Bob Goeltz bolts Uni­ty Biotech­nol­o­gy to be­come CFO at Ar­cus Bio­sciences; John John­son tapped for his lat­est CEO gig

Bob Goeltz

→ A press re­lease ear­li­er in the week not­ed that Bob Goeltz left his CFO post at Uni­ty Biotech­nol­o­gy “to pur­sue a new op­por­tu­ni­ty.” We now know what that op­por­tu­ni­ty is, join­ing Ter­ry Rosen’s crew at Ar­cus Bio­sciences as the new CFO. A for­mer ex­ec­u­tive di­rec­tor of cor­po­rate de­vel­op­ment at Am­gen, Goeltz was the CFO for Cy­tomX Ther­a­peu­tics be­fore mak­ing the move to an­ti-ag­ing start­up Uni­ty in 2017.

“With the po­ten­tial to have three mol­e­cules in reg­is­tra­tional stud­ies in 2021, a pro­lif­ic dis­cov­ery team and a unique­ly en­abling and nascent al­liance with Gilead, Bob joins Ar­cus at a sem­i­nal in­flec­tion point, with the op­por­tu­ni­ty to make Ar­cus’s vi­sion of cre­at­ing, de­vel­op­ing and com­mer­cial­iz­ing in­no­v­a­tive and cu­ra­tive ther­a­pies for can­cer a re­al­i­ty,” Rosen said in a state­ment.

Lynne Sul­li­van

Mean­while, Uni­ty Biotech­nol­o­gy has se­lect­ed Bio­gen vet Lynne Sul­li­van to re­place Goeltz as their in­ter­im CFO, ef­fec­tive Au­gust 1. Sul­li­van is on the board of di­rec­tors and chairs the au­dit com­mit­tee at Sol­id Bio­sciences, resTOR­bio and Bio­mX. A for­mer CFO at Com­pass Ther­a­peu­tics, she spent more than 10 years at Bio­gen, leav­ing as their SVP of fi­nance.

→ La Jol­la, CA-based biotech CEND Ther­a­peu­tics is mak­ing a change at the top, with David Slack tak­ing over as pres­i­dent and CEO of the can­cer-fo­cused com­pa­ny. A board mem­ber since last year, Slack takes the place of co-found­ing CEO Erk­ki Ru­oslahti, who will still be chair­man and a se­nior ad­vi­sor. The co-founder and ex-CEO of Ki­na­gen, Slack al­so spent 4 years as CBO of Virac­ta Ther­a­peu­tics.

John John­son

John John­son has agreed to be CEO of the rare dis­ease biotech Strong­bridge Bio­phar­ma — the lat­est in a long string of CEO posts. John­son had been Strong­bridge’s chair­man for the last 5 years and brings sub­stan­tial C-suite clout as the ex-CEO of Melin­ta Ther­a­peu­tics and Den­dreon. His record on turn­around at­tempts, though, has been bleak. His oth­er pre­vi­ous lead­er­ship po­si­tions run the gamut in Big Phar­ma, from his tenure at Eli Lil­ly as pres­i­dent of glob­al on­col­o­gy to his time at J&J as com­pa­ny group chair­man, world­wide bio­phar­ma­ceu­ti­cals.

→ Con­sid­er­able per­son­nel moves are play­ing out at Rea­ta, the Texas bio­phar­ma that had to press pause in late March both on their Phase III tri­al for bar­dox­olone in CTD-PAH and on en­roll­ment for the FAL­CON tri­al of bar­dox­olone to treat pa­tients with au­to­so­mal dom­i­nant poly­cys­tic kid­ney dis­ease. First up: Col­in Mey­er has been pro­mot­ed to the new po­si­tion of chief re­search and de­vel­op­ment of­fi­cer and EVP. Mey­er start­ed at Rea­ta in 2003, fill­ing a va­ri­ety of roles be­fore climb­ing to the CMO post in 2013. See­mi Khan suc­ceeds Mey­er as CMO, com­ing off 3 years at Mit­subishi Ten­abe as their de­vel­op­ment team lead. She al­so spent time as the se­nior med­ical di­rec­tor, glob­al R&D for Ab­b­Vie.

