Ex-As­traZeneca ex­ec Kris­ten Buck hops aboard Icon as CMO; Im­muno­core taps Bri­an Di­Do­na­to as CFO

Kris­ten Buck

→ Promi­nent CRO play­er Icon is bol­ster­ing its lead­er­ship, with Kris­ten Buck tak­ing the reins as CMO.

For slight­ly more than a year and a half, Buck was the SVP & chief of clin­i­cal de­vel­op­ment at Op­tum, part of the Unit­ed­Health con­glom­er­ate. When she got there, she had al­ready held a post at the FDA in the gas­troin­testi­nal and hema­tol­ogy di­vi­sion, tasked with post-mar­ket­ing safe­ty for over 40 drugs. She had al­so spent 6 years as an ex­ec at As­traZeneca in clin­i­cal de­vel­op­ment and in its in­no­v­a­tive med­i­cines group.

Her back­ground cov­ers an ar­ray of ther­a­py ar­eas, in­clud­ing GI, women’s health, oph­thal­mol­o­gy, neu­ro­science, der­ma­tol­ogy, on­col­o­gy, liv­er, or­phan dis­eases and psy­chi­a­try.

Buck was a track and field ath­lete at the Uni­ver­si­ty of Vir­ginia and then moved on to Penn State to re­ceive her MD. She stayed in Penn­syl­va­nia to com­plete her in­tern­ship and res­i­den­cy in in­ter­nal med­i­cine at Abing­ton Memo­r­i­al Hos­pi­tal.

Dublin-based Icon won Best Con­tract Re­search Or­ga­ni­za­tion (full-ser­vice providers) in De­cem­ber at the Scrip Awards in Lon­don.

“I’m ex­cit­ed to be lead­ing ICON’s po­si­tion on clin­i­cal de­vel­op­ment trends, and re­view­ing and ad­vis­ing on our med­ical risks as the world wres­tles with the Covid-19 pan­dem­ic,” Buck said in a state­ment. “Pa­tient cen­tric­i­ty is ever more im­por­tant in the cur­rent cli­mate and I look for­ward to work­ing with the wider ICON team to broad­en our in­sights and ex­pand our ex­per­tise.”

Bri­an Di­Do­na­to has jumped in as CFO and head of strat­e­gy of TCR-fo­cused Im­muno­core, which is mov­ing on from Neil Wood­ford af­ter scor­ing a $130 bil­lion Se­ries B haul in March. Di­Do­na­to was most re­cent­ly the SVP and CFO at Achillion Phar­ma­ceu­ti­cals, ac­quired by Alex­ion. Oth­er pre­vi­ous stops for Di­Do­na­to in­clude Sorin Cap­i­tal Man­age­ment, Cap­mark In­vest­ments as pres­i­dent and chief in­vest­ment of­fi­cer, Mor­gan Stan­ley and UBS Se­cu­ri­ties.

→ While work­ing to­wards its goal of pro­duc­ing 1 bil­lion vac­cines to fight Covid-19, as well as be­ing the com­pa­ny with one of the lead­ing vac­cines now in the clin­ic, Mod­er­na has ramped up its team with some new ap­point­ments. This comes af­ter news of their CFO Lorence Kim hit­ting the ex­it af­ter 6 years with the Boston-based up­start. Patrick Berg­st­edt, Jacque­line Miller and Char­bel Haber have all hopped aboard to help with the com­pa­ny’s light­ning-fast cam­paign. Berg­st­edt, a Mer­ck vet, is step­ping in as SVP for com­mer­cial vac­cines; Miller hails from GSK and comes in as SVP of in­fec­tious dis­ease de­vel­op­ment and Haber, mean­while, leaps over from Bio­gen as SVP of reg­u­la­to­ry af­fairs.

