Robert Baze­more makes Hutchmed deal his grand fi­nale as Epizyme CEO; Black Di­a­mond reshuf­fles the deck with de­par­tures of CMO, CSO

Robert Baze­more

→ One minute, Epizyme CEO Robert Baze­more helped en­gi­neer a part­ner­ship with Hutchmed on de­vel­op­ing Tazverik in Chi­na. The next minute, he gave his job to some­one else.

Baze­more stepped aside as Epizyme’s chief ex­ec­u­tive the same day the biotech an­nounced the deal, ced­ing the throne to Grant Bogle, the chief com­mer­cial of­fi­cer at Tesaro from 2015 un­til 2019 — the year Glax­o­SmithK­line’s takeover of the on­col­o­gy-fo­cused com­pa­ny was com­plet­ed. Since 2019, Bogle has kept a seat on Epizyme’s board of di­rec­tors.

Baze­more will lend ad­vi­so­ry sup­port for an­oth­er year. “I feel the time is right to hand the reins over to Grant and I am ex­cit­ed to work close­ly with him to achieve Epizyme’s vi­sion,” Baze­more said in a state­ment.

Eliz­a­beth Buck

→ Ac­cord­ing to an SEC fil­ing and Black Di­a­mond’s Q2 up­date, CMO Rachel Humphrey and CSO Christo­pher Roberts are out at the pre­ci­sion on­col­o­gy out­fit led by David Ep­stein. Karsten Witt, the act­ing CMO un­til Humphrey took over less than a year ago, has as­sumed the role again on an in­ter­im ba­sis up­on Humphrey’s “ter­mi­na­tion,” to use the lan­guage in the fil­ing, while Black Di­a­mond co-founder Eliz­a­beth Buck of­fi­cial­ly stepped in as chief sci­en­tist on Wednes­day af­ter Roberts re­signed Ju­ly 12. Ad­di­tion­al­ly, Black Di­a­mond has made ex-G1 Ther­a­peu­tics CEO Mark Vel­le­ca a mem­ber of the board of di­rec­tors that is chaired by for­mer GSK (then Glax­oW­ell­come) CEO Bob In­gram.

Julie Krop

PureTech, the com­pa­ny work­ing to turn a 200-year-old dis­cov­ery in­to a new ap­proach to Alzheimer’s, has plucked up Julie Krop as CMO. Krop jumps aboard from her most re­cent stint as CMO of Free­line Ther­a­peu­tics. Pri­or to her time at Free­line, Krop was han­dling af­fairs as CMO at AM­AG Phar­ma­ceu­ti­cals, where she over­saw three FDA ap­provals for the com­pa­ny. In ad­di­tion to those stints, Krop brings to the ta­ble a hefty amount of ex­pe­ri­ence from her time at Ver­tex Phar­ma­ceu­ti­cals, Stryk­er Re­gen­er­a­tive Med­i­cine, Pep­ti­m­mune, Mil­len­ni­um Phar­ma­ceu­ti­cals and Pfiz­er.

Kr­ish­nan Viswanad­han

CEO Joanne Smith-Far­rell is piec­ing to­geth­er her team at Be Bio, swing­ing the door open for new pres­i­dent and COO Kr­ish­nan Viswanad­han and chief peo­ple of­fi­cer Brad Hart­man at the B cell-cen­tered biotech. A Roche vet in reg­u­la­to­ry af­fairs, Viswanad­han was most re­cent­ly SVP and glob­al cell ther­a­py fran­chise lead at Bris­tol My­ers Squibb and held lead­er­ship po­si­tions at Cel­gene pri­or to that ap­point­ment. Hart­man is the for­mer chief peo­ple of­fi­cer at Fer­Gene who was al­so the VP of peo­ple at reSTOR­bio, Pro­teon Ther­a­peu­tics and Unum (now Co­gent Bio­sciences).

Kara Bick­ham

→ The C-suite at Affini­vax grows once again af­ter the ap­point­ments of CBO Stu­art Chaf­fee in April and CFO Eliz­a­beth Rad­cliffe in May, as Kara Bick­ham breaks away from Big Phar­ma pneu­mo­coc­cal vac­cine ri­val Mer­ck to be­come CMO. Bick­ham led the clin­i­cal de­vel­op­ment of Mer­ck’s 15-va­lent pneu­mo­coc­cal vac­cine shot Vaxneu­vance, which the FDA ap­proved last month and cov­ers the same strains as Pfiz­er’s Pre­vnar 13 along with two oth­ers. Can Affini­vax catch up with these for­mi­da­ble foes? They have $226 mil­lion worth of Se­ries C cash to cer­tain­ly try.

