Centes­sa gives An­toine Yver a new role, brings his old col­league on board; Pre­lude to a change: Jane Huang sets up her next move

An­toine Yver

Centes­sa looked to Dai­ichi Sankyo to fill the CMO post with An­toine Yver back in May 2021, and now that Yver has gar­nered a new ti­tle, why mess with a good thing?

Yver has been in­stalled as chair­man of de­vel­op­ment, and Centes­sa is go­ing back to the En­her­tu well again by ap­point­ing Javad Shahi­di as CMO. While Yver was head of on­col­o­gy R&D at Dai­ichi Sankyo, Shahi­di was the glob­al team leader for En­her­tu at the As­traZeneca part­ner. “I look for­ward to work­ing with Javad again as we con­tin­ue to grow Centes­sa with this in­cred­i­ble port­fo­lio of as­sets and come clos­er to bring­ing im­pact­ful new med­i­cines to pa­tients,” Yver said in a state­ment.

Shahi­di al­so led clin­i­cal de­vel­op­ment of Al­im­ta and Por­traz­za dur­ing a three-year run at Eli Lil­ly.

Jane Huang

End­points News dis­cussed Jane Huang’s res­ig­na­tion as CMO of hema­tol­ogy at BeiGene last week, and her des­ti­na­tion has been con­firmed: Start­ing April 4, Huang will be pres­i­dent and CMO of Wilm­ing­ton, DE-based Pre­lude Ther­a­peu­tics, the Or­biMed-backed can­cer biotech whose shares have tak­en a nose-dive since its Sep­tem­ber 2020 Nas­daq de­but in the midst of the IPO-palooza. Huang, one of our Women in Bio­phar­ma R&D hon­orees for 2021, worked on such rec­og­niz­able drugs as Rit­ux­an, Avastin and Kad­cy­la at Genen­tech be­fore spend­ing a year with Ac­er­ta Phar­ma as head of clin­i­cal de­vel­op­ment and lat­er join­ing BeiGene in 2016.

J&J has named Wendy Suss­man head of phar­ma­ceu­ti­cals for US fed­er­al af­fairs, who piv­ots to the phar­ma gi­ant af­ter four years at EMD Serono as VP & head, US health­care gov­ern­ment & pub­lic af­fairs. Suss­man, the ex-VP of pub­lic af­fairs for No­var­tis’ gener­ics crew at San­doz, will al­so be pri­ma­ry li­ai­son to PhRMA. Last week J&J notched a win with reg­u­la­tors for its BC­MA CAR-T along­side its part­ners at Leg­end, and a win in the court­room in­volv­ing its “Texas two-step” bank­rupt­cy case.

→ Part­ner­ing with Ei­sai on drug dis­cov­ery for such dis­eases as Parkin­son’s and de­men­tia with Lewy bod­ies — and chaired by Ra­dius Health’s top dog Kel­ly Mar­tin — UK-based neu­ro biotech Wren Ther­a­peu­tics has tapped Bart Hen­der­son as CEO. The founder and ex-pres­i­dent of Rhythm Phar­ma­ceu­ti­cals and Mo­tus Ther­a­peu­tics, Hen­der­son’s al­so been chief ex­ec­u­tive at what’s now known as Reper­toire Im­mune Med­i­cines from 2017-19. Af­ter Reper­toire’s name change from Torque, Hen­der­son was an op­er­at­ing part­ner at Flag­ship Pi­o­neer­ing.

Gi­na Con­syl­man

→ Ac­cord­ing to a Form 8-K, Gi­na Con­syl­man is on her way out as blue­bird bio’s CFO ef­fec­tive April 2, while CBO Ja­son Cole is set to re­place her. Once the belle of the gene ther­a­py ball, blue­bird’s mount­ing fi­nan­cial quandary is such that it “raise[s] sub­stan­tial doubt re­gard­ing its abil­i­ty to con­tin­ue as a go­ing con­cern,” which doesn’t seem to square with CEO An­drew Oben­shain’s de­c­la­ra­tion of 2022 as a “land­mark year” in the same re­lease. For that to hap­pen, blue­bird needs to quit shoot­ing it­self in the foot with PDU­FA de­lays and clin­i­cal holds in ad­di­tion to find­ing a rem­e­dy to the cash prob­lems. Con­syl­man had on­ly been CFO since last Au­gust and came to blue­bird af­ter serv­ing as fi­nance chief of Iron­wood Phar­ma­ceu­ti­cals.

