Lab­Corp se­lects its new CEO; Pfiz­er names ex-Genen­tech vet as new head of on­col­o­gy R&D

Adam Schechter The Org

→ Long­time Mer­ck ex­ec­u­tive Adam Schechter will be tak­ing over as CEO and pres­i­dent of Lab­Corp with the re­tire­ment of David King on Oc­to­ber 31— when he will be­come ex­ec­u­tive chair­man of the board of di­rec­tors. The com­pa­ny says that “the board ex­pects to choose one of its mem­bers to be lead in­de­pen­dent di­rec­tor at a lat­er date.”

Schechter has been on Lab­Corp’s board since April 1, 2013, serv­ing as the lead in­de­pen­dent di­rec­tor since Jan­u­ary of this year. Dur­ing his long-time stint at Mer­ck, Schechter helped lead the in­te­gra­tion of Mer­ck and Scher­ing-Plough and held ex­ec­u­tive roles in the com­pa­ny, in­clud­ing pres­i­dent of glob­al hu­man health and pres­i­dent of Mer­ck’s glob­al phar­ma­ceu­ti­cal busi­ness.

Pa­tri­cia Hurter Busi­ness Wire

King has served as CEO for 13 years, start­ing in Jan­u­ary 1, 2007. Pri­or to his ap­point­ment to CEO at Lab­Corp, King was ex­ec­u­tive vice pres­i­dent, COO and ex­ec­u­tive vice pres­i­dent of strate­gic plan­ning and cor­po­rate de­vel­op­ment. When King first joined the com­pa­ny in 2001 — he pre­vi­ous­ly served as the prin­ci­pal out­side le­gal coun­sel for sev­er­al years to the com­pa­ny — he served as SVP, gen­er­al coun­sel and chief com­pli­ance of­fi­cer.

Pa­tri­cia Hurter will be at the helm of Lyn­dra Ther­a­peu­tics — which is work­ing on an “ul­tra-long-act­ing oral de­liv­ery sys­tem” — as its CEO ef­fec­tive Sep­tem­ber 3, 2019. Hurter will be suc­ceed­ing co-founder Amy Schul­man, a VC who is be­com­ing ex­ec­u­tive chair. Pri­or to join­ing Lyn­dra, Hurter had a stint at Ver­tex as the com­pa­ny’s se­nior vice pres­i­dent of phar­ma­ceu­ti­cal and pre­clin­i­cal sci­ences and in­ter­im head of glob­al reg­u­la­to­ry af­fairs.

Leif Jo­hans­son As­traZeneca

On­co­Cyte Cor­po­ra­tion — a de­vel­op­er of non-in­va­sive tests for the ear­ly de­tec­tion of lung can­cer — an­nounced that Ronald An­drews will take charge of the com­pa­ny as its CEO, ef­fec­tive Ju­ly 1. On­co­Cyte’s cur­rent CEO, William An­nett, will re­main with the com­pa­ny in an ad­vi­so­ry role dur­ing the tran­si­tion.

With over 30 years in the field, An­drews has had var­i­ous stints, in­clud­ing CEO and founder of Bethes­da Group, CEO of Clar­i­ent (for­mer­ly Chro­maV­i­sion Med­ical Sys­tems), CEO of GE Mol­e­c­u­lar Di­ag­nos­tics, ex­ec­u­tive roles at Roche Mol­e­c­u­lar Di­ag­nos­tics and he sits on the board of di­rec­tors for three com­pa­nies.

Jeff Set­tle­man Cal­i­co

Leif Jo­hans­son’s time as As­traZeneca chair­man is com­ing to an end as re­tire­ment looms. Jo­hans­son has had sev­en event­ful years with the com­pa­ny — sur­viv­ing a takeover bid by Pfiz­er, a turn­around mis­sion and some po­lit­i­cal tur­moil. Un­der FTSE-100 reg­u­la­tions, board mem­bers are not con­sid­ered “in­de­pen­dent” if they re­main in their po­si­tions be­yond nine years.