Na­jat Khan

→ Over at J&J, Na­jat Khan has tran­si­tioned in­to the role of chief da­ta sci­ence of­fi­cer. Pre­vi­ous­ly, Khan had served as the COO in the re­search arm. R&D chief Math­ai Mam­men praised Khan for her bilin­gual ex­per­tise in two key lan­guages: the sci­ence of drug de­vel­op­ment as well as da­ta sci­ences. And han­dled prop­er­ly, that can guide R&D to more wins with low­er costs — a long­time mantra in a world where ROI is gen­er­al­ly sore­ly lack­ing. Pri­or to jump­start­ing her role at J&J, Khan served as a phar­ma con­sul­tant at the Boston Con­sult­ing Group.

→ Sin­ga­pore biotech Tes­sa Ther­a­peu­tics, which fo­cus­es on can­cer cell ther­a­pies, has un­der­gone a few lead­er­ship changes. An­drew Khoo has stepped aside as CEO but will re­main on Tes­sa’s board, and Jef­frey Buchal­ter, a board mem­ber since last March, has suc­ceed­ed him. Buchal­ter has been pres­i­dent and CEO of Archimedes Phar­ma­ceu­ti­cals, En­zon Phar­ma­ceu­ti­cals and Ilex On­col­o­gy. Chair­man of the board Teo Ming Kian al­so stepped down ef­fec­tive May 1, with for­mer No­vo Nordisk chair­man Göran An­do set to take his place.

Jef­frey Buchal­ter

→ Ex­pand­ing his role at CNS-fo­cused Im­pel Neu­roPhar­ma, Adri­an Adams is now the chair­man and CEO ef­fec­tive im­me­di­ate­ly, re­plac­ing Jon Con­gle­ton. Adams was named chair­man of Im­pel’s board in Jan­u­ary, and be­fore then, he held nu­mer­ous CEO posts, in­clud­ing at Ar­alez Phar­ma­ceu­ti­cals, Aux­il­i­um Phar­ma­ceu­ti­cals (un­til its ac­qui­si­tion by En­do In­ter­na­tion­al plc) and Neu­rologix.

→ Along with chang­ing its name, Trovagene is do­ing some C-suite shuf­fling. Now called Cardiff On­col­o­gy, the San Diego-based pre­ci­sion can­cer meds com­pa­ny de­vel­op­ing the can­cer drug on­va­nsert­ib is pro­mot­ing Mark Er­lan­der to CEO, while Thomas Adams tran­si­tions from chair­man and CEO to ex­ec­u­tive chair­man. Er­lan­der had been the for­mer Trovagene’s CSO since 2013.

Mark Er­lan­der

Tim­o­thy Jones will lead Respir­eRx Phar­ma­ceu­ti­cals as pres­i­dent and CEO, re­plac­ing Arnold Lip­pa, who served in those ca­pac­i­ties on an in­ter­im ba­sis. Lip­pa stays on as ex­ec­u­tive chair­man and CSO. Since Jan­u­ary, Jones had been on the board of Respir­eRx, which tar­gets treat­ment op­tions for such con­di­tions as ob­struc­tive sleep ap­nea and AD­HD, and or­phan dis­eases such as Frag­ile X syn­drome. Jones heads to Respir­eRx from Purisys, where he was VP of glob­al phar­ma­ceu­ti­cal and med­ical OTC.

Ra­jiv Khosla has been se­lect­ed as CEO of NJ-based En­teris Bio­Phar­ma, re­plac­ing Joel Tune, who had been CEO the last four years. Be­fore he be­gan at En­teris, which de­vel­oped oral de­liv­ery tech­nol­o­gy called Peptel­li­gence, Khosla found­ed Ceutec, a busi­ness de­vel­op­ment con­sul­tan­cy that served bio­phar­mas and VCs. He was al­so at Bio­vail as VP of busi­ness de­vel­op­ment.

Tony Gib­ney

→ Last year around this time, Fog­Phar­ma in­tro­duced CSO Howard Stern. This week the Mass­a­chu­setts biotech has a new CFO and CBO in Tony Gib­ney, the for­mer EVP and CBO of Achillion who led the com­pa­ny’s sale to Alex­ion. Be­fore Achillion, Gib­ney’s life sci­ence in­vest­ment bank­ing ex­pe­ri­ence in­cludes stints at SVB Leerink, Mer­rill Lynch and Lehman Broth­ers.

