NASH hope­ful Gen­fit pro­motes Dean Hum to pres­i­dent; Im­mune Ther­a­peu­tics CEO pass­es ba­ton to suc­ces­sor

In 1999, while Dean Hum was an as­so­ciate pro­fes­sor at Laval Uni­ver­si­ty in Que­bec, Gen­fit reached out to him. An ex­pert in the mod­u­la­tion of tran­scrip­tion fac­tors and nu­clear re­cep­tors as­so­ci­at­ed with en­docrine and car­diometa­bol­ic dis­eases, Hum jumped aboard the com­pa­ny as CSO and has been with them ever since, cur­rent­ly serv­ing as the com­pa­ny’s COO.

Dean Hum Gen­fit

He has now been ap­point­ed as pres­i­dent of GEN­FIT Corp, GEN­FIT’s sub­sidiary in the US — but will still re­tain his du­ties as COO — and will be mov­ing from the com­pa­ny’s head­quar­ters in Lille, France to Gen­fit’s US-based of­fice near Boston.

“What this move means is that we’re re­al­ly push­ing for­ward to build­ing our pres­ence in the Unit­ed States and car­ry­ing over the lead­er­ship pres­ence we have here in Lille to the tal­ent­ed pool of peo­ple at the Boston group and build­ing up and man­ag­ing that team,” he told End­points News. 

The com­pa­ny is now fo­cus­ing its at­ten­tion on NASH and the up­com­ing Phase III read­out of elafi­bra­nor —  which was award­ed or­phan drug sta­tus, months ago, by US and EU reg­u­la­tors to treat pa­tients with pri­ma­ry bil­iary cholan­gi­tis (PBC) — that is ex­pect­ed in Q1 of 2020.

In ad­di­tion, Suneil Hos­mane has been pro­mot­ed to head of glob­al di­ag­nos­tics af­ter serv­ing as ex­ec­u­tive vice pres­i­dent of strate­gic de­vel­op­ment.

Suneil Hos­mane

In his new role, Hos­mane will man­age the de­vel­op­ment and mar­ket­ing ac­tiv­i­ties re­lat­ed to NIS4 — the com­pa­ny’s pro­pri­etary blood test de­signed to iden­ti­fy NASH pa­tients el­i­gi­ble for treat­ment.

These tran­si­tions come af­ter Gen­fit CEO Jean-François Mouney an­nounced that he was pass­ing the reigns down to his cho­sen suc­ces­sor, Pas­cal Pri­gent, whilst re­main­ing Chair­man of the Board of Di­rec­tors.



Im­mune Ther­a­peu­tics — a T-Cell ac­ti­va­tion bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on the treat­ment of au­toim­mune and in­flam­ma­to­ry con­di­tions, can­cer, HIV/AIDS and an­i­mal dis­eases — has tapped Michael Han­d­ley to head the com­pa­ny as CEO and a mem­ber of the board of di­rec­tors. Han­d­ley will suc­ceed Noreen Grif­fin, who is re­sign­ing. Han­d­ley is the cur­rent CEO and chair­man at can­cer-fo­cused Aletheia Ther­a­peu­tics. He draws ex­pe­ri­ence from his pre­vi­ous ex­ec po­si­tions, in­clud­ing CEO and di­rec­tor of Armis Bio­phar­ma, vice pres­i­dent of qual­i­ty, clin­i­cal and reg­u­la­to­ry af­fairs at Ves­six Vas­cu­lar (ac­quired by Boston Sci­en­tif­ic) and chief com­pli­ance of­fi­cer and vice pres­i­dent of glob­al reg­u­la­to­ry af­fairs at The Spec­tra­net­ics (ac­quired by Phillips). Han­d­ley has al­so held stints at J&J, Am­gen and Genen­tech — where he helped in the launch of Avastin and Tarce­va

