Cut­ting loose from Mer­ck, Mike Nal­ly is 'run­ning to­ward a great op­por­tu­ni­ty'; No­var­tis part­ner­ship in hand, BeiGene pro­motes Ju­lia Wang to CFO

When Mike Nal­ly was an un­der­grad at Mid­dle­bury Col­lege in Ver­mont, he thought in­vest­ment bank­ing and fi­nance was his “path to sal­va­tion.”

He grad­u­at­ed in 1998 with his bach­e­lor’s in eco­nom­ics, then took a job at Don­ald­son, Lufkin & Jen­rette, an in­vest­ment bank lat­er bought by Cred­it Su­isse. He was tasked with do­ing re­search and analy­sis in the life sci­ences in­dus­try, but what he found sur­prised him.

Mike Nal­ly

“That re­al­ly fu­eled a pas­sion for the sci­ence, a pas­sion for the abil­i­ty to pos­i­tive­ly im­pact hu­man­i­ty, but al­so this ori­en­ta­tion to­ward a sense of pur­pose with­in my work,” Nal­ly said.

He went on to Har­vard Uni­ver­si­ty for his MBA, then spent 18 years in the ranks at Mer­ck, end­ing up as chief mar­ket­ing of­fi­cer of the phar­ma’s Hu­man Health unit. And now, amid a C-suite shake­up, Nal­ly is once again pack­ing his bags for Cam­bridge, MA, where he’ll be­come Flag­ship Pi­o­neer­ing’s lat­est CEO-part­ner just miles from his al­ma mater.

“We’re ex­cit­ed to come back af­ter 18 years around the world,” he said. “It’s a place that’s near and dear to our hearts.”

Ken Fra­zier

Nal­ly is tak­ing the helm at Gen­er­ate Bio­med­i­cines, an up­start lever­ag­ing ma­chine learn­ing and com­pu­ta­tion­al pow­er to learn the rules by which amino acid se­quences en­code for pro­tein struc­ture and func­tion. By do­ing so, Nal­ly be­lieves the 50-per­son team can gen­er­ate pro­teins that have “nev­er been seen on the plan­et be­fore.”

“We think the ap­proach has ap­plic­a­bil­i­ty across a range of modal­i­ties, whether that be an­ti­bod­ies, pep­tides, cy­tokines, and then more far-out places like mir­ror pro­tein cell and gene ther­a­py,” Nal­ly said. “There’s a wide range of ap­plic­a­bil­i­ty, and giv­en the in sil­i­co na­ture of dis­cov­ery, it al­lows you to dis­cov­er these pro­teins at a pace which is un­prece­dent­ed rel­a­tive to any­thing I’ve seen with­in in­dus­try.”

Nal­ly’s big move comes as Mer­ck’s chief ex­ec­u­tive Ken Fra­zier pre­pares to step down, and R&D MVP Roger Perl­mut­ter has hand­ed the reins over to Dean Li. Nal­ly, for­mer head of Mer­ck’s vac­cines busi­ness, was re­port­ed­ly in the run­ning to re­place Fra­zier, but the com­pa­ny in­stead went with CFO Robert Davis, a four-year Mer­ck vet­er­an.

While Nal­ly wouldn’t con­firm whether he was in con­sid­er­a­tion for the top spot, he says Davis’ ap­point­ment had noth­ing to do with his de­ci­sion to leave Mer­ck.