→ Mi­lan-based Pin­Cell, which tar­gets rare der­ma­to­log­i­cal dis­eases and raised €1.65 mil­lion in seed fi­nanc­ing led by Sofinno­va Part­ners, has named Gabriel­la Cam­boni as CEO and will be a mem­ber of the board of di­rec­tors. Nordic Nanovec­tor CEO Lui­gi Cos­ta has al­so been pegged as chair­man of Pin­Cell’s board, and Pao­la Pozzi, a part­ner at Sofinno­va Part­ners, will al­so join as a board mem­ber.

Chris­tine Matthews

→ With the FDA ac­cept­ing the NDA for its mi­graine drug Qtryp­ta in March, Zosano Phar­ma has se­lect­ed Chris­tine Matthews as CFO. She was the Cal­i­for­nia bio­phar­ma’s in­ter­im CFO since Feb­ru­ary and was an ac­count­ing and fi­nan­cial con­sul­tant with RGP be­fore her time with Zosano. Matthews was al­so di­rec­tor of fi­nan­cial plan­ning & analy­sis at Cepheid and be­gan her ca­reer at Arthur An­der­sen.

Dou­glas Pagán is mov­ing to Dicer­na to be­come CFO, ef­fec­tive May 26. Be­fore join­ing Dicer­na, which an­nounced an RNAi col­lab­o­ra­tion with Al­ny­lam in April for al­pha 1 liv­er dis­ease, Pagán will wrap up his tenure as CFO and sec­re­tary of KSQ Ther­a­peu­tics. Pri­or to that, he was CFO of Paratek Phar­ma­ceu­ti­cals for five years.

→ A cou­ple of new moves have been made at Spruce Bio­sciences, which re­leased pos­i­tive re­sults in Sep­tem­ber from its Phase II study of its lead can­di­date tildac­er­font in adults with con­gen­i­tal adren­al hy­per­pla­sia. Samir Gharib joins the team as CFO, com­ing from Stemed­ica Cell Tech­nolo­gies where he had the same role. Mean­while, Dasharatha Red­dy is on board as VP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing. She was pre­vi­ous­ly head of CMC at Lan­dos Bio­phar­ma.

An­drew Guggen­hime

→ Fresh off $100 mil­lion Se­ries D fi­nanc­ing to help take its Pre­vnar 13 ri­val SVX-24 to the clin­ic, SutroVax has wel­comed An­drew Guggen­hime as CFO and CBO. Guggen­hime was Demi­ra’s CFO from 2014 un­til Eli Lil­ly ac­quired the com­pa­ny in Feb­ru­ary. He has a pletho­ra of oth­er CFO roles to his cred­it, in­clud­ing at Car­dioDx, Cal­is­to­ga Phar­ma­ceu­ti­cals and Facet Biotech Cor­po­ra­tion.

→ Can­cer ther­a­py-fo­cused An­chi­ano is ap­point­ing Steve Di­Pal­ma as its CFO. Di­Pal­ma had been a se­nior fi­nan­cial ad­vi­sor to Cam­bridge, MA-based An­chi­ano the last two years, in ac­cor­dance with Dan­forth Ad­vi­sors. His pre­de­ces­sor, Jonathan Bur­gin, is leav­ing as the biotech clos­es its Is­rael of­fices and fa­cil­i­ties. Di­Pal­ma has held lead­er­ship roles at nu­mer­ous com­pa­nies, in­clud­ing Fo­rum Phar­ma­ceu­ti­cals, RXi Phar­ma­ceu­ti­cals, and at Cat­a­lyst On­col­o­gy, where he was pres­i­dent and CEO.

→ For­mer Pfiz­er ex­ec Robert Fo­er­ster has signed on to be CFO at Oligomer­ix, a Bronx biotech de­vel­op­ing nov­el ther­a­peu­tics for Alzheimer’s dis­ease and re­lat­ed neu­rode­gen­er­a­tive dis­or­ders. Dur­ing his tenure with the phar­ma gi­ant, Fo­er­ster as­sumed such roles as se­nior di­rec­tor, com­mer­cial de­vel­op­ment for emerg­ing mar­kets and se­nior di­rec­tor of Pfiz­er Japan’s busi­ness de­vel­op­ment di­vi­sion.