→ New York-based Neu­ro­gene — tack­ling rare neu­ro­log­i­cal con­di­tions with a pipeline of gene ther­a­pies us­ing AAV tech — has wel­comed Chris­tine Mikail aboard as the com­pa­ny’s pres­i­dent. Mikail draws from ex­pe­ri­ence as co-founder of Neu­men­tum and Fer­n­dale Ad­vi­sors. She was the chief ad­min­is­tra­tive of­fi­cer and head of ex­ter­nal busi­ness de­vel­op­ment/al­liance man­age­ment & gen­er­al coun­sel at Ax­o­vant Sci­ences, where she helped the team raise $362 mil­lion for the com­pa­ny’s IPO. In ad­di­tion to those, she has held stints at NPS Phar­ma­ceu­ti­cals, Den­dreon, Eli Lil­ly and Im­Clone Sys­tems.

For­ma Ther­a­peu­tics has made some new ad­di­tions to its lead­er­ship team with the ap­point­ments of for­mer Syn­log­ic CFO Todd She­gog as SVP, CFO and Take­da vet Jean­nette Potts as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary. At the same time, the com­pa­ny re­cent­ly pro­mot­ed Patrick Kel­ly to SVP, CMO and Mary Wadlinger to SVP, cor­po­rate af­fairs and chief hu­man re­sources of­fi­cer. In ad­di­tion, the com­pa­ny al­so ap­point­ed for­mer Boston Con­sult­ing Group prin­ci­pal Scott Boyle as vice pres­i­dent, busi­ness and cor­po­rate de­vel­op­ment and Genen­tech vet Bri­an Less­er as vice pres­i­dent, ther­a­peu­tic head. 

Joshua Brumm, COO and CFO of Kalei­do Bio­sciences — fo­cused on the mi­cro­bio­me or­gan to treat dis­ease — is hit­ting the ex­it to serve as pres­i­dent and CEO of an un­named “biotech­nol­o­gy com­pa­ny.” The com­pa­ny has ini­ti­at­ed the search for a new CFO, and in the mean­time, Richard Scal­zo, the com­pa­ny’s cor­po­rate con­troller, has been ap­point­ed to serve as prin­ci­pal ac­count­ing of­fi­cer and will tem­porar­i­ly as­sume Brumm’s re­spon­si­bil­i­ties. 

Francesco Gal­i­mi

Adicet Bio — fo­cused on the de­vel­op­ment of al­lo­gene­ic cell ther­a­pies for can­cer us­ing gam­ma delta T cells — has en­list­ed Francesco Gal­i­mi as SVP and CMO. Gal­i­mi makes the shift to the com­pa­ny from Am­gen, where he served as glob­al pro­gram gen­er­al man­ag­er, ear­ly de­vel­op­ment. Pri­or to his time at Am­gen, Gal­i­mi was the head of clin­i­cal de­vel­op­ment at Onyx Phar­ma­ceu­ti­cals and served at GNF/No­var­tis.

→ James Wil­son’s gene ther­a­py start­up, Pas­sage Bio — which re­cent­ly scored $110 mil­lion in a Se­ries B fi­nanc­ing led by bil­lion­aire Len Blavat­nik’s con­glom­er­ate — has wel­comed Gary Ro­mano as CMO and Edgar (Chip) Cale as gen­er­al coun­sel. Ro­mano joins the com­pa­ny af­ter a stint as the head of clin­i­cal de­vel­op­ment for neu­rode­gen­er­a­tive dis­ease and the deputy leader of the neu­rode­gen­er­a­tive dis­ease ther­a­peu­tic area at Janssen. Pri­or to that, he held po­si­tions at Mer­ck Re­search Lab­o­ra­to­ries in the de­part­ments of clin­i­cal neu­ro­science and ex­per­i­men­tal med­i­cine. Cale jumps aboard af­ter a stint as SVP of le­gal cor­po­rate func­tions at GSK and gen­er­al coun­sel of GSK’s vac­cine unit. Pri­or to his time at GSK, Cale was a cor­po­rate and se­cu­ri­ties lawyer at Ven­ture Law Group and Brobeck, Phleger & Har­ri­son