Al San­drock

→ The Maraganore Me­ter is back in work­ing or­der as ex-Al­ny­lam chief John Maraganore be­comes strate­gic ad­vi­sor to the su­per­vi­so­ry board at Pro­QR, a start­up that need­ed some good news af­ter its lead as­set se­po­farsen bel­lyflopped in a Phase II/III tri­al for Leber con­gen­i­tal amau­ro­sis last month.

Mean­while, Al San­drock has yet to catch up with Maraganore in the ap­point­ment de­part­ment, but he can prob­a­bly hold his own as he joins the board of di­rec­tors at Ata­lan­ta Ther­a­peu­tics, the neu­ro-fo­cused siR­NA biotech part­ner­ing with Genen­tech and San­drock’s old com­pa­ny, Bio­gen. This fur­ther adds to the op­por­tu­ni­ties that have opened up for San­drock af­ter his de­par­ture as Bio­gen’s R&D chief, in­clud­ing board seats at Voy­ager and Verge Ge­nomics.

Jonathan Javitt

Jonathan Javitt has re­tired as CEO of NRx (short­ened from Neu­roRx) but he won’t wan­der off too far, tak­ing on a con­sul­tan­cy gig as “chief sci­en­tist.” “Dr. Javitt will re­main on the Board of Di­rec­tors,” the re­lease states, “but will no longer be re­spon­si­ble for com­pa­ny op­er­a­tions or day-to-day man­age­ment.” Head of op­er­a­tions and chief com­mer­cial of­fi­cer Robert Besthof, a long­time Pfiz­er vet, takes on the role of in­ter­im CEO as NRx wages a court bat­tle with Re­lief Ther­a­peu­tics over the Covid-19 drug they part­nered on, avip­tadil.

Serge Messer­lian

Serge Messer­lian has left Big Phar­ma be­hind to lead a com­pa­ny of his own, grab­bing the CEO job at GPCR up­start Teon Ther­a­peu­tics out of San Fran­cis­co. Messer­lian — the ex-pres­i­dent of Acte­lion and a 17-year vet of Bax­ter and Bax­al­ta — breaks away from J&J’s Janssen, where he was pres­i­dent of the US on­col­o­gy unit. He re­places co-founder and act­ing chief ex­ec­u­tive Lina Yao as she slides in­to the role of CSO. Messer­lian talked to End­points ear­li­er this week about the “fan­tas­tic op­por­tu­ni­ty to join the team and help cat­alyze the ef­fort there.”

Sid­dhartha Ka­dia

Berke­ley Lights start­ed the year off by re­as­sign­ing CEO Er­ic Hobbs, who’s of­fi­cial­ly the pres­i­dent of an­ti­body ther­a­peu­tics now that the dig­i­tal cell bi­ol­o­gy out­fit has lined up Sid­dhartha Ka­dia as the next chief ex­ec­u­tive. A board mem­ber at Berke­ley Lights since Sep­tem­ber, Ka­dia was pres­i­dent and CEO of EAG Lab­o­ra­to­ries from 2014-18 and al­so has board seats at Iso­Plex­is and Nu­Va­sive, among oth­ers. Berke­ley Lights will al­so be search­ing for a new CFO, as Kurt Wood an­nounces his de­par­ture “to pur­sue his ex­pressed in­ter­est in a role out­side of the biotech in­dus­try” ef­fec­tive April 1.

Lynne Mur­ray

Miro­Bio, the Ox­ford spin­out helmed by first-year CEO and No­var­tis alum Car­olin Barth, has in­stalled San­jay Keswani as CMO and pro­mot­ed Lynne Mur­ray to CSO. Keswani, the ex-Roche SVP and glob­al head of neu­ro­science, oph­thal­mol­o­gy and rare dis­eases re­search and ear­ly de­vel­op­ment, and the for­mer VP, ex­plorato­ry and clin­i­cal trans­la­tion­al re­search with Bris­tol My­ers Squibb, had been CMO for An­nex­on Bio­sciences since June 2019. Mur­ray joined Miro­Bio in Oc­to­ber 2020 as SVP of R&D af­ter she was head of re­gen­er­a­tion at As­traZeneca’s ear­ly res­pi­ra­to­ry & im­munol­o­gy de­part­ment.