Jo­hans­son was re­cruit­ed to As­traZeneca’s board in 2012, af­ter stints at AB Elec­trolux and LM Er­ic­s­son. Soon af­ter join­ing the com­pa­ny, he brought on Pas­cal So­ri­ot from Roche to serve as the com­pa­ny’s chief. The two worked to­geth­er to help As­traZeneca bounce back from a raft of patent ex­pi­ra­tions and suc­cess­ful­ly fend­ed off Pfiz­er’s at­tempt to ex­e­cute a $118 bil­lion hos­tile takeover in 2014.

Scott Biller Agios

His pay to­taled £690,000 in 2018, mak­ing him one of the best-paid chairs of an FTSE-100 com­pa­ny ac­cord­ing to Sky News.

Pfiz­er scooped up Cal­i­co ex­ec Jeff Set­tle­man to head its on­col­o­gy R&D ops in La Jol­la. Set­tle­man steps in as the com­pa­ny pre­pares for the re­tire­ment of Robert Abra­ham — whose ex­pe­ri­ence stretch­es back to his ear­ly years at Wyeth.

Set­tle­man is now man­ag­ing 800 em­ploy­ees di­vid­ed be­tween tu­mor cell bi­ol­o­gy, can­cer im­munol­o­gy dis­cov­ery and tar­get ther­a­peu­tics, each with their own lead­ers.

Robert Ian­none Linkedin

Set­tle­man served as a Har­vard fac­ul­ty mem­ber for 18 years and his first en­try to the in­dus­try was in 2010 when he took up a dis­cov­ery po­si­tion at Genen­tech, which has seed­ed the Bay Area biotech hub with sea­soned tal­ent.

Pfiz­er’s on­col­o­gy unit has seen quite a bit of change in re­cent years. Just a few weeks ago, Dim­it­ry Nuyten, clin­i­cal head in im­muno-on­col­o­gy, jumped to Aduro. Charles Hugh-Jones left last Au­gust for Al­ler­gan af­ter a 16-month stint as CMO; on the com­mer­cial side, Liz Bar­rett was snatched up by No­var­tis be­fore mov­ing on to lead the biotech Uro­Gen.

John Oyler BeiGene

→ The CSO of Agios Phar­ma­ceu­ti­cals, Scott Biller, has an­nounced his re­tire­ment — af­ter be­ing with the com­pa­ny for near­ly a decade. Biller will re­tire at the end of 2019, but will con­tin­ue to serve as a strate­gic ad­vi­sor through the end of 2020. The com­pa­ny has ini­ti­at­ed a search for his suc­ces­sor.

→ Ear­li­er in April Rob Ian­none an­nounced that he was leav­ing his po­si­tion as CMO of Im­munomedics to head to Penn­syl­va­nia to be “close to his fam­i­ly.” Well, it looks like Jazz Phar­ma­ceu­ti­cals — a com­pa­ny sell­ing and de­vel­op­ing drugs for sleep dis­or­ders and can­cer — has snatched the for­mer As­traZeneca ex­ec to lead its glob­al R&D team. Pri­or to his stint at As­traZeneca, Ian­none worked for Mer­ck, where he helped de­vel­op its PD-1 in­hibitor star, Keytru­da.

Alex­is Borisy Third Rock Ven­tures

→ As Chi­na’s in­flu­ence on glob­al biotech con­tin­ues to grow, Beigene CEO and chair­man John Oyler, who co-found­ed the com­pa­ny in 2010, has been elect­ed to BIO’s board of di­rec­tors as well as the or­ga­ni­za­tion’s health sec­tion gov­ern­ing board.

→ Ahead of Third Rock’s record $770 mil­lion fund for its next wave of in­vest­ments in the life sci­ences field, one key in­vestor, Alex­is Borisy, made an un­ex­pect­ed ex­it from the com­pa­ny. Borisy, who head­ed up in­vest­ments in Ma­gen­ta, Rev­o­lu­tion, Blue­print and more, is head­ed for parts cur­rent­ly un­known. He was not in­volved in rais­ing the last round and won’t be han­dling the in­vest­ment deals.

