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

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Daphne Zohar (PureTech)

PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.