“I’m tremen­dous­ly ex­cit­ed about the op­por­tu­ni­ty at Flag­ship and with Gen­er­ate,” he said. “My move was not in re­sponse to any­thing oth­er than, you know, run­ning to­ward a great op­por­tu­ni­ty.” — Nicole De­Feud­is


Ju­lia Wang

→ Al­ready part­ner­ing with No­var­tis on tislelizum­ab, BeiGene had its eye on Boston Im­mune Tech­nolo­gies and Ther­a­peu­tics’ TN­FR2 an­tag­o­nist an­ti­bod­ies, with the two par­ties ar­rang­ing a de­vel­op­ment deal in Feb­ru­ary. With these col­lab­o­ra­tions in place, BeiGene has pro­mot­ed Ju­lia Wang to CFO, suc­ceed­ing the re­tir­ing Howard Liang, ef­fec­tive June 30. Wang came on board last year as SVP, en­ter­prise op­ti­miza­tion and deputy CFO for John Oyler’s folks. In her last stop at Alex­ion, she was SVP, glob­al busi­ness fi­nance and cor­po­rate plan­ning, and she al­so brings fi­nan­cial ex­pe­ri­ence from J&J and Pep­si­Co.

→ Ger­man CD­MO Rentschler Bio­phar­ma SE has plucked up Mar­tin Kessler as CEO of its US sub­sidiary Rentschler Bio­phar­ma Inc. Kessler comes from McK­in­sey & Com­pa­ny, where he com­plet­ed a 7-year stint as as­so­ciate part­ner. In ad­di­tion to the ti­tle of CEO, Kessler has been named SVP trans­for­ma­tion of Rentschler Bio­phar­ma SE.

Bri­an Alexan­der

→ It on­ly took three years for Bri­an Alexan­der to rise to the top of Roche sub­sidiary Foun­da­tion Med­i­cine, suc­ceed­ing Cindy Perettie as CEO of the ge­nom­ic pro­fil­ing com­pa­ny this com­ing Tues­day. Perettie, who be­came CEO in ear­ly 2019, an­nounced in Jan­u­ary that she would piv­ot to Roche Di­ag­nos­tics and take com­mand of the mol­e­c­u­lar lab so­lu­tions busi­ness. A ra­di­a­tion on­col­o­gist at Dana-Far­ber and Brigham and Women’s Hos­pi­tal, Alexan­der first ar­rived on the scene at Foun­da­tion Med­i­cine as SVP of clin­i­cal de­vel­op­ment in 2018 and was pro­mot­ed to CMO less than a year lat­er.

Car­olyn Star­rett

→ In an­oth­er Roche con­nec­tion, Flat­iron Health — which is an in­de­pen­dent af­fil­i­ate of the Roche Group — will be chang­ing CEOs, with Car­olyn Star­rett tak­ing over for co-founder Nat Turn­er start­ing April 16. On the same date, Flat­iron’s oth­er co-founder Zach Wein­berg, who was a Google staffer along with Turn­er, will al­so move on. Star­rett has led the com­mu­ni­ty on­col­o­gy busi­ness and got her start at Flat­iron in 2016 as VP, cus­tomer ex­pe­ri­ence and op­er­a­tions. Flat­iron was sold to Roche for $1.9 bil­lion back in Feb­ru­ary 2018.

→ Mak­ing its sec­ond sub­stan­tial hire in­volv­ing an Ab­b­Vie vet in as many weeks, No­var­tis has wooed Javier Boix from Rick Gon­za­lez’s crew to be­come glob­al head of com­mu­ni­ca­tions. Boix start­ed out at Ab­b­Vie be­fore the Ab­bott split in 2009 as a cor­po­rate and in­ter­nal com­mu­ni­ca­tions man­ag­er, work­ing his way up the lad­der to even­tu­al­ly lead the phar­ma gi­ant’s US com­mu­ni­ca­tions. Last week, No­var­tis ap­point­ed ex-Ab­b­Vie deputy gen­er­al coun­sel Karen Hale as chief le­gal of­fi­cer.