→ With its Neu­trox fam­i­ly of prod­ucts that in­cludes Aven­o­va and CelleRx, Nov­aBay Phar­ma­ceu­ti­cals has a new CFO. An­drew Jones has jumped on board to re­place the in­ter­im CFO, Lynn Christo­pher, who con­tin­ues in a con­sul­tan­cy role. Jones was pre­vi­ous­ly VP, fi­nance of MyoScience for a lit­tle over a year un­til Paci­ra Bio­Sciences ac­quired it last Au­gust.

→ Speak­ing of Paci­ra Bio­sciences, which fo­cus­es on non-opi­oid treat­ments, the com­pa­ny has brought in Don­ald Man­ning to be CMO. Man­ning had been CMO of Ad­ynxx since 2012, and he al­so held po­si­tions at No­var­tis (glob­al head of anal­gesics de­vel­op­ment) and Cel­gene (VP and neu­ro­sciences ther­a­peu­tic area head).

Noreen Henig

→ Af­ter CMO stints at Breath Ther­a­peu­tics and Pro­QR Ther­a­peu­tics, Noreen Henig is tak­ing on the same CMO role at Kezar Life Sci­ences, which fo­cus­es on treat­ments for au­toim­mune dis­eases and can­cer. Pri­or to Pro­QR, Henig spent six years at Gilead, no­tably as se­nior di­rec­tor, glob­al med­ical af­fairs, res­pi­ra­to­ry and PAH.

→ Pa­lo Al­to-based Life­Max Lab­o­ra­to­ries, which in April was grant­ed fast track des­ig­na­tion for LM-030 li­censed from No­var­tis and in a Phase II/III piv­otal clin­i­cal tri­al for treat­ing Nether­ton syn­drome, has tapped Michael Huang as its CMO. Huang was CMO of Spruce Bio­sciences and was pre­vi­ous­ly VP of clin­i­cal de­vel­op­ment at both Reg­u­lus Ther­a­peu­tics and Aus­pex Phar­ma­ceu­ti­cals.

GSK vet Ian Catch­pole has land­ed the CSO po­si­tion at Ho­ra­ma af­ter some con­sult­ing work and a gig as di­rec­tor of re­search at TC Bio­pharm. Catch­pole was at GSK for 25 years, cap­ping his tenure as “cell and gene ther­a­py dis­cov­ery” trans­la­tion­al leader and by be­ing named a GSK Fel­low in 2016. His ex­per­tise al­so ex­tends to oph­thal­mol­o­gy, vac­ci­na­tion and im­muno-on­col­o­gy.

Elaine Jones

→ Los An­ge­les biotech Myst Ther­a­peu­tics, which de­vel­ops se­lect­ed TIL-based au­tol­o­gous T cell (Pu­riT) ther­a­py prod­ucts for can­cer, has tapped George Smith as VP of busi­ness op­er­a­tions. Smith was the founder and in­te­grat­ed pro­gram lead at Iqvia’s Gene Ther­a­py Cen­ter and their se­nior di­rec­tor, port­fo­lio and in­no­va­tion.

→ Im­munother­a­py-fo­cused Grit­stone On­col­o­gy has ap­point­ed Elaine Jones as chair of the board of di­rec­tors. From 2008 to 2019, Jones was vice pres­i­dent, world­wide busi­ness de­vel­op­ment and se­nior part­ner at Pfiz­er Ven­tures and has been gen­er­al part­ner at Eu­clid­SR Part­ners.