→ Ge­nomics-dri­ven re­search and di­ag­nos­tics com­pa­ny, MedGenome, ap­point­ed An­drew Pe­ter­son as the com­pa­ny’s CSO. Pri­or to his ap­point­ment, Pe­ter­son was the se­nior di­rec­tor of mol­e­c­u­lar bi­ol­o­gy at Genen­tech, fo­cused on the ge­nom­ic ap­pli­ca­tions for ther­a­peu­tics in ar­eas such as car­dio­vas­cu­lar dis­eases and liv­er dis­eases. Pe­ter­son is al­so cred­it­ed with lead­ing the sci­en­tif­ic ef­forts of a con­sor­tium that, as part of the GenomeA­sia 100k con­sor­tium. pro­duced a com­pre­hen­sive cat­a­log of ge­net­ic vari­a­tion in more than 35,000 genomes across Asia.

OnKure has named James Win­kler as vice pres­i­dent of dis­cov­ery and trans­la­tion­al bi­ol­o­gy, R. Michael Car­ruthers as CFO and Kei­th Olivia as gen­er­al coun­sel and vice pres­i­dent of cor­po­rate af­fairs. Win­kler brings ex­pe­ri­ence to this new role from po­si­tions he has served at FOR­MA Ther­a­peu­tics, Arv­inas, Ar­ray Bio­Phar­ma, GSK, SmithK­line Beecham and J&J. Car­ruthers draws from his pre­vi­ous ex­pe­ri­ence as CFO at Ni­valis, Ar­ray Bio­Phar­ma and Siev­ers In­stru­ments. Olivia hops aboard the com­pa­ny af­ter serv­ing as OnKure’s out­side cor­po­rate coun­sel since its found­ing in April 2011. 

Joseph Perekup­ka Brain­sway

Pa­lo Al­to Health Sci­ences — whose prod­uct, Frees­pi­ra, is the on­ly FDA-cleared dig­i­tal ther­a­peu­tic for treat­ing pan­ic at­tacks, pan­ic re­lat­ed dis­or­ders and PTSD — has an­nounced the ad­di­tion of Joseph Perekup­ka as CCO. Most re­cent­ly, Perekup­ka served as the SVP of North Amer­i­ca at Brain­sway, where he helped with the com­ple­tion of the com­pa­ny’s US IPO ear­li­er this year. Pre­vi­ous­ly, Perekup­ka served in po­si­tions at St Jude Med­ical and Biotron­ik.

EMD Serono — the US bio­phar­ma busi­ness for Mer­ck KGaA — has tapped Kirk Tay­lor as se­nior vice pres­i­dent, North Amer­i­can med­ical af­fairs. Pri­or to join­ing the com­pa­ny, Tay­lor was the se­nior vice pres­i­dent, med­ical af­fairs strat­e­gy and op­er­a­tions for Ve­rastem On­col­o­gy. In ad­di­tion, he has served as chief of strat­e­gy and late phase de­vel­op­ment as well as CMO for Finch Ther­a­peu­tics Group.

Beam Ther­a­peu­tics — which was launched by CRISPR trail­blaz­ers and Ed­i­tas’ sci­en­tif­ic founders David Liu, Feng Zhang, and J Kei­th Jounghas en­list­ed Bri­an Ri­ley as the com­pa­ny’s se­nior vice pres­i­dent of tech­ni­cal op­er­a­tions. Pri­or to jump­ing aboard to Beam, Ri­ley led the bi­o­log­ics busi­ness of Catal­ent Phar­ma So­lu­tions. His pre­vi­ous stints in­clude roles at bio­Merieux, Bio­gen, Am­gen and Diosynth Biotech­nol­o­gy