Robert Pe­tit Ad­vax­is

Caris­ma Ther­a­peu­tics — a bio­phar­ma­ceu­ti­cal com­pa­ny fo­cus­ing on de­vel­op­ing cell ther­a­py plat­forms based on en­gi­neered macrophages — has wel­comed Robert Pe­tit as its CSO. Pe­tit joins the biotech af­ter his most re­cent stint as CSO of Ad­vax­is. Pe­tit has a wealth of ex­pe­ri­ence, co-found­ing an im­muno-on­col­o­gy pro­gram in the ear­ly days of cell ther­a­py, work­ing as a part of the pi­o­neer­ing team at BMS to es­tab­lish the first check­point in­hibitor ther­a­py, es­tab­lish­ing aca­d­e­m­ic IL-2 LAK and TIL cell treat­ment pro­grams — among oth­er things.

Samuel Zhang NeoIm­muneTech

NeoIm­muneTech (NIT) wel­comed Samuel Zhang to the com­pa­ny as its CBO. Zhang’s most re­cent stint was as VP, prod­uct and port­fo­lio strat­e­gy at Merus. Pri­or to that Zhang held po­si­tions at Eli Lil­ly, Pfiz­er, Bris­tol-My­ers Squibb and No­var­tis On­col­o­gy.

→ While its lead pro­gram ETH42 ad­vances to­ward clin­i­cal tri­als, Ethris — a com­pa­ny spe­cial­iz­ing in mR­NA ther­a­peu­tics, with specifics in pul­monary dis­ease — an­nounced the ap­point­ment of Thomas Lan­genick­el as CMO.  The No­var­tis vet was pre­vi­ous­ly the ex­ec­u­tive di­rec­tor and head of res­pi­ra­to­ry pro­fil­ing with­in the trans­la­tion­al med­i­cine group. Pri­or to No­var­tis AG, Lan­genick­el held po­si­tions in dis­cov­ery med­i­cine at Bris­tol-My­ers Squibb.

Thomas Lan­genick­el Ethris

Ned Sharp­less has named Kea­gan Leni­han as the FDA chief of staff, re­plac­ing Lau­ren Sil­vis — who is leav­ing the agency some­time this month af­ter join­ing in May 2017 as deputy cen­ter di­rec­tor for pol­i­cy at the FDA’s Cen­ter for de­vices and ra­di­o­log­i­cal health. Pri­or to join­ing the FDA in Jan­u­ary 2018 as as­so­ciate com­mis­sion­er for strate­gic ini­tia­tives and ex­ter­nal af­fairs, Leni­han served as se­nior coun­selor to then-HHS sec­re­tary Tom Price and se­nior leg­isla­tive as­sis­tant to Price while he rep­re­sent­ed Geor­gia in the House as well as leg­isla­tive di­rec­tor for rep­re­sen­ta­tive Pe­te Ses­sions (R-Texas).

Kea­gan Leni­han FDA

→ Chi­na and US-based can­cer com­pa­ny Zai Lab has wel­comed Va­le­ria Fan­tin as its first-ever CSO. She will be based in the com­pa­ny’s US head­quar­ters in San Fran­cis­co, lead­ing the com­pa­ny’s in­ter­nal drug dis­cov­ery ef­fort on a glob­al ba­sis. Pri­or to join­ing Zai Lab, Fan­tin served as CSO at Oric Phar­ma­ceu­ti­cals – where she helped dri­ve its GR an­tag­o­nist ORIC-101 to clin­ic. Pri­or to that Fan­tin has held stints at Pfiz­er, Agios and Mer­ck re­search lab­o­ra­to­ries. Saman­tha Du, Zai Lab’s founder and CEO said that Fan­tin’s over 20-year ex­pe­ri­ence in on­col­o­gy drug dis­cov­ery will help lead with the in­ter­nal dis­cov­ery pipeline — which has a goal to an­nounce one to two INDs per year start­ing in 2020.