Ad­di­tion­al­ly, Kevin John­ston has made his way to Rea­ta as VP and chief tech­ni­cal of­fi­cer. John­ston was most re­cent­ly the VP of sup­ply chain & lo­gis­tics at Tesaro. Fi­nal­ly, An­drea Loewen is now Rea­ta’s VP, glob­al reg­u­la­to­ry af­fairs, bring­ing more than 30 years of reg­u­la­to­ry ex­pe­ri­ence with such com­pa­nies as Bio­gen, Shire and Bax­ter Health­care.

Matthew Os­borne

→ It’s al­so a busy week of ex­ec­u­tive shuf­fling at On­colo­gie as Matthew Os­borne as­sumes the role of CFO, Hagop Yous­soufi­an steps in as in­ter­im CMO, Bill Mc­Don­ald is now VP, CMC, and Ker­ry Culm-Merdek, gets pro­mot­ed to VP of clin­i­cal de­vel­op­ment.

Os­borne leaves a bat­tered Unum Ther­a­peu­tics, where he was their CFO, and be­fore that, he served as head of cor­po­rate af­fairs, com­mu­ni­ca­tions and in­vestor re­la­tions at Voy­ager Ther­a­peu­tics. Yous­soufi­an’s last CMO gig was at BIND Ther­a­peu­tics and he for­mer­ly led ex­per­i­men­tal med­i­cine at Bris­tol My­ers Squibb. Mc­Don­ald most re­cent­ly held the same role of VP, CMC at Con­tra­fect, and be­fore join­ing On­colo­gie, Culm-Merdek was head of clin­i­cal phar­ma­col­o­gy & quan­ti­ta­tive bio­an­a­lyt­ics at Im­muno­Gen.

→ Putting them­selves in the Covid-19 hunt with lenzilum­ab’s po­ten­tial to quash the cy­tokine storms that can af­flict pa­tients, Hu­mani­gen has a trio of new ex­ecs. Dale Chap­pell, who found­ed Black Horse Cap­i­tal, has signed on as the Cal­i­for­nia phar­ma’s CSO. David Tou­s­ley, the ex-CFO at a host of com­pa­nies in­clud­ing Avax Tech­nolo­gies and Dara Bio­sciences, has been named Hu­mani­gen’s chief ac­count­ing of­fi­cer. And Omar Ahmed, a No­var­tis and Roche vet and for­mer glob­al mar­ket­ing leader, im­munol­o­gy at Janssen, has been pro­mot­ed to SVP, clin­i­cal, med­ical and sci­en­tif­ic af­fairs.

Richard Williams

Kin­nate Bio­phar­ma, which jumped in­to the scene last De­cem­ber with a hefty $74.5 mil­lion B round, has en­list­ed Richard Williams as CMO. Williams hails from WuXi NextCODE, where he served as CMO and glob­al head of on­col­o­gy pro­grams. Pre­vi­ous­ly, Williams has served in roles at GRAIL and Puma Biotech­nol­o­gy. In ad­di­tion, the San Diego-based com­pa­ny tapped Pfiz­er vet Robert Ka­nia as SVP, drug dis­cov­ery.

→  To ini­ti­ate busi­ness de­vel­op­ment in the US, French biotech Im­Check Ther­a­peu­tics — which se­cured $53 mil­lion in Se­ries B fi­nanc­ing last De­cem­ber — has named Claude Knopf as CBO. Knopf brings ex­pe­ri­ence from his time spent at Gem­i­ni Ther­a­peu­tics, Pieris Phar­ma­ceu­ti­cals, Bax­ter Bio­science and No­var­tis.

Join­ing forces with J&J in the field of gam­ma delta T cells, Dutch biotech La­va Ther­a­peu­tics has wel­comed Ben­jamin Wino­grad as CMO. Wino­grad was for­mer­ly Cel­gene’s clin­i­cal re­search and de­vel­op­ment ther­a­peu­tic area head for mul­ti­ple myelo­ma.

→ Au­toim­mune dis­ease-fo­cused IM Ther­a­peu­tics has bol­stered its se­nior man­age­ment team with Tom Shea com­ing in as CFO and COO, along with the pro­mo­tion of Sarah Bird to VP, clin­i­cal de­vel­op­ment. Shea was pre­vi­ous­ly the CFO at Im­mu­sanT, which tar­gets celi­ac dis­ease and type 1 di­a­betes, and has al­so been CFO of Al­bireo Phar­ma, Tol­erx and Cu­bist Phar­ma­ceu­ti­cals. Bird was on board at IM Ther­a­peu­tics from its found­ing as di­rec­tor, clin­i­cal de­vel­op­ment, and al­so led glob­al pro­grams when she was a clin­i­cal re­search sci­en­tist at Gilead.