Fang Wang Fog­Phar­ma

Gre­go­ry Ver­dine, founder of Fog­Phar­ma, has made two new ad­di­tions to its team. The com­pa­ny wel­comed Fang Wang as vice pres­i­dent of bi­ol­o­gy and Nan­cy Wilk­er as vice pres­i­dent and lead IP coun­sel. Wang joins the com­pa­ny af­ter a decade at Agios Phar­ma­ceu­ti­cals, where she was di­rec­tor of bi­ol­o­gy and cham­pi­oned the rare ge­net­ic dis­ease “type II D-2HG aciduria” pro­gram. She al­so led the de­vel­op­ment of the an­ti-mu­tant EGFRT790M an­ti­body at Aveo Phar­ma­ceu­ti­cals and helped de­vel­op the an­ti-ERBB3 an­ti­body that was part­nered with Bio­gen. Wilk­er hails from Bio­gen, where she held the po­si­tion of IP coun­sel. Pri­or to her time at Bio­gen, Wilk­er served as IP coun­sel at CSL com­pa­ny Se­qirus, was a part­ner at Sun­stein Kann Mur­phy and Tim­bers and held stints at Cell Sig­nal­ing Tech­nol­o­gy, PerkinElmer, Wilmer Cut­ler Pick­er­ing Hale and Dorr and Clark and El­bing

Nan­cy Wilk­er Fog­Phar­ma

Mi­crosoft is try­ing to make a big­ger push to­wards health­care — ink­ing an al­liance with Adap­tive Biotech­nolo­gies to de­vel­op a blood test that can help with the ear­ly de­tec­tion of dis­ease. Mak­ing fur­ther strides to­wards that goal, it was an­nounced that the com­pa­ny had nom­i­nat­ed GSK CEO Em­ma Walm­s­ley to its board of di­rec­tors. In ad­di­tion, the com­pa­ny an­nounced that two of the com­pa­ny’s board mem­bers, Charles Nos­ki, for­mer vice chair­man of AT&T and Bank of Amer­i­ca and Hel­mut Panke, for­mer chair­man of the board of man­age­ment at BMW AG, have de­cid­ed not to seek re-elec­tion to the board. 

Kally­ope CEO Nan­cy Thorn­ber­ry has hopped on­to the board of di­rec­tors at Schrödinger, which re­ceived $110 mil­lion in its first ven­ture round back in May. Thorn­ber­ry will be join­ing GV en­tre­pre­neur-in-res­i­dence Rosana Kapeller on the board, who en­tered in Jan­u­ary

Em­ma Walm­s­ley GSK

William “Bill’’ Alis­ki is join­ing the board of di­rec­tors of X4 Phar­ma­ceu­ti­cals — which back in May teamed up to col­lab­o­rate with the Leukemia & Lym­phoma So­ci­ety to ac­cel­er­ate the de­vel­op­ment of their lead prod­uct can­di­date, ma­vorix­afor, for the treat­ment of Waldern­ström’s macroglob­u­line­mia. Alis­ki brings ex­pe­ri­ence to the role from his time as CCO of Fol­dRX Phar­ma­ceu­ti­cals and as gen­er­al man­ag­er for Bio­marin Eu­rope

→ Sero­tonin 2A re­cep­tor ag­o­nists (or psy­che­delics)-fo­cused Eleu­sis — which re­cent­ly fund­ed a mice study that found that (R)-DOI could be used to treat car­dio­vas­cu­lar dis­ease and po­ten­tial­ly curb di­a­betes — has ap­point­ed David Guy­er to its board of di­rec­tors. Cur­rent­ly, Guy­er serves as the ex­ec­u­tive chair­man of IVER­IC bio and has had stints as CEO of Eye­tech Phar­ma­ceu­ti­cals (lat­er ac­quired by OSI Phar­ma­ceu­ti­cals) and as a part­ner at VC firm SV Life Sci­ences Ad­vis­ers