Pat­ty Allen

Vi­vid­ion now has Jeff Hat­field at the con­trols and $135 mil­lion to work with from a Se­ries C that in­clud­ed back­ing from an All-Star team of in­vestors. The next step this week is mak­ing Pat­ty Allen the per­ma­nent CFO af­ter two months with the in­ter­im tag. Allen’s most re­cent CFO gig was with Zaf­gen, and she’s been VP of fi­nance at Al­ny­lam as well as di­rec­tor of fi­nance at Alk­er­mes. In oth­er Vi­vid­ion news, Bri­an Koh has been giv­en the nod to lead trans­la­tion­al sci­ences and clin­i­cal de­vel­op­ment. Koh brings ex­pe­ri­ence from Gilead and Kite in clin­i­cal R&D in hema­tol­ogy and on­col­o­gy.

Bo Shan

→ The Cel­gene con­nec­tions at An­ten­gene have been fur­ther re­in­forced by re­cruit­ing Kevin Lynch as CMO. Lynch was VP and head of clin­i­cal de­vel­op­ment and med­ical af­fairs in the Asia-Pa­cif­ic ter­ri­to­ry for the lat­ter part of his tenure at Cel­gene, which struck a li­cens­ing deal in 2017 and helped con­tribute to the Chi­nese can­cer biotech’s fi­nanc­ing be­fore Bris­tol My­ers Squibb bought out the com­pa­ny. Else­where at An­ten­gene, Bo Shan has been pro­mot­ed to CSO af­ter his turn as a cor­po­rate VP with dis­cov­ery, ear­ly de­vel­op­ment, and CMC. Pri­or to his ar­rival at An­ten­gene in 2018, Shan was VP in charge of CMC at As­cle­tis.

Rene Rus­so-helmed Xilio, which lined up a $95 Se­ries C in Feb­ru­ary for its an­ti-CT­LA-4 an­ti­body and IL-2 ag­o­nist, has hand­ed CFO du­ties to Sal­va­tore Giovine and made Chris Franken­field gen­er­al coun­sel. Giovine wraps up a 15-year run at J&J, with the last three as Janssen’s fi­nance di­rec­tor in US on­col­o­gy in charge of such drugs as Darza­lex and Im­bru­vi­ca. Franken­field comes to Xilio af­ter near­ly six years at Blue­print Med­i­cines which saw him move up to VP, cor­po­rate le­gal af­fairs.

Christo­pher Wright

Aa­van­tiBio CEO Bo Cum­bo has been grad­u­al­ly as­sem­bling his team with Dou­glas Swirsky and Ty How­ton hit­ting the scene as CFO and COO, re­spec­tive­ly, in the last month. CMO and Ver­tex vet Christo­pher Wright is the lat­est piece in the lead­er­ship puz­zle at Aa­van­tiBio. Wright was pre­vi­ous­ly a CMO with Iron­wood spin­out Cy­cle­ri­on and the chief de­vel­op­ment of­fi­cer at Iron­wood, both of which have fall­en on hard times. At the tail end of his sev­en-year run with Ver­tex, he served as SVP, glob­al med­i­cines de­vel­op­ment and af­fairs.

→ Not long af­ter get­ting the FDA’s seal of ap­proval for Kimyr­sa in acute bac­te­r­i­al skin and skin struc­ture in­fec­tions (AB­SS­SI), Melin­ta Ther­a­peu­tics has tapped John Har­low as chief com­mer­cial of­fi­cer. Har­low has been around the block in the 20 years lead­ing up to the Melin­ta nod; he’s jumped around to biotechs like No­var­tis, Sh­iono­gi and En­do Phar­ma­ceu­ti­cals in var­i­ous sales and mar­ket­ing po­si­tions be­fore fi­nal­ly get­ting his first C-suite break in 2019 as CCO of Bau­dax Bio.

William Kennedy

→ San Fran­cis­co-based Ex­ci­sion Bio­Ther­a­peu­tics, which launched in Feb­ru­ary with $60 mil­lion in to­tal fund­ing — our Ja­son Mast pro­filed the CRISPR work of co-founder and chief sci­en­tif­ic con­sul­tant Kamel Khalili at the time — is bring­ing William Kennedy in­to the fold as SVP of clin­i­cal de­vel­op­ment, start­ing to­day. Kennedy, a Big Phar­ma vet whose cred­its in­clude Janssen, Genen­tech and Mer­ck, comes to Ex­ci­sion from Cal­ci­lytix, where he was VP, de­vel­op­ment. Else­where, he was VP of clin­i­cal de­vel­op­ment at Au­dentes.