Niru­pa­ma Sub­ra­man­ian

Niru­pa­ma Sub­ra­man­ian has been named COO of Third Rock start­up Rheos Med­i­cines, which struck a deal with Roche in De­cem­ber 2019 to de­vel­op drugs with­in the im­munome­tab­o­lism field. Sub­ra­man­ian had been a part of the Agios team since 2016, and since Jan­u­ary 2020 was Jack­ie Fouse’s SVP, cor­po­rate de­vel­op­ment & busi­ness plan­ning. Her eight pre­ced­ing years at No­var­tis reached its con­clu­sion as VP, vac­cines busi­ness tran­si­tion lead, when No­var­tis Vac­cines was sold to GSK in 2014 for $7.1 bil­lion.

→ San Fran­cis­co’s Al­tru­Bio has locked in Jeroen Gras­man as CFO to push its drugs for im­muno­log­i­cal dis­eases in­to the mar­ket af­ter net­ting $63 mil­lion in a Se­ries A three months ago. Gras­man hails from neoanti­gen biotech PACT Phar­ma, where he was VP of fi­nance and op­er­a­tions, and he’s al­so held fi­nan­cial roles at Roche and Genen­tech. Led by sec­ond-year CEO Judy Chou, Al­tru­Bio changed its name from AbGe­nomics in June 2020 and the FDA pro­vid­ed ex­tra mo­men­tum with a fast track des­ig­na­tion for its lead drug nei­hulizum­ab in steroid re­frac­to­ry acute graft-ver­sus-host dis­ease (SR-aGVHD).

Neil Ab­dol­lahi­an

→ Sit­ting pret­ty with a $110 mil­lion Se­ries B raise from April to study the role of ex­tra­chro­mo­so­mal DNA (ecD­NA) in a slew of can­cers, San Diego-based Bound­less Bio has se­lect­ed Neil Ab­dol­lahi­an as CBO. When Ab­dol­lahi­an held the same po­si­tion at Cidara Ther­a­peu­tics the last five years, he was a key cog in the $780 mil­lion deal Janssen made for the biotech’s lead an­tivi­ral con­ju­gate CD388 that can be ca­pa­ble of stand­ing up to any flu strain, as CEO Jeff Stein told End­points News.

→ Fol­low­ing Michael Amoroso’s rapid as­cent to CEO ear­li­er this year, Abeona ush­ered in re­search & clin­i­cal de­vel­op­ment head Vish­was Se­shadri on June 1 and this week has pro­mot­ed Ed­ward Carr to CFO. Carr first pulled up to Abeona in 2018 as cor­po­rate con­troller, and then he was quick­ly el­e­vat­ed to chief ac­count­ing of­fi­cer in Jan­u­ary 2019. Ex-Abeona CFO Chris­tine Sil­ver­stein has since be­come the CFO of Ex­ci­sion Bio­Ther­a­peu­tics.

Bet­zy Estra­da

Bet­zy Estra­da has got­ten the call to be EVP and chief hu­man re­sources of­fi­cer at Urovant, the Sum­i­to­vant sub hatched by Vivek Ra­maswamy that won an FDA ap­proval for its over­ac­tive blad­der drug vibegron at the tail end of 2020. Estra­da, a for­mer HR man­ag­er at Ad­vanced Ster­il­iza­tion Prod­ucts be­fore J&J sold it in 2018, spent the last six years as VP, hu­man re­sources, and chief com­pli­ance ex­ec­u­tive at Japan­ese med­ical elec­tron­ic equip­ment man­u­fac­tur­er Ni­hon Ko­hden.

→ Hit­ting Nas­daq ear­ly in 2021 with an IPO that closed at $161 mil­lion, WuXi-backed on­col­o­gy biotech Ada­gene has tapped Steven Fis­chkoff as in­ter­im CMO. This isn’t Fis­chkoff’s first time step­ping on the CMO court with pre­vi­ous stops at Li­on Biotech­nolo­gies, Wind­MIL Ther­a­peu­tics and Flame Bio­sciences, and he’s been VP of clin­i­cal and med­ical af­fairs at Cel­gene. Ada­gene, col­lab­o­rat­ing on a CAR-T can­di­date with the NIH in re­nal cell car­ci­no­ma, has al­so ap­point­ed Stan­ley Frankel and Robert Spiegel to the sci­en­tif­ic and strate­gic ad­vi­so­ry board.