Nan­cy Thorn­ber­ry Kally­ope

Qrons — a com­pa­ny fo­cused on the de­vel­op­ment of stem cell-syn­thet­ic hy­dro­gel-based so­lu­tions for the treat­ment of trau­mat­ic brain in­juries, like con­cus­sions and pen­e­trat­ing in­juries — has brought on for­mer NFL de­fen­sive line­man Der­rick Cham­bers to the com­pa­ny’s ad­vi­so­ry board. The com­pa­ny’s CEO, Jon­ah Meer, not­ed that Cham­bers will make a great ad­di­tion to the team due to his aware­ness of the “po­ten­tial for Chron­ic Trau­mat­ic En­cephalopa­thy, a pro­gres­sive de­gen­er­a­tive dis­ease of the brain that re­sults from repet­i­tive con­cus­sions and is of­ten found in long­time play­ers of the sport.”

→ A few months af­ter hav­ing their shares dent­ed be­cause of un­der­whelm­ing Phase III HAE da­ta — they failed to cut the at­tack rate by at least 50% — BioCryst has wel­comed He­len Thack­ray to the com­pa­ny’s board of di­rec­tors. Thack­ray is the CMO and se­nior vice pres­i­dent of clin­i­cal de­vel­op­ment at Gly­coMimet­ics — which re­cent­ly had its own woes af­ter Pfiz­er dis­missed their lead drug as a Phase III fail­ure. 

He­len Thack­ray Gly­coMimet­ics

Escient Phar­ma­ceu­ti­cals — fo­cused on ad­vanc­ing G pro­tein cou­ple re­cep­tor (GCPR)-tar­get­ed drugs — has wel­comed co-founder and for­mer CEO of Plexxikon (lat­er ac­quired by Dai­ichi Sankyo in 2011) K. Pe­ter Hirth to the com­pa­ny’s board of di­rec­tors. Pri­or to his stint at Plexxikon — where two of their drugs, Zelb­o­raf and Tu­ralio, re­ceived FDA ap­proval — Hirth served at Sug­en and Boehringer Mannheim.

Fen­nec Phar­ma­ceu­ti­cals — fo­cused on the de­vel­op­ment of PED­MARK (sodi­um thio­sul­fate) for the pre­ven­tion of plat­inum-in­duced oto­tox­i­c­i­ty in pe­di­atric pa­tients — has ap­point­ed Jo­di Cook to the com­pa­ny’s board of di­rec­tors. Cook cur­rent­ly serves as head of gene ther­a­py strat­e­gy at PTC Ther­a­peu­tics. Her pri­or ex­pe­ri­ence spans roles in­clud­ing the COO of Ag­ilis Bio­ther­a­peu­tics and as di­rec­tor of the hear­ing aid pro­gram at Mayo Clin­ic

Paula Soteropou­los Akcea

→ UK-based ear­ly can­cer de­tec­tion com­pa­ny Oncim­mune Hold­ings has wel­comed Tariq Sethi as CSO, Matthew Lut­trell as CMO and Cléa Rosen­feld as head of in­vestor re­la­tions. Sethi is a pro­fes­sor of res­pi­ra­to­ry med­i­cine at King’s Col­lege Lon­don. Be­fore jump­ing on board at Oncim­mune, Sethi was chief physi­cian-sci­en­tist, vice pres­i­dent in the clin­i­cal dis­cov­ery unit at As­traZeneca. He is al­so the founder of Galec­to Biotech. Lut­trell joins the com­pa­ny af­ter a stint as head of hema­tol­ogy, growth and emerg­ing mar­kets at Shire (now Take­da). He’s served in oth­er roles at Eli Lil­ly, No­vo Nordisk, Gilead, and GSK. Rosen­feld brings ex­pe­ri­ence to her new role from her time as head of in­vestor re­la­tions at Shire, where she helped bring the com­pa­ny from an FTSE 250 Com­pa­ny to a top 50 FTSE com­pa­ny.