Gre­go­ry Chow

Gre­go­ry Chow is tak­ing on an­oth­er CFO chal­lenge by head­ing to chemo­pro­teomics biotech Fron­tier Med­i­cines, which signed a pro­tein degra­da­tion deal with Ab­b­Vie for $55 mil­lion up­front in ear­ly De­cem­ber. Be­fore get­ting the call to join Chris Var­ma’s squad, Chow was EVP and CFO at Ap­tose Bio­sciences and al­so spent time at Wed­bush as man­ag­ing di­rec­tor and di­rec­tor of pri­vate place­ments.

→ Em­bold­ened by pos­i­tive da­ta from two Phase III tri­als of rof­lu­mi­last cream that would make an NDA a pos­si­bil­i­ty lat­er this year, Ar­cutis has filled three po­si­tions with Scott Bur­rows (CFO), Corey Padovano (VP of sales) and Sean Brug­ger (ex­ec­u­tive di­rec­tor of field med­ical af­fairs). Tak­ing over as CFO from John Smither, whose re­tire­ment is ef­fec­tive to­day, Bur­rows has been Ar­cutis’ VP of fi­nance since 2019 and held nu­mer­ous fi­nan­cial posts at Am­gen for 15 years be­fore a year with Shire lead­ing in­ter­na­tion­al in­vestor re­la­tions. Padovano had served at Gilead since 2013 and was the remde­sivir mak­er’s ex­ec­u­tive di­rec­tor, mar­ket­ing op­er­a­tions be­fore his new Ar­cutis gig. Brug­ger, an Am­gen vet in his own right, comes off al­most five years at Alex­ion and was re­cent­ly re­gion­al di­rec­tor of the meta­bol­ic dis­or­ders port­fo­lio.

Abi­gail Jenk­ins

→ Try­ing to put a lid on dai­ly pills, Wa­ter­town, MA-based Lyn­dra Ther­a­peu­tics has named Abi­gail Jenk­ins chief com­mer­cial and busi­ness of­fi­cer and Jacque­line Fer­nan­des VP of da­ta com­pli­ance and in­for­ma­tion tech­nol­o­gy. Jenk­ins be­gan her ca­reer at Pfiz­er in sales and mar­ket­ing, and her most re­cent post was with Emer­gent BioSo­lu­tions as SVP and busi­ness unit head of vac­cines. A 13-year Sunovion vet, Fer­nan­des is the lat­est to jump ship from Sarep­ta, where she served as se­nior di­rec­tor of da­ta com­pli­ance and chief pri­va­cy of­fi­cer.

→ Lon­don eye dis­ease biotech OKYO Phar­ma has called up­on Ra­jku­mar Patil to be CSO. For the last year, Patil had been VP of R&D with Ora (Oph­thalmic Re­search As­so­ci­ates). While he was with Al­con and lat­er the No­var­tis In­sti­tute of Bio­med­ical Re­search, Patil took on such roles as as­so­ciate di­rec­tor of re­search and head of mol­e­c­u­lar phar­ma­col­o­gy glau­co­ma and reti­na re­search.

Den­nis Giesing

→ Penn­syl­va­nia biotech Im­munome, which scored a De­part­ment of De­fense con­tract to de­vel­op biosyn­thet­ic con­va­les­cent plas­ma, has en­list­ed Den­nis Giesing as chief de­vel­op­ment of­fi­cer. Pri­or to Im­munome, Giesing was the long­time CSO at Taris Bio­med­ical un­til J&J bought the com­pa­ny in late 2019, at which point he tran­si­tioned to J&J’s on­col­o­gy team.