William Shen

Or­na Ther­a­peu­tics, the apt­ly named MPM-seed­ed start­up de­vel­op­ing cir­cu­lar RNA (oR­NA) pro­grams, has wel­comed William Shen as CBO. Shen, the for­mer head of M&A and in­ter­im head of cor­po­rate de­vel­op­ment at Bio­gen, had re­cent­ly been COO of Vir­tu­oso Ther­a­peu­tics for a brief pe­ri­od and was an M&A lead dur­ing his five years at Bris­tol My­ers, which jumped on the Or­na band­wag­on with such big names as NI­BR, Kite and Astel­las for the com­pa­ny’s Se­ries A in Feb­ru­ary 2021. Else­where at Or­na, ex-No­var­tis Phar­ma­ceu­ti­cals CEO Thomas Ebel­ing has been added to the board of di­rec­tors.

Soo­jin Kim

In­ozyme, the de­vel­op­er of en­zyme re­place­ment ther­a­pies from the IPO Class of 2020, has added two mem­bers to its ex­ec­u­tive team: San­jay Sub­ra­man­ian has tak­en over as CFO, and Soo­jin Kim has been ap­point­ed SVP and chief tech­ni­cal op­er­a­tions of­fi­cer, a po­si­tion for­mer­ly held by Steven Jun­gles, who has an­nounced his re­tire­ment. Pri­or to join­ing In­ozyme, Sub­ra­man­ian served as CFO and head of cor­po­rate de­vel­op­ment at Ocu­gen. Kim most re­cent­ly served as SVP and site head of the bio plant com­plex at Han­mi Phar­ma­ceu­ti­cal.

→ One of Jen­nifer Doud­na’s CRISPR star­tups, Alame­da, CA-based Scribe Ther­a­peu­tics, has cor­ralled David Par­rot as CFO and George Man­ning as con­troller. Par­rot hails from Bar­clays, where he was a man­ag­ing di­rec­tor and head of West Coast life Sci­ence in­vest­ment bank­ing. Pre­vi­ous­ly at Al­lo­gene, Man­ning was se­nior di­rec­tor and as­sis­tant con­troller be­fore turn­ing the page at Scribe, which was al­so co-found­ed by Ben­jamin Oakes, Brett Staahl and David Sav­ageand racked up $100 mil­lion in a Se­ries B last March. Con­cur­rent with the raise, Be­hzad Ag­haz­adeh from Avoro and Carl Gor­don of Or­biMed be­came mem­bers of Scribe’s board of di­rec­tors.

Robert Ho

Launched last month with ex-Au­dentes chief Na­tal­ie Holles at the con­trols and rak­ing in a new nine-fig­ure round of fund­ing to push its lead can­di­dates for chron­ic ur­ticaria in­to the clin­ic, Third Har­mon­ic Bio has se­lect­ed Robert Ho as CFO. The Mor­gan Stan­ley vet had held the same post at Ne­oleukin Ther­a­peu­tics the past two years and he’s al­so been se­nior fi­nance di­rec­tor for DaVi­ta.

Su­san Cata­lano

→ Gene ther­a­py de­vel­op­er Co­da Bio­ther­a­peu­tics, Mike Narachi’s lat­est project af­ter sell­ing Orex­i­gen that fo­cus­es on neu­ro con­di­tions like neu­ro­path­ic pain and epilep­sy, has ap­point­ed Su­san Cata­lano as CSO. Cata­lano co-found­ed Cog­ni­tion Ther­a­peu­tics in 2007 and was chief sci­en­tist for the Alzheimer’s biotech, which land­ed on Nas­daq in Oc­to­ber 2021 with a noth­ing-fan­cy IPO. Pri­or to Cog­ni­tion, the Roche and Rigel alum was di­rec­tor of dis­cov­ery bi­ol­o­gy at Acu­men Phar­ma­ceu­ti­cals. A cadre of in­vestors led by Paci­ra Bio­Sciences put up $28 mil­lion of fi­nanc­ing in De­cem­ber as Co­da made Paci­ra CEO David Stack a mem­ber of the board of di­rec­tors.

Aaron Tward

→ Hear­ing gene ther­a­py com­pa­ny Ak­ou­os is bring­ing in Aaron Tward as CSO. Tward joined the Boston-based com­pa­ny in 2018 as part of its sci­en­tif­ic ad­vi­so­ry board. Tward served as an as­so­ciate pro­fes­sor of oto­laryn­gol­o­gy — head and neck surgery at UCSF and pre­vi­ous­ly had a 6-year stint at the Broad In­sti­tute.