Va­le­ria Fan­tin Linkedin

→ Over the last year, BIO has sep­a­rat­ed its pub­lic af­fairs func­tions in­to two new de­part­ments. The in­dus­try or­ga­ni­za­tion an­nounced that ef­fec­tive June 17, Rich Mas­ters will head one de­part­ment as EVP for pub­lic af­fairs. Mas­ters joins from pub­lic af­fairs firm Qorvis com­mu­ni­ca­tions. Last sum­mer, the com­pa­ny named Jeanne Hag­ger­ty as EVP for gov­ern­ment af­fairs and ex­ter­nal re­la­tions of the oth­er de­part­ment. In ad­di­tion, BIO has an­nounced the de­par­ture of Ken Li­saius, the cur­rent SVP for com­mu­ni­ca­tions, ef­fec­tive June 14.  

Rich Mas­ters Qorvis

Leo Phar­ma, who spe­cial­izes in der­ma­tol­ogy, an­nounced that its pres­i­dent and CEO, Gitte Aabo, will be step­ping down af­ter 27 years — 11 as CEO — with the com­pa­ny. Cather­ine Maz­za­c­co will suc­ceed Aabo, ef­fec­tive Au­gust 1. Pre­vi­ous­ly, Maz­za­c­co was the head of glob­al com­mer­cial op­er­a­tions at the bio­phar­ma di­vi­sion of the GE Health­care unit of Gen­er­al Elec­tric.

Cather­ine Maz­za­c­co Busi­ness Wire

Flu­idigm Cor­po­ra­tion an­nounced the ap­point­ment of its first-ever CSO, An­drew Quong, who joins from the Fred­er­ick Na­tion­al Lab­o­ra­to­ry for Can­cer Re­search — which is spon­sored by the Na­tion­al Can­cer In­sti­tute (NIC) — as its di­rec­tor of strate­gic sci­en­tif­ic ini­tia­tives and part­ner­ships. Pri­or to his time at Fred­er­ick Na­tion­al Lab­o­ra­to­ry, Quong served as a fac­ul­ty mem­ber in the De­part­ment of Can­cer Bi­ol­o­gy at Thomas Jef­fer­son Uni­ver­si­ty and the De­part­ment of On­col­o­gy at George­town Uni­ver­si­ty.

Ther­a­vance Ther­a­peu­tics — who J&J gam­bled $1 bil­lion last year in a part­ner­ship with the com­pa­ny in hopes of the next block­buster JAK for Crohn’s, ul­cer­a­tive col­i­tis — has brought on An­drew Hind­man as se­nior vice pres­i­dent and CFO of the com­pa­ny.

An­drew Quong Linkedin

Most re­cent­ly Hind­man served as CBO of Acor­da Ther­a­peu­tics, where he led the com­pa­ny’s ac­qui­si­tions Civ­i­tas Ther­a­peu­tics and Bi­otie Ther­a­pies. Be­fore that, Hind­man was CEO and mem­ber of the board of pri­vate­ly-held biotech­nol­o­gy, To­bi­ra Ther­a­peu­tics, which was ac­quired by Al­ler­gan in 2016. Hind­man has al­so held stints at Nodal­i­ty, Onyx Phar­ma­ceu­ti­cals and Gilead Sci­ences.

→  Ei­sai — the US sub­sidiary of Tokyo-based Ei­sai Co — an­nounced Patrick Coyle as vice pres­i­dent and CFO of the com­pa­ny. He will serve on the ex­ec­u­tive com­mit­tee. Coyle will be re­spon­si­ble for the fi­nan­cial op­er­a­tions of the com­pa­ny in the US and Cana­da. Pri­or to join­ing Ei­sai, Coyle was vice pres­i­dent, fi­nan­cial plan­ning and analy­sis at IN­SMED. In ad­di­tion, he’s had stints in the fi­nance de­part­ments of No­var­tis, Bay­er Health­Care Phar­ma­ceu­ti­cals, Sun Chem­i­cal and Com­put­er Hori­zons Cor­po­ra­tion.