Mon­tis Bio­sciences has re­cruit­ed René Hoet as CSO. Hoet most re­cent­ly served as CSO at Im­check Ther­a­peu­tics and was pre­vi­ous­ly VP bi­o­log­ics re­search at Bay­er for 8 years. Pri­or to that, he was at Gen­mab.

→ Dig­i­tal health com­pa­ny Genome Med­ical has brought on Mar­co Bar­cel­la as chief prod­uct of­fi­cer and Bran­don Poe as CFO. Bar­cel­la most re­cent­ly served at Tia­tros and IBM Wat­son Health. Mean­while, Poe comes from Il­lu­mi­na, where he served as VP of fi­nance.

Clau­dia Nar­di­ni

En­thera Phar­ma­ceu­ti­cals has ap­point­ed Clau­dia Nar­di­ni as VP of re­search and de­vel­op­ment. Nar­di­ni had been head of glob­al pu­rifi­ca­tion & virus clear­ance prod­uct man­age­ment at Sar­to­rius Ste­d­im Biotech GmbH, and be­fore that she served at Bay­er and Kedri­on Bio­phar­ma.

Janux Ther­a­peu­tics, the small biotech that Mer­ck inked a $1 bil­lion deal with — has named Charles Win­ter as SVP of chem­istry, man­u­fac­tur­ing, and con­trols. Win­ter brings to the ta­ble a wealth of ex­pe­ri­ence from com­pa­nies like Gilead, De­nali, Anap­tys­Bio and Syn­thorx (now a Sanofi com­pa­ny). Win­ter launched his ca­reer at Genen­tech, where he spent 17 years.

Evonetix has ap­point­ed Michael Daniels as head of prod­uct man­age­ment. Daniels brings ex­pe­ri­ence from his times at Ar­cis Biotech­nol­o­gy, Can­cer Re­search UK, Ther­mo Fish­er and GE Health­care Life Sci­ences.

Mace Rothen­berg

Mace Rothen­berg’s post-Pfiz­er plans con­tin­ue to evolve by tak­ing on an­oth­er board ap­point­ment, this time with Au­los Bio­science, a biotech con­cen­trat­ing on (IL-2)-bind­ing mon­o­clon­al an­ti­bod­ies that Michael Ehlers co-found­ed. Just a week ago, the ex-Pfiz­er CMO joined the board of di­rec­tors at Tan­go Ther­a­peu­tics.

Michael Var­ney has now made his way to the ad­vi­so­ry board of Phoenix Mol­e­c­u­lar De­signs, which fo­cus­es on RSK ki­nase in­hibitors to fight triple neg­a­tive breast can­cer. Life af­ter re­tire­ment at Genen­tech has been kind to Var­ney, who is cur­rent­ly chair­man of R&D at Eras­ca and is al­so a se­nior ad­vi­sor at Fra­zier Health­care Part­ners.

Julie Ham­ble­ton

→ Ex-Bris­tol My­ers Squibb and Five Prime ex­ec Julie Ham­ble­ton has se­cured a spot on the board of di­rec­tors at Jonathan Lim-led can­cer biotech Eras­ca, along with Bi­hua Chen. Ham­ble­ton, who was al­so in clin­i­cal de­vel­op­ment at Genen­tech, is Arch On­col­o­gy’s in­ter­im pres­i­dent and CEO. Chen, who co-found­ed Cor­morant As­set Man­age­ment, fol­lowed the SPAC herd last Oc­to­ber with He­lix Ac­qui­si­tion.

→ With the FDA sign­ing off last month on Kro­nos Bio’s Phase III tri­al of en­tosple­tinib — one of the drugs Nor­bert Bischof­berg­er plucked from Gilead — the biotech has made Taiyin Yang a mem­ber of the board of di­rec­tors. Yang is a 28-year Gilead vet who is cur­rent­ly EVP of phar­ma­ceu­ti­cal de­vel­op­ment and man­u­fac­tur­ing for Dan O’Day’s crew.