Chris Mora­bito

→ Af­ter Pe­ter Lawrence took the helm as pres­i­dent and CEO in April, Car­du­ri­on Phar­ma­ceu­ti­cals has nabbed Big Phar­ma vet Chris Mora­bito as their new CMO. Mora­bito had held sev­er­al roles at Take­da the last 4 years, and was most re­cent­ly their head of R&D, plas­ma-de­rived ther­a­pies and was a key leader in the Shire ac­qui­si­tion while he was head of pipeline strat­e­gy for glob­al R&D. Be­fore Take­da, Mora­bito spent time at Sanofi and Mer­ck.

Akcea Ther­a­peu­tics, which boast­ed pos­i­tive Phase II da­ta in Jan­u­ary for their drug AKCEA-ANGPTL3-LRx in pa­tients with hy­per­triglyc­eridemia, has ap­point­ed William An­drews as CMO af­ter gain­ing Michael Price as their new CFO in May. Pri­or to his role at Akcea, An­drews had been the CMO at Ac­er Ther­a­peu­tics since 2017. He al­so pro­vid­ed con­sul­ta­tion at Aletheia Bio­sciences and held po­si­tions at Aege­ri­on Phar­ma­ceu­ti­cals.

Richard Shea is re­tir­ing from the CFO post at Syn­dax Phar­ma­ceu­ti­cals, the Waltham, MA com­pa­ny look­ing to shake off last year’s tri­al set­backs in com­bo stud­ies in­volv­ing endi­no­s­tat with Tecen­triq and Baven­cio. Shea has been re­placed by Daphne Kary­das, who gets start­ed Mon­day af­ter be­ing SVP of cor­po­rate fi­nan­cial plan­ning & analy­sis and strat­e­gy at Al­ler­gan. She be­gan her ca­reer as a project chem­i­cal en­gi­neer at Mer­ck be­fore go­ing to Gold­man Sachs as a VP fo­cused on health care.

Michael Amoroso

→ Restart­ing en­roll­ment this week for its piv­otal Phase III study of EB-101 to treat re­ces­sive dy­s­troph­ic epi­der­mol­y­sis bul­losa (RDEB), Abeona Ther­a­peu­tics has brought on Michael Amoroso to be their chief com­mer­cial of­fi­cer. Amoroso was pre­vi­ous­ly SVP and head of world­wide com­mer­cial, cell ther­a­py at Kite. He al­so held sev­er­al roles at Cel­gene and was SVP, Amer­i­c­as for the com­mer­cial on­col­o­gy busi­ness group at Ei­sai.

AVM Biotech­nol­o­gy — whose lead mol­e­cule, AVM0703, has re­ceived FDA per­mis­sion to be­gin clin­i­cal tri­als treat­ing no-op­tion Non-Hodgkin’s Lym­phoma — has tapped Janet Rea as COO. Rea hops aboard the Seat­tle-based biotech with ex­pe­ri­ence from her roles at Im­munex, MDS Phar­ma, AVI Bio­Phar­ma (now Sarep­ta) and Atossa Ther­a­peu­tics among oth­ers.

→ These days, it wouldn’t be Peer Re­view with­out some­thing from No­vavax. The new faces and pro­mo­tions keep on truck­ing as the biotech con­tin­ues to re­tool the team and make news, as they did this week with their $1.6 bil­lion Op­er­a­tion Warp Speed deal. This time it’s Frank Cz­wor­ka get­ting the nod as SVP, glob­al sales and Bri­an Webb get­ting the bump to SVP, man­u­fac­tur­ing. Cz­wor­ka had been VP, glob­al cus­tomer en­gage­ment at US Phar­ma­copeia af­ter 5 years in lead­er­ship roles at Osiris Ther­a­peu­tics. Webb joined No­vavax back in 2014 from GSK, where he was the phar­ma gi­ant’s se­nior man­ag­er, com­mer­cial man­u­fac­tur­ing.

Narinder Singh

→ Cal­i­for­nia-based Aim­mune, which won ap­proval from the FDA in Jan­u­ary with Pal­forzia to treat peanut al­ler­gy, has brought in Am­gen vet Narinder Singh to be EVP of tech­ni­cal op­er­a­tions. Singh left Geno­cea Bio­sciences, where he was SVP, phar­ma­ceu­ti­cal sci­ences and man­u­fac­tur­ing since March 2018. Af­ter 18 years in process de­vel­op­ment at Am­gen, Singh was al­so VP, drug prod­uct de­vel­op­ment & man­u­fac­tur­ing at Mo­men­ta Phar­ma­ceu­ti­cals from 2015-18.

