Am­gen af­ter an 18-year run that end­ed as ex­ec­u­tive med­ical di­rec­tor, group prod­uct area lead. Along with tomivosert­ib, he takes charge of eF­FEC­TOR’s ear­ly-stage stud­ies of zo­tat­ifin in sol­id tu­mors and Covid-19.

Ken­neth Tru­itt

Ken­neth Tru­itt has signed on as CMO of Aque­s­tive Ther­a­peu­tics, which changed CEOs three months ago as it tries to get in the good graces of the FDA with the seizure drug Liber­vant and its ep­i­neph­rine oral film AQST-109. Tru­itt, whose first day at Aque­s­tive is Sept. 6, spent 16 years at Dai­ichi Sankyo be­fore his ap­point­ments as med­ical chief of Im­mu­sanT in 2018 and Ven­thera a year lat­er. Mean­while, Hu­mani­gen COO and CFO Tim Mor­ris has joined Aque­s­tive’s board of di­rec­tors.

Car­o­line Ger­ma

→ Big Phar­ma vet Car­o­line Ger­ma has been named EVP, glob­al med­i­cine de­vel­op­ment and CMO at Chi­nese an­ti­body biotech Tran­scen­ta. Ger­ma’s CV reads like a who’s who of the in­dus­try: Af­ter six years at Eli Lil­ly, she was clin­i­cal lead for breast can­cer med ner­a­tinib (Ner­l­ynx) dur­ing her four years at Pfiz­er. She then jumped to No­var­tis in 2011, where she rose to se­nior glob­al pro­gram clin­i­cal head for ri­bo­ci­clib (Kisqali) and canakinum­ab. She then left for Bris­tol My­ers in 2018, stay­ing there for a year be­fore join­ing As­traZeneca as VP and head of the ear­ly de­vel­op­ment clin­i­cal group for on­col­o­gy.

PJ Ramtin

PJ Ramtin has set­tled in as SVP of busi­ness op­er­a­tions at Spruce Bio­sciences, which is de­vel­op­ing tildac­er­font for en­docrine dis­or­ders such as clas­sic con­gen­i­tal adren­al hy­per­pla­sia. Ramtin joined Spruce in June af­ter three years with Bridge­Bio as VP, com­mer­cial op­er­a­tions and VP, busi­ness op­er­a­tions. Ear­li­er, she was on­col­o­gy busi­ness di­rec­tor at Re­gen­eron and had two sep­a­rate stints at Genen­tech.

Vikram Lam­ba

→ Cal­i­for­nia CAR-T play­er Imm­PACT Bio has had it­self a year with $111 mil­lion in Se­ries B fund­ing, the ad­di­tion of board chair Sheila Gu­jrathi and a grow­ing C-suite that now in­cludes ex-Zosano Phar­ma chief Vikram Lam­ba as CFO and head of busi­ness de­vel­op­ment. The Bay­er vet had been CFO of di­ag­nos­tics com­pa­ny Chro­ma­Code since April 2021. Imm­PACT Bio has al­so ap­point­ed a chief tech­nol­o­gy of­fi­cer (Syl­vain Roy) and COO (Venkat Yepuri) in the last few months.

Joy Zhou

→ Tucked in­to its Q2 re­port, nat­ur­al killer biotech MiNK Ther­a­peu­tics men­tioned that Joy Zhou has been ap­point­ed head of CMC. Zhou is the for­mer head of drug prod­uct de­vel­op­ment, cell ther­a­py at Take­da who re­cent­ly led MS&T (man­u­fac­tur­ing sci­ences & tech­nol­o­gy) at Ru­bius Ther­a­peu­tics; ear­ly in her ca­reer, she was a sci­en­tist at Pfiz­er and J&J. Just be­fore the bot­tom fell out of the sec­tor, MiNK went pub­lic in Oc­to­ber 2021 with a $40 mil­lion IPO.