Nordic Nanovec­tor is reshuf­fling its ex­ec team in an ef­fort of cost-sav­ing ini­tia­tives an­nounced in ear­ly April. CFO Tone Kvåle and chief hu­man re­sources of­fi­cer Ri­ta Dege have part­ed ways with the com­pa­ny. Mean­while, Ma­lene Brond­berg, VP in­vestor re­la­tions and cor­po­ra­tion com­mu­ni­ca­tions, has been ap­point­ed CFO. Brond­berg joined the com­pa­ny in Feb­ru­ary 2018 and brought ex­pe­ri­ence from her time with The re­struc­tur­ing has re­duced the num­ber of ex­ec­u­tives from nine to sev­en.

Codex­is has filled two new­ly-cre­at­ed po­si­tions. Ste­fan Lutz has stepped in as SVP, re­search, and Karl Schoene is al­so div­ing in as SVP, de­vel­op­ment and op­er­a­tions. Lutz was a pro­fes­sor and chair of the chem­istry de­part­ment at Emory, while Schoene had pre­vi­ous­ly been pres­i­dent, CEO and di­rec­tor of El­e­vance Re­new­able Sci­ences.

→ Part­ner­ing with Pfiz­er on its an­ti­sense ther­a­py AKCEA-ANGPTL3-LRx, Akcea Ther­a­peu­tics has cho­sen Car­la Poul­son as SVP and chief hu­man re­sources of­fi­cer. Poul­son makes the tran­si­tion to Akcea, ma­jor­i­ty owned by Io­n­is, from Ver­tex, where she was VP, se­nior hu­man re­sources busi­ness part­ner.

Stephen Mi­gausky Imara

→ Af­ter the an­nounce­ment of their CMO hit­ting the ex­it late last month, NEA-found­ed Imara has added Stephen Mi­gausky to the ranks as SVP, le­gal and gen­er­al coun­sel. Pri­or to join­ing Imara, Mi­gausky served as gen­er­al coun­sel at Ar­Qule and has pre­vi­ous­ly served in roles at Ver­tex.

Scott Byrd, Ian Mills and Gor­don Mc­Mur­ray have joined Fra­zier Health­care Part­ners as en­tre­pre­neur-in-res­i­dence con­sul­tants. The three were pre­vi­ous­ly a part of the man­age­ment team at Fra­zier port­fo­lio com­pa­ny Out­post Med­i­cine and served as CEO, CMO and CSO re­spec­tive­ly. They have re­cent­ly formed Pi­o­neer Ther­a­peu­tics. For­mer­ly, Byrd was pres­i­dent and COO at Aca­cia Phar­ma; Mills was head of clin­i­cal de­vel­op­ment at Mit­subishi Tan­abe Phar­ma Eu­rope and Mc­Mur­ray had a stint at Pfiz­er Glob­al R&D.

→ Next-gen T cell play­er TCR² Ther­a­peu­tics — which snagged a $75M IPO last year — has added Stephen Web­ster, the for­mer CFO of Spark Ther­a­peu­tics, to its board of di­rec­tors. Web­ster will take over for Mitchell Fin­er who is step­ping down from the board.

Stephen Web­ster

→ Af­ter rais­ing $200M-plus for their IPO in Feb­ru­ary, drug dis­cov­ery soft­ware play­er Schrödinger has wel­comed Jef­frey Chodake­witz and Gary Gins­berg to its board of di­rec­tors. Chodake­witz pre­vi­ous­ly held posts at Ver­tex and Mer­ck, while Gins­berg served stints at Time Warn­er and Soft­bank Group.

ALX On­col­o­gy, which de­vel­ops ther­a­pies that block the CD47 check­point path­way, has ap­point­ed Rekha Hem­ra­jani to its board of di­rec­tors. Hem­ra­jani is the pres­i­dent and CEO of Ar­a­vive and the for­mer COO and CFO of Ar­cus Bio­sciences.

Re­cur­sion, which bills it­self as the first AI biotech to launch hu­man tri­als, has en­list­ed R Mar­tin Chavez and Ter­ry-Ann Bur­rell to its board of di­rec­tors. Chavez is the for­mer CFO, chief in­for­ma­tion of­fi­cer and glob­al co-head of the se­cu­ri­ties di­vi­sion at Gold­man Sachs and Bur­rell cur­rent­ly serves as CFO of Beam Ther­a­peu­tics.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; 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.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.