Ab­by Bron­son

→ Less than a month af­ter nam­ing Kirsten Gruis as CMO, Col­orado-based mus­cu­loskele­tal dis­ease biotech Edge­wise Ther­a­peu­tics has made Ab­by Bron­son VP, pa­tient ad­vo­ca­cy and ex­ter­nal in­no­va­tion, a new­ly-cre­at­ed po­si­tion. For 4 years, Bron­son was pre­vi­ous­ly at Par­ent Pro­ject Mus­cu­lar Dy­s­tro­phy (PP­MD) as their SVP of re­search strat­e­gy. She’s al­so been in the clin­i­cal in­no­va­tion di­vi­sion at NIH’s Cen­ter for Ad­vanc­ing Trans­la­tion­al Sci­ences.

Organon & Co., Mer­ck’s in­tend­ed spin­off of its women’s health, lega­cy brands and biosim­i­lars busi­ness­es, has named Deb­o­rah Tel­man their gen­er­al coun­sel. An Ab­bott vet, Tel­man jumps to Organon from Sor­ren­to Ther­a­peu­tics, where she was SVP, gen­er­al coun­sel & cor­po­rate Sec­re­tary.

Denelle Wayn­ick

Denelle Wayn­ick is head­ed to MyoKar­dia, which re­vealed stel­lar Phase III da­ta in May with its HCM drug mava­camten, as gen­er­al coun­sel and cor­po­rate sec­re­tary. She re­places the re­tir­ing Cyn­thia Ladd, who had been with the South San Fran­cis­co bio­phar­ma since Jan­u­ary 2018. Wayn­ick was pre­vi­ous­ly UCB’s US gen­er­al coun­sel & head of glob­al en­ter­prise risk man­age­ment.

→ Back in ear­ly April, we not­ed the pro­mo­tion of Jesse Mc­Cool to CEO of Ok­la­homa City-based CD­MO Cy­to­vance Bi­o­log­ics. This week, they’ve en­list­ed Yuk Chun Chiu as VP of man­u­fac­tur­ing op­er­a­tions. Chiu has been as­so­ci­at­ed with some of the biggest names in the in­dus­try: Be­fore mov­ing on to Cy­to­vance, he was As­traZeneca’s di­rec­tor of man­u­fac­tur­ing and en­gi­neer­ing, and he’s al­so been group head of process an­a­lyt­i­cal tech­nol­o­gy at Bay­er.

Nor­bert Bischof­berg­er’s bio­phar­ma Kro­nos Bio, fo­cused on mod­u­lat­ing tran­scrip­tion fac­tors in can­cer, has re­cruit­ed Jen­nifer Nichol­son as VP, reg­u­la­to­ry af­fairs. Nichol­son had been with Ac­er­ta (ac­quired by As­traZeneca) as their head of reg­u­la­to­ry, specif­i­cal­ly the glob­al reg­u­la­to­ry lead for Calquence. She kicked off her reg­u­la­to­ry ca­reer at Genen­tech, where she re­mained for 11 years, even­tu­al­ly mov­ing on to roles at Jazz Phar­ma­ceu­ti­cals and Onyx Phar­ma­ceu­ti­cals.

Stephen Squin­to

→ San An­to­nio-based bioAffin­i­ty Tech­nolo­gies has named Alex­ion co-founder Stephen Squin­to vice chair­man of their board of di­rec­tors, and the can­cer di­ag­nos­tics and ther­a­peu­tics com­pa­ny al­so tapped David Elzi as VP of re­search. Squin­to is cur­rent­ly an ex­ec­u­tive part­ner with Or­biMed Health­care Fund Man­age­ment, while Elzi joined bioAffin­i­ty in 2016 as their di­rec­tor of ba­sic re­search.

→ Say­ing he wants to chan­nel his en­er­gy in­to his work at Cel­lec­tis, An­dré Chouli­ka is re­tir­ing from the board of di­rec­tors at Ca­lyxt (for­mer­ly Cel­lec­tis Plant Sci­ences). At the same time, the board named Lau­rent Arthaud as a Cel­lec­tis des­ig­nat­ed di­rec­tor. Chouli­ka co-found­ed and had chaired Ca­lyxt since 2010.