Nicholas Pachu­da

Pe­ter Thiel-backed pep­tide drug de­sign biotech Pep­ti­log­ics has en­list­ed At­ul Desh­pande as chief strat­e­gy of­fi­cer and pro­mot­ed Nicholas Pachu­da to COO. Desh­pande joins the Pitts­burgh-based com­pa­ny from Im­me­di­ate Ther­a­peu­tics, where he served at the helm of the com­pa­ny as CEO. Pri­or to that stint, Desh­pande was chief strat­e­gy of­fi­cer and head of US op­er­a­tions for Har­bour Bio­Med and glob­al op­er­a­tions head for the Dupix­ent fran­chise at Sanofi.

Pachu­da joined Pep­ti­log­ics in 2020, start­ing as SVP of port­fo­lio and de­vel­op­ment. Pachu­da hopped aboard Pep­ti­log­ics af­ter a gig at J&J, lead­ing ex­ter­nal in­no­va­tion for the com­pa­ny’s or­tho­pe­dic de­vice fran­chise.

Sabine Sydow

→ Ger­man CD­MO Rentschler Bio­phar­ma, which was slapped with a Form 483 for mul­ti­ple pro­duc­tion is­sues in June, has brought aboard Sabine Sydow as chief of staff and Falk Nuern­berg­er as cor­po­rate gen­er­al coun­sel. Sydow was for­mer­ly the head of vfa bio, where she had a 16-year run. Mean­while, Nuern­berg­er served as gen­er­al coun­sel Eu­rope of Vi­a­tris and has had stints at Medi­Gene, San­doz and Ac­tavis.

→ Ear­ly can­cer screen­ing and de­tec­tion-fo­cused biotech An­Pac Bio-Med­ical Sci­ence has ush­ered in Yuyang Cui as co-chair­man of the board and co-CEO of the com­pa­ny and Ji­awen Kang as a mem­ber of its board of di­rec­tors. Cui and Kang’s ap­point­ments come as An­Pac has re-shuf­fled some of its board and ex­ec team. An­Pac re­lieved Aidong Chen from his du­ties as co-chair­man and co-CEO and re­moved Sheng Liu from its board. In ad­di­tion, the com­pa­ny has re-des­ig­nat­ed Chris Chang Yu as co-CEO and chair­man of the board.

Joseph Dama­sio

→ Bio­engi­neer­ing com­pa­ny Biostage has pulled in Joseph Dama­sio as CFO. Dama­sio for­mer­ly served as VP, fi­nance at In­hibikase Ther­a­peu­tics, con­troller at Cue Bio­phar­ma and CFO of Pres­sure Bio­Sciences.

→ With the small­pox an­tivi­ral Tem­bexa (brin­cid­o­fovir) await­ing a con­tract sig­na­ture from BAR­DA and talks of po­ten­tial use in the mon­key­pox out­break — af­ter the com­pas­sion­ate-use hub­bub in 2014 that in­volved young Josh Hardy re­ceiv­ing the drug — Chimerix has pegged Christo­pher Jor­dan as VP, reg­u­la­to­ry af­fairs. Jor­dan, an Eli Lil­ly alum, held the role of se­nior glob­al pro­gram reg­u­la­to­ry di­rec­tor at No­var­tis af­ter a string of reg­u­la­to­ry posts at En­do­cyte from 2013-19.

→ Hous­ton-based TCR-T out­fit Alaunos Ther­a­peu­tics, once known as Boston-based Zio­pharm On­col­o­gy, is bring­ing in Ab­hishek Sri­vas­ta­va as VP, tech­ni­cal op­er­a­tions. A for­mer as­sis­tant pro­fes­sor at the Uni­ver­si­ty of Pitts­burgh School of Med­i­cine, Sri­vas­ta­va comes to Alaunos from Athenex, where he was VP, cell ther­a­py de­vel­op­ment.

Mary Mc­Na­ma­ra-Cul­li­nane

Clear­Point Neu­ro has re­cruit­ed Mary Mc­Na­ma­ra-Cul­li­nane as VP of reg­u­la­to­ry af­fairs. Mc­Na­ma­ra-Cul­li­nane joins from Ali­ra Health, where she was SVP of reg­u­la­to­ry af­fairs. Pri­or to that, Mc­Na­ma­ra-Cul­li­nane was prin­ci­pal of MMC reg­u­la­to­ry con­sult­ing at In­trin­sic Ther­a­peu­tics and Echo Ther­a­peu­tics.