Daniela Dra­go

→ If there’s any­one who could have the in­side scoop on just how in the world Aduhelm notched its ac­cel­er­at­ed ap­proval for Alzheimer’s, it’s prob­a­bly Daniela Dra­go, who leaves Bio­gen and has been ap­point­ed chief reg­u­la­to­ry of­fi­cer at Au­ri­on Biotech. Dra­go had been se­nior di­rec­tor of reg­u­la­to­ry at Bio­gen since 2019 and her reg­u­la­to­ry back­ground al­so ex­tends to Bausch + Lomb, Roche and Vi­for Phar­ma. Eye dis­ease-fo­cused Au­ri­on Biotech is specif­i­cal­ly de­vel­op­ing a cell ther­a­py for corneal ede­ma.

Eli Lil­ly and Genen­tech alum Jef­frey Bloss is tak­ing on the role of CMO at UK-based can­cer play­er Nu­Cana. Pri­or to con­sec­u­tive CMO gigs at Tarve­da Ther­a­peu­tics and Aege­ri­on, Bloss was SVP, med­ical af­fairs for the Amer­i­c­as for Astel­las Sci­en­tif­ic and Med­ical Af­fairs (AS­MA) and GSK’s VP and head of on­col­o­gy glob­al med­ical af­fairs.

Jane Chung

Sutro Bio­phar­ma jumps back in­to Peer Re­view by bring­ing in Jane Chung, the drug dis­cov­ery play­er’s first chief com­mer­cial of­fi­cer. For­mer­ly the com­mer­cial op­er­a­tions man­ag­er for Avastin dur­ing a por­tion of her decade at Genen­tech, Chung had been pres­i­dent and gen­er­al man­ag­er of As­traZeneca Cana­da since No­vem­ber 2019 and joined the Big Phar­ma in 2015 af­ter two years at Onyx Phar­ma­ceu­ti­cals. We last saw Sutro back in April when Trevor Hal­lam was pro­mot­ed to pres­i­dent of re­search, CSO.

→ Nether­lands-based Im­mune­tune has ush­ered in Si­jme Zeile­mak­er as CEO. Zeile­mak­er makes his way to the com­pa­ny from Im­mu­nicum, where he served as COO, di­rec­tor busi­ness de­vel­op­ment and head of in­vestor re­la­tions. Be­fore join­ing Im­mu­nicum in 2017, Zeile­mak­er was di­rec­tor busi­ness de­vel­op­ment at In­teR­NA Tech­nolo­gies and held roles at to-BBB tech­nolo­gies and 2-BBB Med­i­cines.

Josh Munt­ner

Im­vax hit pay dirt with a Se­ries C to­tal­ing $112 mil­lion in Ju­ly 2020 to de­vel­op tu­mor-de­rived im­munother­a­pies like its glioblas­toma can­di­date IGV-2001, and Josh Munt­ner will be lead­ing the fi­nan­cial side of the com­pa­ny start­ing Aug. 31. Munt­ner takes this CFO job af­ter three years in the same post at star-crossed Mesoblast, and ear­li­er he was Con­tra­Fect’s SVP of busi­ness de­vel­op­ment.

Hol­ly Schachn­er

Rain­bow Seek­er: Hol­ly Schachn­er comes stream­ing in­to Dou­bleRain­bow Bio­sciences as its CMO. Schachn­er hops on board from MyoKar­dia, where she was SVP, ther­a­peu­tic head of clin­i­cal sci­ence. Pri­or to that role, Schachn­er was CMO spe­cial­ty med­i­cine at Al­ler­gan and held roles at Sanofi, Bay­er Di­a­betes Care and Pfiz­er.

AEON Bio­phar­ma has brought on Alex Wil­son as gen­er­al coun­sel. Wil­son comes aboard from Glaukos, where he served as as­so­ciate gen­er­al coun­sel, busi­ness de­vel­op­ment & sus­tain­abil­i­ty. Pri­or to that, Wil­son was a cor­po­rate at­tor­ney at O’Mel­ve­ny & My­ers.

