Amarin fish­es for an­oth­er CFO as down­siz­ing takes hold; Cure­Vac makes a deal, then lines up No­var­tis ex­ec to lead de­vel­op­ment

Tom Reil­ly

→ Mired in flag­ging sales for Vas­cepa, the harsh re­al­i­ties of the cur­rent cli­mate in biotech have hit Amarin as they slice 40% of the work­force — the ma­jor­i­ty of those cuts com­ing from the US com­mer­cial team. And the res­ig­na­tion of CFO Michael Kalb has led Amarin to in­stall Tom Reil­ly as his re­place­ment, ef­fec­tive June 20. Reil­ly had been fi­nance chief at Cara Ther­a­peu­tics since Oc­to­ber 2020; af­ter 14 years of fi­nan­cial roles at No­var­tis, he was Al­ler­gan’s head of fi­nance for the US gen­er­al med­i­cines unit from 2017-20. Un­der CEO Karim Mikhail, who suc­ceed­ed John Thero last year, Amarin hopes the job re­duc­tion will save them $100 mil­lion in the next year.

Myr­i­am Mendi­la

→ The same day that Cure­Vac inked a small deal to buy Frame Can­cer Ther­a­peu­tics for €32 mil­lion ($34 mil­lion), the Ger­man mR­NA play­er al­so dis­closed that chief de­vel­op­ment of­fi­cer Klaus Ed­vard­sen is on his way out on June 30. Big Phar­ma vet Myr­i­am Mendi­la will take over on Feb. 1, 2023, and Ul­rike Gnad-Vogt — Cure­Vac’s SVP area head on­col­o­gy — will bridge the gap in Ed­vard­sen’s place. Mendi­la’s on­col­o­gy chops will come in handy here in light of the buy­out: The world­wide head of med­ical af­fairs and CMO, on­col­o­gy at No­var­tis since 2017, she al­so led glob­al med­ical af­fairs at Roche and US med­ical af­fairs at Genen­tech.

“The ad­di­tion of Frame’s tech­nol­o­gy and tal­ent to Cure­Vac’s on­col­o­gy re­search com­ple­ments our abil­i­ty to iden­ti­fy and val­i­date promis­ing neoanti­gens for our mR­NA can­cer vac­cine pro­grams,” Cure­Vac CEO Franz-Wern­er Haas said of the M&A deal.

Ed­ward Con­ner

→ As Ed­ward Con­ner be­comes CMO of Third Har­mon­ic Bio, an in­flam­ma­to­ry dis­ease biotech with $155 mil­lion worth of fund­ing in the hop­per, chief Na­tal­ie Holles said in a state­ment that she’s “thrilled to be work­ing with Ed again.” Con­ner served as site lead and di­vi­sion head of med­ical and de­vel­op­ment at Au­dentes (now Astel­las Gene Ther­a­pies) when Holles was CEO. Con­ner makes this quick re­turn to Peer Re­view af­ter tak­ing the CMO gig at Lo­can­abio in Ju­ly 2021.

Kurt Gunter

→ With its lead pro­gram in Phase I/II tri­als for ENPP1 and ABCC6 de­fi­cien­cies, In­ozyme has tapped Kurt Gunter as CMO. For the last year, Gunter took on the roles of CMO, cell ther­a­py and head of reg­u­la­to­ry af­fairs at Athenex, feel­ing the pinch of the bear mar­ket with a bud­get over­haul that in­clud­ed an undis­closed num­ber of lay­offs. A Hos­pi­ra vet, Gunter was the med­ical chief at Ku­ur Ther­a­peu­tics be­fore he joined Athenex last spring.

Con­se­quent­ly, Dar­rel Co­hen has an­swered the call to suc­ceed Gunter as CMO, cell ther­a­py at Athenex af­ter a year as the med­ical chief of Biosight. Co­hen was VP of late-phase clin­i­cal de­vel­op­ment at Pfiz­er On­col­o­gy, but left his post in 2019 to lead clin­i­cal de­vel­op­ment at EU­SA Phar­ma.