Re­neo Phar­ma­ceu­ti­cals rolled on­to Nas­daq in April 2021 be­fore a bear mar­ket squelched the de­sire for more com­pa­nies to do the same, and this week the mi­to­chon­dr­i­al dis­ease biotech has pro­mot­ed Michael Cruse to COO and Jen­nifer Lam to prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer. Cruse, the for­mer SVP of cor­po­rate op­er­a­tions at Re­neo since De­cem­ber 2020, has held se­nior po­si­tions be­fore at Avanir Phar­ma­ceu­ti­cals and Ele­don Phar­ma­ceu­ti­cals (back when it was Ot­ic Phar­ma and then Novus Ther­a­peu­tics). Lam just be­came VP of fi­nance and ac­count­ing at Re­neo six months ago af­ter her posts at Am­plyx, where she was con­troller and then VP of fi­nance at the com­pa­ny Pfiz­er bought last April.

Monique Bobadil­la

Monique Bobadil­la has signed on to be chief peo­ple and cul­ture of­fi­cer with Chris Var­ma-led Fron­tier Med­i­cines, the South San Fran­cis­co up­start striv­ing for the next big thing in KRAS af­ter the ap­proval of Am­gen’s Lumakras. Be­fore set­ting off for Fron­tier — which net­ted $88.5 mil­lion for those KRAS am­bi­tions with a Se­ries B last Ju­ly — Bobadil­la held the same ti­tle at En­cod­ed and al­so spent more than a decade in hu­man re­sources at Genen­tech.

→ Cell ther­a­py start­up Clade Ther­a­peu­tics has poached Derek Hei from Ver­tex, nam­ing him chief tech­nol­o­gy of­fi­cer. For the last year, Hei had been Ver­tex’s SVP of pre­clin­i­cal and clin­i­cal man­u­fac­tur­ing, cell and gene ther­a­pies, and from 2017-21 he was a man­u­fac­tur­ing ex­ec at Blue­Rock Ther­a­peu­tics. Clade, es­tab­lished by Sana and CRISPR Ther­a­peu­tics co-founder Chad Cow­an, en­tered the iP­SC fray with a $87 mil­lion Se­ries A back in No­vem­ber.

Marie McAvoy

→ UK-based biotech NanoSy­rinx, which touts it­self as “the first com­pa­ny to en­gi­neer pro­tein ‘nanosy­ringes’ as a cell-se­lec­tive non-vi­ral pep­tide and pro­tein de­liv­ery sys­tem,” has brought on Marie McAvoy as CSO. Pri­or to join­ing NanoSy­rinx, McAvoy was se­nior di­rec­tor of the on­col­o­gy cell ther­a­py re­search unit as Glax­o­SmithK­line. She has al­so served as GSK’s di­rec­tor, head trans­la­tion­al re­search, cell and gene ther­a­py.

Scott Say­well

Cerev­el schiz­o­phre­nia part­ner Herophilus has re­cruit­ed Scott Say­well as CBO. Say­well be­gan his tenure at Ther­a­vance Bio­phar­ma in 2015 as se­nior di­rec­tor, busi­ness de­vel­op­ment, get­ting el­e­vat­ed to VP, cor­po­rate de­vel­op­ment and strat­e­gy in 2019 be­fore head­ing to Herophilus, a San Fran­cis­co biotech that al­so no­tably hired CSO Sharath Hegde from Re­cur­sion and head of chem­istry Brad Savall from Plex­i­um.

AVM Biotech­nol­o­gy is lock­ing in Bri­an An­der­sen as CCO and Pearl Chan as CFO. An­der­sen joins with ex­pe­ri­ence from his times at Vi­dara Ther­a­peu­tics (co-founder), Phar­ma­cia, Den­dreon and Hori­zon Ther­a­peu­tics un­der his belt, while Chan has served as CFO at Pic­Mon­key and Net­Mo­tion Soft­ware among oth­ers.

Is­abelle Lefeb­vre

→ Wa­ter­town, MA-based Eye­point Phar­ma­ceu­ti­cals has ap­point­ed Is­abelle Lefeb­vre as chief reg­u­la­to­ry of­fi­cer, tak­ing over the po­si­tion from John Weet, who had been SVP, reg­u­la­to­ry since Au­gust 2018. Most re­cent­ly, Lefeb­vre was VP, head of reg­u­la­to­ry sci­ence at Hen­grui USA, and she’s al­so held se­nior reg­u­la­to­ry po­si­tions at Lund­beck, Bausch Health Com­pa­nies and Bris­tol My­ers.