Tony Fraij

AGC Bi­o­log­ics has hand­ed the ti­tle of gen­er­al man­ag­er of its new Long­mont plant — for­mer­ly owned by No­var­tis Gene Ther­a­pies — to Tony Fraij. Fraij pre­vi­ous­ly served as VP of tech­ni­cal op­er­a­tions for AveX­is. Be­fore his time with AveX­is, Fraij was work­ing in roles at Boehringer In­gel­heim and San­doz.

An­tios Ther­a­peu­tics has ap­point­ed Cather­ine Cof­fey Ross VP, med­ical af­fairs, wrap­ping up al­most 9 years at Ab­b­Vie as their for­mer di­rec­tor of glob­al busi­ness de­vel­op­ment. Her ar­rival at At­lanta-based An­tios is just two months af­ter the com­pa­ny an­nounced a part­ner­ship in June with Ar­bu­tus with ATI-2173, its can­di­date as a monother­a­py for HBV. Two months ear­li­er, new CEO Greg Mayes hint­ed that the com­pa­ny will be prepar­ing for an IPO as they closed a $96 mil­lion crossover round to see ATI-2173 en­ter Phase II clin­i­cal tri­als.

→ Join­ing the SPAC brigade in Feb­ru­ary by re­verse merg­ing with Arya Sci­ences Ac­qui­si­tion Corp III, Seat­tle-based Nau­tilus Biotech­nol­o­gy has picked up Karl Voss as VP of life sci­ences R&D. Voss com­pletes a 13-year run at Pa­cif­ic Bio­sciences that saw him get pro­mot­ed to VP, con­sum­ables R&D and then head of ma­te­ri­als and sur­face sci­ence. Count Jeff Be­zos, An­dreessen Horowitz and the late Paul Allen’s Vul­can Cap­i­tal among those that have helped fund Nau­tilus, co-found­ed five years ago by Su­jal Pa­tel and Parag Mallick.

Mar­i­on Sny­der

→ Pfiz­er alum Mar­i­on Sny­der has been pro­mot­ed to chief of staff, SVP, gov­ern­ment af­fairs at MiMedx af­ter two years as SVP, mar­ket ac­cess. Sny­der, who worked in ac­count man­age­ment when she start­ed at MiMedx in 2013, had a 13-year run at Pfiz­er in such roles as di­rec­tor of pay­er mar­ket­ing for En­brel.

IAVI has made a cou­ple of new hires with the ap­point­ments of Andy Kil­ian­s­ki as se­nior di­rec­tor for emerg­ing in­fec­tious dis­eases and Lew Schrager as tu­ber­cu­lo­sis im­pact area se­nior leader. Kil­ian­s­ki comes aboard with ex­pe­ri­ence from his time as a for­mer De­part­ment of De­fense se­nior sci­en­tist and pro­gram man­ag­er. Mean­while, Schrager brings to the ta­ble skills from his time as a con­sul­tant to the WHO and Tu­ber­cu­lo­sis Vac­cine Ini­tia­tive and as VP of sci­en­tif­ic af­fairs at Aeras.

Steven Gal­son

Alex Zha­voronkov hauled in a mas­sive new chunk of change at In­sil­i­co$255 mil­lion of it, to be ex­act — and now has brought on for­mer act­ing Sur­geon Gen­er­al Steven Gal­son as an in­de­pen­dent mem­ber of the AI drug dis­cov­ery play­er’s board of di­rec­tors. Gal­son, once the CDER di­rec­tor from 2001-07, just re­tired from Am­gen af­ter near­ly 11 years as an ex­ec in glob­al reg­u­la­to­ry af­fairs and strat­e­gy, glob­al pa­tient safe­ty and R&D.

Mick­ey Mik­i­tani’s Rakuten Med­ical, two weeks re­moved from a $166 mil­lion Se­ries D to get its lead can­cer drug in­to a glob­al Phase III tri­al, has added Nitin Nohria and Hi­roshi Taka­sawa to its board of di­rec­tors. Nohria, for­mer dean of the Har­vard School of Busi­ness, will serve as chair­man of the board. Taka­sawa, CEO of Rakuten Asia, has been a part of var­i­ous ven­tures since join­ing Rakuten in 2005, in­clud­ing the com­pa­ny’s M&A deals.