Ed­win Moses

Ed­win Moses, who as­sumed the chair­man­ship of Achilles Ther­a­peu­tics in De­cem­ber 2018, will be chair­man of the board at French hear­ing loss-fo­cused bio­phar­ma Sen­so­ri­on, suc­ceed­ing Patrick Lan­glois. Cur­rent­ly the chair­man of 2 oth­er com­pa­nies, Avan­tium and Lab­Ge­nius, Moses was the long­time CEO of Abl­ynx.

Au­dentes Ther­a­peu­tics EVP and chief op­er­at­ing of­fi­cer Thomas Soloway has hopped on the board of di­rec­tors at mi­graine-fo­cused South San Fran­cis­co biotech Sat­suma Phar­ma­ceu­ti­cals. Soloway is for­mer­ly the SVP and CFO of As­cendis Phar­ma A/S and the EVP and COO of Tran­scept Phar­ma­ceu­ti­cals.

Michael Shep­ard, one of the 3 in­ven­tors of Her­ceptin, has signed on to the board of di­rec­tors at Pa­cif­ic North­west biotech Pas­cal Bio­sciences. Shep­ard start­ed his ca­reer in 1980 at Genen­tech and has al­so been VP and CSO at Halozyme Ther­a­peu­tics.

→ Af­ter hav­ing their NASH drug elafi­bra­nor fail in a Phase III to dis­tin­guish it­self from place­bo, Gen­fit has wel­comed for­mer J&J ex­ec Kather­ine Kalin and Eli Lil­ly vet Er­ic Ba­clet to its board of di­rec­tors.

→ Ex-Cel­gene ex­ec George Golumbes­ki has joined the board of di­rec­tors at Nor­wood, MA-based biotech Cor­bus Phar­ma­ceu­ti­cals. In ad­di­tion to his time at Cel­gene, Golumbes­ki held roles at No­var­tis, Elan Phar­ma­ceu­ti­cals and Schwarz Phar­ma.

Lorenz Mayr

→ Up­start cell con­ver­sion biotech Mo­gri­fy has made the ad­di­tion of Lorenz Mayr to its board of di­rec­tors. Most re­cent­ly, Mayr served as chief tech­ni­cal of­fi­cer at GE Health­care Life Sci­ences and has had stints at As­traZeneca and No­var­tis.

→ South San Fran­cis­co cell ther­a­py play­er Al­lo­gene has added Thomas Gajew­s­ki and Stephan Grupp to their sci­en­tif­ic ad­vi­so­ry board. Gajew­s­ki is the Ab­b­Vie Foun­da­tion Pro­fes­sor in Can­cer Im­munother­a­py at the Uni­ver­si­ty of Chica­go, while Grupp is the di­rec­tor of the Can­cer Im­munother­a­py Pro­gram, di­rec­tor of trans­la­tion­al re­search for the Cen­ter for Child­hood Can­cer Re­search and med­ical di­rec­tor of the Stem Cell Lab­o­ra­to­ry at Chil­dren’s Hos­pi­tal of Philadel­phia.

→ Col­lab­o­rat­ing with Janssen Phar­ma­ceu­ti­cals to pro­pel its be.well plat­form for­ward, Alveo Tech­nolo­gies has cho­sen Justin Steb­bing for their sci­en­tif­ic ad­vi­so­ry board, join­ing fel­low mem­bers George Church, John DeVin­cen­zo and Poo­ja Goel. Steb­bing is a pro­fes­sor of can­cer med­i­cine and on­col­o­gy and con­sul­tant on­col­o­gist at Im­pe­r­i­al Col­lege Lon­don.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

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Am­gen sev­ers 14-year Cy­to­ki­net­ics part­ner­ship, bail­ing on ome­cam­tiv af­ter mixed PhI­II re­sults

Amgen is shrugging off a 14-year development alliance and the tens of millions of dollars spent to develop a new heart drug at Cytokinetics after a Phase III trial turned up weak data — leaving Cytokinetics to soldier on alone.

Omecamtiv mecarbil technically worked, meeting the primary composite endpoint in the Phase III GALACTIC-HF study. But it missed a key secondary endpoint, which analysts had been following as a key marker for success — reduction of cardiovascular (CV) death. While Cytokinetics celebrated the results, its stock tanked 43% upon the news, and analysts warned of an uncertain path ahead. Now, Amgen wants out.