Gau­rav Shah’s team at Rock­et Phar­ma­ceu­ti­cals is go for launch with Jessie Ye­ung as VP of in­vestor re­la­tions and cor­po­rate fi­nance. Ye­ung was head of cor­po­rate fi­nance and in­vestor re­la­tions for Leg­end, and she al­so brings fi­nan­cial ex­pe­ri­ence from JP Mor­gan and Bank of Amer­i­ca Mer­rill Lynch. The Phase I tri­al for Rock­et’s drug RP-A501, a gene ther­a­py for Danon dis­ease, is in full swing again af­ter the FDA lift­ed a clin­i­cal hold in Au­gust 2021.

Bill Ringo

→ Can­cer out­fit Sen­sei Bio­ther­a­peu­tics has tapped Bill Ringo as chair­man of the board. Ringo, who al­so chairs the board for John McHutchi­son at As­sem­bly Bio­sciences, is a 30-year Eli Lil­ly vet who was Pfiz­er’s SVP of strat­e­gy and busi­ness de­vel­op­ment from 2008-10. Not in­clud­ed in the re­lease is the ar­rival of SVP of can­cer im­munol­o­gy Hanspeter Wald­ner, who’s held se­nior im­munol­o­gy lead­er­ship roles at Blue­Rock Ther­a­peu­tics and CRISPR Ther­a­peu­tics.

→ Not long af­ter Har­lan Wak­sal as­sumed the role of chair­man, Lyra Ther­a­peu­tics has made room for one-time Bio­gen CEO Jim To­bin on the board of di­rec­tors. To­bin be­came CEO of Boston Sci­en­tif­ic for 10 years af­ter his stint as Bio­gen chief from 1997-99.

Di­ana Brainard

Di­ana Brainard has made her way to the board of di­rec­tors at Affinia, the sec­ond move in­volv­ing the AAV gene ther­a­py com­pa­ny in as many weeks af­ter co-founder Robert John­son be­came CEO of Adres­tia. Brainard, the for­mer vi­rol­o­gy chief at Gilead, has been CEO at AlloVir for al­most a full year.

→ San Diego-based Jan­u­ary Ther­a­peu­tics has signed on Christo­pher LeMas­ters to its board of di­rec­tors. LeMas­ters just fin­ished a stint as COO of Am­plyx, where he helped lead the afore­men­tioned sale of the com­pa­ny and its lead an­ti­fun­gal to Pfiz­er. Pri­or to that, LeMas­ters was EVP and CBO of Mi­rati Ther­a­peu­tics.

Corinne Le Goff

→ Ex-Mod­er­na chief com­mer­cial of­fi­cer Corinne Le Goff is say­ing yes to a board ap­point­ment as in­de­pen­dent di­rec­tor at Paris-based Ac­ti­cor Biotech. Le Goff has quite a few stints un­der her belt in­clud­ing roles at Aven­tis, Pfiz­er, Mer­ck, Roche and Am­gen.

Arti­va Bio­ther­a­peu­tics, which ex­e­cut­ed the 1-2 punch of a CAR-NK pact with Mer­ck and a nine-fig­ure Se­ries B with­in weeks of each oth­er in ear­ly 2021, has added Lau­ra Bessen to the board of di­rec­tors. Bessen was head of US med­ical to cap off a 15-year tenure at Bris­tol My­ers.

David Smith

→ For­mer Five Prime CFO David Smith has been tacked on to the board of di­rec­tors at Dan­ish IDO/PD-L1 can­cer vac­cine play­er IO Biotech, which hit Nas­daq last fall. Five Prime and its an­ti-FGFR2b an­ti­body be­mar­ituzum­ab were sold to Am­gen right around this time last year for $2 bil­lion.

→ A month af­ter Bernard Lam­bert took the chief tech­nol­o­gy of­fi­cer job at Curie Ther­a­peu­tics, the ra­dio­phar­ma play­er has elect­ed Karen Smith to the board of di­rec­tors. Smith is a Big Phar­ma vet from Bris­tol My­ers and As­traZeneca as well as the ex-CMO and glob­al head of R&D at Jazz Phar­ma­ceu­ti­cals.