→ Ex-No­vo Nordisk glob­al CMO Alan Moses has been added to the board of di­rec­tors at En­terin out of Philadel­phia. Moses, who spent 14 years with No­vo, al­so joined the boards of Bio­mX and Chemomab Ther­a­peu­tics with­in the last year.

Si­mon Sturge

→ The for­mer CEO of Kymab, Si­mon Sturge, has made his way on­to the board of di­rec­tors at Swiss-based Moon­Lake Im­munother­a­peu­tics as chair­man. Pri­or to his role at Kymab, Sturge was with Mer­ck KGaA as COO and served at Boehringer In­gel­heim, Cell­tech Bi­o­log­ics and Ri­b­o­tar­gets. In ad­di­tion to Sturge’s ap­point­ment, the com­pa­ny has pulled in Spike Loy as a mem­ber of the board. Loy is man­ag­ing di­rec­tor at BVF Part­ners.

Tar­sus Phar­ma­ceu­ti­cals, which re­leased “clin­i­cal­ly mean­ing­ful” Phase II/III da­ta for its De­mod­ex ble­phar­i­tis drug in June, has re­served a seat for Rose­mary Crane on the board of di­rec­tors. Crane, the for­mer group chair­man of the OTC & nu­tri­tion­al group at J&J who was with Bris­tol My­ers from 1982-2002, is on the boards at Catal­ent and Te­va.

Melis­sa Starovas­nik

→ Twist and shout: Melis­sa Starovas­nik has signed on to the board of di­rec­tors at Twist Bio­science, the syn­thet­ic bi­ol­o­gy out­fit that de­cid­ed to pump up the square footage on its so-called “Fac­to­ry of the Fu­ture” in Ore­gon from 110,000 to 190,000. In her 28 years at Genen­tech, Starovas­nik held such roles as VP, pro­tein sci­ences, head of large mol­e­cule drug dis­cov­ery and se­nior sci­en­tif­ic ad­vi­sor, re­search.

→ Long­time No­var­tis vet Ameet Mallik, who had been head of US on­col­o­gy for No­var­tis On­col­o­gy from 2017 un­til this April, makes his way to the board of di­rec­tors at Atara Bio­ther­a­peu­tics. Mallik is now CEO of Rafael Hold­ings, which merged with Rafael Phar­ma­ceu­ti­cals at the be­gin­ning of the sum­mer.

Heather Franklin

XO­MA has reeled in the CEO and pres­i­dent of Blaze Bio­science, Heather Franklin to its board of di­rec­tors. Pri­or to her role at Blaze, Franklin was with Zy­mo­Ge­net­ics, Am­gen and Tar­get­ed Ge­net­ics.

Ser­ax­is has added a few more seats to its board of di­rec­tors with the ap­point­ments of Shel­ley Hart­man, Jer­ry Baty and Min-Jung Choi.  Hart­man is the cur­rent CEO of Ae­gle Ther­a­peu­tics and a for­mer man­ag­ing di­rec­tor at Gold­man Sachs. Mean­while, Baty is a part­ner at New­port and the for­mer CEO of SafeTech USA. Last, but not least, Choi is a se­nior fi­nance man­ag­er at Me­dy­tox.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi calls it quits on mR­NA Covid-19 shots, scrap­ping vac­cine from $3.2B Trans­late Bio buy­out

Sanofi is throwing in the towel on mRNA-based Covid-19 vaccines.

The French drugmaker will halt development on its unmodified mRNA Covid-19 shot despite what it said were positive Phase I/II results, a spokesperson told Endpoints News on Tuesday morning. Sanofi said the reason it’s stopping the Covid-19 mRNA program, developed in partnership with its new $3.2 billion acquisition Translate Bio, is because the market is too crowded.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

Tur­moil at CBER: Pe­ter Marks grabs con­trol of FDA's Of­fice of Vac­cines ahead of 2 key ca­reer leader de­par­tures

FDA’s top vaccine official Peter Marks is pulling the plug on a months-long transition for two top career vaccine officials who abruptly called it quits in late August.

Marion Gruber, director of the FDA’s Office of Vaccines Research & Review and 32-year veteran of the agency, her deputy director Phil Krause, announced their departures and then raised concerns with Covid-19 booster shots ahead of and during a recent Covid-19 booster vaccine advisory committee.