→ The top 3 ex­ecs run­ning Io­n­is’ ma­jor­i­ty-owned spin­off Akcea are hit­ting the ex­it in a sur­prise twist Mon­day morn­ing. Akcea $AK­CA re­port­ed that CEO Paula Soteropou­los, Pres­i­dent Sarah Boyce and COO Jef­frey Gold­berg are out in a clean sweep. The board has placed Damien McDe­vitt — the chief busi­ness of­fi­cer on the moth­er ship — in the in­ter­im chief ex­ec­u­tive spot as they hunt for some per­ma­nent re­place­ments. Michael J. Yang and Joseph ‘Skip’ Klein III, mean­while have joined the com­pa­ny’s board of di­rec­tors. Mod­er­na vet Soteropou­los and Gold­berg will now switch out to ad­vi­so­ry roles to “help en­sure a smooth tran­si­tion.” 

Bri­an A. Johns HIV Cure Cen­ter

Bri­an A. Johns, a top HIV sci­en­tist at GSK’s Vi­iV, is fol­low­ing the well-trav­eled road in­to biotech, af­ter a 20-year stint as VP in charge of ex­ter­nal dis­cov­ery sci­ences. Not­ed as a co-in­ven­tor of do­lute­gravir — a best­selling HIV drug mar­ket­ed alone as Tivicay — as well as the long-act­ing cabote­gravir, Johns was fea­tured in PhRMA’s Go Bold­ly cam­paign cel­e­brat­ing the in­dus­try’s break­through suc­cess­es and the peo­ple who made them hap­pen. And now he’s join­ing He­mo­S­hear in Char­lottesville, VA as their new CSO. In a state­ment, Johns said he was par­tic­u­lar­ly ex­cit­ed to be fo­cus­ing on rare pe­di­atric meta­bol­ic dis­eases. A cou­ple of years ago He­mo­S­hear al­so lined up a $470 mil­lion col­lab­o­ra­tion with Take­da on NASH, an­oth­er big in­di­ca­tion that has at­tract­ed a slew of com­peti­tors look­ing to make their mark.

→ Uni­ver­si­ty of Basel, Switzer­land spin­out T3 Phar­ma­ceu­ti­cals wel­comed aboard Claire Bar­ton as CMO af­ter hav­ing been with the com­pa­ny as a con­sul­tant for the past 18 months. Her pre­vi­ous stints in­clude roles at Glax­oW­ell­come, Lil­ly and Roche. This comes at the same time that the com­pa­ny raised 12 mil­lion CHF at the close of its sec­ond fi­nanc­ing round, which will help pro­pel the can­cer-fo­cused com­pa­ny’s lead prod­uct, T3P-Y058-739, in­to clin­i­cal test­ing, ex­pect­ed to be­gin in the mid­dle of 2020.

In­for­ma­tion added for clar­i­fi­ca­tion re­gard­ing Gen­fit

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 7 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff.

KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Samit Hirawat. Bristol-Myers Squibb

Bris­tol-My­ers is mak­ing a bee-line to the FDA with pos­i­tive liso-cel da­ta — but is it too late in the CAR-T game?

Bristol-Myers Squibb came to ASH this past weekend with a variety of messages on the new cancer drugs they had acquired in the big Celgene buyout, including liso-cel, the lead CAR-T program picked up in the $9 billion Juno acquisition. And one of the most important was that they had the pivotal efficacy and safety data needed to snag an approval from the FDA next year, with the BLA on track for a filing this month.

J&J team shows off 'break­through' BC­MA CAR-T da­ta, and that could cause a big headache at blue­bird and Bris­tol-My­ers

Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off of the multiple myeloma data for JNJ-4528 that impressed the FDA. And it’s easy to see why they may well be on a short path to a landmark approval — which may well be making the rival team at bluebird/Bristol-Myers more than a little nervous.

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Jake Van Naarden, Josh Bilenker, Nisha Nanda (Credit: Loxo, Aisling Capital)

Josh Bilenker and his Loxo crew are tak­ing the reins on on­col­o­gy R&D at Eli Lil­ly, culling the weak and map­ping a new path

Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory.

So what are they doing?

They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a top-15 industry player. They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pipeline, highlighting their star prospects and going after new programs wherever they can find the best prospects.

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