An­drew Hind­man Linkedin

→  Stephen Kennedy joins gene-edit­ing biotech Case­bia Ther­a­peu­tics as its SVP, head of tech­ni­cal op­er­a­tions. With 30 years of ex­pe­ri­ence in the field un­der his belt, Kennedy will over­see the com­pa­ny’s re­la­tion­ships with CROs and CMOs and will di­rect all man­u­fac­tur­ing and sup­port sup­ply chain, qual­i­ty and reg­u­la­to­ry. He will al­so es­tab­lish the process de­vel­op­ment and man­u­fac­tur­ing strat­e­gy for new gene-edit­ing based prod­ucts, both ex vi­vo cell-based and in vi­vo ther­a­pies. Most re­cent­ly, Kennedy served as the COO for restora­tive cell ther­a­py com­pa­ny His­to­gen­ics Cor­po­ra­tion. He’s al­so had stints at Mas­co­ma Corp., The No­var­tis/MIT Cen­ter for Con­tin­u­ous Man­u­fac­tur­ing and Gen­zyme.

Patrick Coyle Cis­ton

→  Eiger Bio­Phar­ma­ceu­ti­cls ap­points Jey­sen Yo­g­a­rat­nam — who spe­cial­izes in He­pati­tis B and C — as vice pres­i­dent of glob­al HDV clin­i­cal de­vel­op­ment. At his re­cent stint as se­nior med­ical di­rec­tor at Janssen Bio­phar­ma, Yo­g­a­rat­nam led drug de­vel­op­ment of he­pati­tis B virus (HBV) cap­sid as­sem­bly mod­u­la­tors.

“Jey­sen’s back­ground and ex­pe­ri­ence in liv­er dis­ease and an­tivi­ral drug de­vel­op­ment align well with our cur­rent and fu­ture HDV pro­gram needs as we ad­vance Lon­a­farnib in the first-ever Phase III glob­al study for HDV and Pegin­ter­fer­on Lamb­da to­ward Phase III for HDV,” said David Cory, pres­i­dent and CEO of Eiger. In ad­di­tion to his time at Janssen, Yo­g­a­rat­nam has had stints at MIF­COR, Ver­tex – where he was the med­ical lead on the an­ti-HCV pro­tease in­hibitor, telapre­vir (In­civek) and Bris­tol-My­ers Squibb.

Stephen Kennedy Linkedin

→ Cel­lu­lar and im­mune ther­a­peu­tics com­pa­ny, Gami­da Cell, has strength­ened its man­age­ment team with the ad­di­tion of Tracey Lodie as CSO. Lodie will suc­ceed Tony Peled, who is tran­si­tion­ing to the new­ly cre­at­ed role of chief tech­nol­o­gy of­fi­cer at the com­pa­ny.

“We are de­light­ed to wel­come Tracey to Gami­da Cell. Her deep ex­pe­ri­ence in au­toim­mu­ni­ty and im­muno-on­col­o­gy re­search will be crit­i­cal as we con­tin­ue to de­vel­op GDA-201 an in­ves­ti­ga­tion­al, nat­ur­al killer cell-based im­munother­a­py in Phase I de­vel­op­ment with the po­ten­tial to treat hema­to­log­ic ma­lig­nan­cies and sol­id tu­mors,” said Ju­lian Adams, CEO of Gami­da Cell.

Jey­sen Yo­g­a­rat­nam Linkedin

Pri­or to join­ing Gami­da Cell, Lodie served as SVP, trans­la­tion­al im­munol­o­gy at Blue­Rock Ther­a­peu­tics and has had stints at Sy­ros Phar­ma­ceu­ti­cals and Sanofi-Gen­zyme.

Tracey Lodie Linkedin

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.