Kem­Pharm, which forked over $12.8 mil­lion in cash for Or­p­hazyme and its “pipeline-in-a-prod­uct” in May, has se­lect­ed Nichol Ochsner as VP, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Ochsner was pre­vi­ous­ly an in­vestor re­la­tions and com­mu­ni­ca­tions ex­ec with Stat­era Bio­phar­ma and Ther­a­peu­tic­sMD.

John Maraganore

→ Just when you think the Maraganore Me­ter is tak­ing a breather at Peer Re­view, here he comes again: For­mer Al­ny­lam CEO John Maraganore is mak­ing his way to the board of di­rec­tors at ProKid­ney with Nu­va­tion Bio CFO Jen­nifer Fox. The list of board ap­point­ments and ad­vi­so­ry roles for Maraganore is as long as your arm, from chair­ing the board at Hemab Ther­a­peu­tics to help­ing out Over­land Phar­ma­ceu­ti­cals as a strate­gic ad­vi­sor — and be­yond.

→ For­mer HHS Sec­re­tary Alex Azar has popped up over at 3D Sys­tems as part of the com­pa­ny’s med­ical ad­vi­so­ry board. Azar brings with him a wealth of ex­pe­ri­ence in­clud­ing his time as pres­i­dent of the US di­vi­sion of Eli Lil­ly and as a board mem­ber of BIO. Lead­ing up to his role as HHS sec­re­tary un­der for­mer pres­i­dent Don­ald Trump, Azar for­mer­ly served as gen­er­al coun­sel of HHS start­ing in 2001.

Thomas Soloway

Na­tal­ie Holles-led Third Har­mon­ic Bio is shoring up its board of di­rec­tors by ap­point­ing Thomas Soloway. The cur­rent T-knife CEO was Holles’ COO at Au­dentes and he’s al­so on the board at Sat­suma Phar­ma­ceu­ti­cals.

→ Liv­er dis­ease biotech Al­bireo has elect­ed Habib Dable and Su­san Alesina to the board of di­rec­tors. Dable was pres­i­dent and CEO of Ac­celeron af­ter a 22-year ca­reer with Bay­er, while Alesina is a Mil­li­pore­Sig­ma and Sunovion vet who is VP, na­tion­al busi­ness de­vel­op­ment and al­liances at Boston Chil­dren’s Hos­pi­tal.

MindMed, the com­pa­ny fo­cused on brain health dis­or­ders, has signed on Suzanne Bruhn and Roger Crys­tal to its board of di­rec­tors. Bruhn is pres­i­dent, CEO and di­rec­tor of Tia­ki Ther­a­peu­tics while Crys­tal is the pres­i­dent, CEO and di­rec­tor of Opi­ant Phar­ma­ceu­ti­cals and the lead in­ven­tor of the Nar­can nasal spray.

→ Carls­bad, CA-based Cu­rate Bio­sciences has tapped Daniel Getts as a new mem­ber of its board of di­rec­tors. Getts is the co-founder and CEO of Myeloid Ther­a­peu­tics and has pre­vi­ous­ly had gigs as VP of re­search at TCR2 Ther­a­peu­tics and co-founder and CSO of Cour Phar­ma­ceu­ti­cals.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Ex­clu­sive: Cell ther­a­py biotech brings on Loxo vet amid glob­al ex­pan­sion plans; Re­tire­ment beck­ons for Vir's George Scan­gos

Bree Harlin, who used to be director of clinical operations at Loxo Oncology, now Loxo@Lilly, is now in the C-suite for the first time.

Harlin started at TC BioPharm on Wednesday as chief clinical officer, the biotech announced Friday — but her journey starts more than 20 years before then. After graduating from college, she moved to Boston, working in academia at some of the Harvard teaching hospitals in endocrinology and CNS.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.