Nagesh Ma­han­thap­pa

→ De­but­ing in De­cem­ber with a $25 mil­lion round based on work from Har­vard’s David Liu and Alan Saghatelian, Exo Ther­a­peu­tics has elect­ed Nagesh Ma­han­thap­pa to the board of di­rec­tors. Ma­han­thap­pa, who found­ed and helmed Schol­ar Rock, is al­so a board mem­ber at Cas­ma Ther­a­peu­tics. Exo has al­so named Charles Roberts from St. Jude Chil­dren’s Re­search Hos­pi­tal to the sci­en­tif­ic ad­vi­so­ry board.

PYC Ther­a­peu­tics has se­lect­ed Ja­son Had­dock to be a part of its board of di­rec­tors. This isn’t Had­dock’s first board ap­point­ment, as he al­so cur­rent­ly sits on the board of Co­di­ak Bio­sciences. Pre­vi­ous­ly, Had­dock served as CFO of Ar­ray Bio­phar­ma, and pri­or to that, he was at Bris­tol My­ers Squibb and ArcherDX.

→ Tel Aviv, Is­rael-based Chemomab Ther­a­peu­tics has ex­pand­ed its board of di­rec­tors with four new ap­point­ments. The new hires are Alan Moses, Claude Nicaise, Joel Maryles and Neil Co­hen.

Claude Nicaise

Moses comes with a 14-year stint at No­vo Nordisk un­der his belt, where he served as SVP and glob­al chief med­ical of­fi­cer. Mean­while, Nicaise was SVP of strate­gic de­vel­op­ment and glob­al reg­u­la­to­ry af­fairs at Alex­ion af­ter a 21 year gig at Bris­tol My­ers Squibb.

Maryles hops aboard af­ter ca­reers at Our­Crowd and Cit­i­group In­vest­ment Bank­ing. On the oth­er hand, Co­hen — for­mer­ly the in­ter­im CEO of An­chi­ano Ther­a­peu­tics — comes along af­ter stints at Cas­tel Part­ners and Is­rael Seed Part­ners.

COM­PASS Path­ways has wel­comed Wayne Ri­ley to its board of di­rec­tors. Ri­ley is pres­i­dent of the State Uni­ver­si­ty of New York Down­state Health Sci­ences Uni­ver­si­ty, Brook­lyn and was pre­vi­ous­ly a di­rec­tor at Ver­tex.

Catharine Smith

→ The non-prof­it Ter­meer Foun­da­tion has brought on Catharine Smith as the or­ga­ni­za­tion’s ex­ec­u­tive di­rec­tor. Smith hails from the Clin­ton Foun­da­tion, where she serves as CEO, Clin­ton Health Mat­ters Ini­tia­tive. Pri­or to that, she held var­i­ous lead­er­ship roles at Har­vard Med­ical School.

→ San Fran­cis­co-based Bet­ter Ther­a­peu­tics has signed on An­drew Ar­mani­no and Ge­of­frey Park­er to its board of di­rec­tors. Ar­mani­no re­cent­ly re­tired as man­ag­ing part­ner and CEO at CPA firm Ar­mani­no. Mean­while, Park­er cur­rent­ly serves as COO, CFO and EVP of Tri­ci­da. Pre­vi­ous­ly, Park­er was CFO of Ana­cor Phar­ma­ceu­ti­cals and a man­ag­ing di­rec­tor at Gold­man Sachs.

Ma­ri­na Bozilenko has joined Acel­Rx’s board of di­rec­tors. Bozilenko, a Bear Stearns alum, is present­ly a strate­gic ad­vi­sor for William Blair af­ter 11 years as the in­vest­ment firm’s head of biotech & phar­ma and man­ag­ing di­rec­tor.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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