→ Hous­ton-based Mol­e­culin Biotech is tack­ing on Joy Yan to its board of di­rec­tors. This isn’t Yan’s first board ap­point­ment, as she cur­rent­ly serves as in­de­pen­dent board di­rec­tor at Check­mate Phar­ma­ceu­ti­cals. Yan brings with her ex­pe­ri­ence from her times at Am­brx (CMO and mem­ber of the SAB), Bris­tol My­ers, Janssen and Bay­er.

Keno­ta Health is adding two new faces to its board of di­rec­tors with the ap­point­ments of Ruth Ab­dul­mas­sih and Den­nis Flan­nel­ly. Ab­dul­mas­sih is the CEO of Al­ter­na­tive Bio­med­ical So­lu­tions, while Flan­nel­ly is the head of pre­ci­sion med­i­cine for US on­col­o­gy at Mer­ck. Pri­or to his cur­rent role at Mer­ck, Flan­nel­ly was VP and gen­er­al man­ag­er of im­mun­odi­ag­nos­tics at PerkinElmer and glob­al head of mar­ket­ing for Ther­mo Fish­er Sci­en­tif­ic’s im­mun­odi­ag­nos­tics busi­ness.

Nan­cy Beesley

HCB Health pres­i­dent Nan­cy Beesley has pulled up a chair at the board of di­rec­tors of Der­ma­vant, the tap­inarof mak­er try­ing to stand out in the plaque pso­ri­a­sis mar­ket. Beesley joined HCB Health near­ly 20 years ago as chief com­mer­cial of­fi­cer and was named pres­i­dent in 2019.

Juhyun Lim has made her way to the board of di­rec­tors at Spec­trum Phar­ma­ceu­ti­cals, a com­pa­ny that elim­i­nat­ed a third of its work­force to start 2022 and will see its CFO Kurt Gustafson walk out the door. Lim is the pres­i­dent, glob­al strat­e­gy and plan­ning for Han­mi Sci­ence and Han­mi Phar­ma­ceu­ti­cal.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

BREAK­ING: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Ivan Cheung, Eisai US chairman and CEO

Bio­gen, Ei­sai re­fresh amy­loid hy­poth­e­sis with PhI­II show­ing Alzheimer's med slows cog­ni­tive de­cline

In the first look at Phase III data for lecanemab, Eisai and Biogen’s follow-up Alzheimer’s drug to the embattled Aduhelm launch, results show the drug passed with flying colors on a test looking at memory, problem solving and other dementia metrics.

One of the most-watched Alzheimer’s therapies in the clinic, lecanemab met the study’s primary goal on the CDR-SB — Clinical Dementia Rating-Sum of Boxes — giving the biotech the confidence to ask for full approval in the US, EU and Japan by next March 31. The experimental drug reduced clinical decline on the scale by 27% compared to placebo at 18 months, the companies said Tuesday night Eastern time and Wednesday morning in Japan.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Vlad Coric, Biohaven CEO (Photo Credit: Andrew Venditti)

As Amy­lyx de­ci­sion waits in the wings, Bio­haven’s ALS drug sinks (again) in plat­form tri­al

The FDA’s decision on Amylyx’s ALS drug is set to come out sometime Thursday. In a space with few drugs, any approval would be a major landmark.

But elsewhere in the ALS field, things are a bit more tepid.

Thursday morning, Biohaven announced that its drug verdiperstat failed its arm of an ALS platform trial led by Massachusetts General Hospital. According to a press release, the drug did not meet its primary endpoint — improvement on an ALS functional status test — or any key secondary endpoints at 24 weeks. The trial had enrolled 167 patients, giving them either verdiperstat or placebo twice a day.

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Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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Marcelo Bigal, Ventus Therapeutics CEO

No­vo Nordisk joins No­var­tis, Roche in NL­RP3 are­na, bet­ting $70M cash on NASH, car­diometa­bol­ic us­es

As a drug target, the NLRP3 inflammasome has drawn serious interest from Big Pharma, inspiring a series of M&A deals from Novartis and Roche on top of venture investments by others. Now Novo Nordisk is jumping on the bandwagon — and the Danish pharma giant is taking the target where it knows best.

Novo Nordisk is getting its NLRP3 inhibitors from Ventus Therapeutics, a Versant-backed startup that set out to make some of the best NLRP3 drugs out there by incorporating new insights into the structure of the target complex.

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