Frank Karbe

→ San Fran­cis­co-based Bet­ter Ther­a­peu­tics is hand­ing over the reins of the com­pa­ny to Frank Karbe, who will be­gin as pres­i­dent and CEO on Ju­ly 5. In the in­ter­im, cur­rent CEO and co-founder Kevin Ap­pel­baum will con­tin­ue to serve in the role. Karbe makes his way to Bet­ter from My­ovant, where he was pres­i­dent and CFO. Ear­li­er in his ca­reer, Karbe was EVP and CFO of Ex­elix­is and worked as an in­vest­ment banker at Gold­man Sachs.

→ As Ak­ili In­ter­ac­tive preps com­mer­cial launch for its AD­HD video game ther­a­py En­deav­or­Rx in the fall, the com­pa­ny is mak­ing some room on its lead­er­ship team for com­mer­cial vet­er­an Matt Franklin as pres­i­dent and COO to help pave the way. Franklin most re­cent­ly served as gen­er­al man­ag­er of the pre­ci­sion on­col­o­gy busi­ness at Ex­act Sci­ences and be­fore that, was chief com­mer­cial of­fi­cer at Thrive Ear­li­er De­tec­tion. Ear­li­er in his ca­reer, Franklin was CBO for ArcherDX and SVP of glob­al mar­ket­ing and clin­i­cal prod­uct strat­e­gy at Foun­da­tion Med­i­cine.

Lu­ca Sca­vo

Cel­lec­tis nat­ur­al killer part­ner Cy­tovia, which took the SPAC route to Nas­daq with Isle­worth Health­care Ac­qui­si­tion in April, has pegged Lu­ca Sca­vo as CFO and James Priour as chief prod­uct of­fi­cer. Peer Re­view just re­port­ed last week that Sca­vo bolt­ed Evelo Bio­sciences af­ter a year as fi­nance chief, and he’s a Roche/Genen­tech vet who was CFO of Roche Di­ag­nos­tics North Amer­i­ca from 2019-21. Priour spent 11 years at Am­gen be­fore his ap­point­ment as SVP, com­mer­cial at Zymeworks in April 2020, even­tu­al­ly earn­ing a pro­mo­tion to chief com­mer­cial of­fi­cer.

Olivia Zetter

Bob Nelsen is dish­ing out sev­er­al pro­mo­tions at ARCH Ven­ture Part­ners: Ari Nowacek (to part­ner); Sean Kendall (to part­ner, Eu­rope); Corey Rit­ter (to prin­ci­pal); and Ni­lay Thakar (al­so to prin­ci­pal). ARCH is al­so bring­ing Olivia Zetter in­to the fold as a strate­gic ad­vi­sor and ven­ture part­ner. Zetter piv­ots to ARCH af­ter lead­ing gov­ern­ment af­fairs and AI strat­e­gy at Re­silience, which backed up the Brinks truck for a hefty $625 mil­lion Se­ries D this week.

Hu­bert Chen

→ It’s been a whirl­wind for Hu­bert Chen, so let’s break it all down: As 2021 drew to a close, Chen stepped down as CMO of Metacrine to take the same job at ADARx Phar­ma­ceu­ti­cals. But an­oth­er change of scenery awaits, this time as CSO and pres­i­dent of Forte Bio­sciences, which has been re­duced to a pi­anis­si­mo af­ter a flop with its lead atopic der­mati­tis can­di­date re­sult­ed in plum­met­ing shares. Be­fore he was with Metacrine, Chen was chief sci­en­tif­ic and med­ical of­fi­cer for Pfenex.

In­ci­den­tal­ly, ADARx has lined up An­drew Sea­cat as head of tox­i­col­o­gy, join­ing the RNA edit­ing brigade at the San Diego biotech af­ter his time at Zo­genix as se­nior di­rec­tor, phar­ma­col­o­gy and tox­i­col­o­gy. A for­mer prin­ci­pal sci­en­tist at Al­ler­gan, Sea­cat has al­so worked at La Jol­la Phar­ma­ceu­ti­cal as se­nior di­rec­tor, pre­clin­i­cal de­vel­op­ment.

Don’t call him an un­der­dog: Rudy Howard has been ap­point­ed as CFO of Hous­ton-based metasta­t­ic dis­ease play­er Ar­a­vive. Howard most re­cent­ly held the same po­si­tion at vTv Ther­a­peu­tics and SciQuest, and he has al­so served as SVP and CFO at MDS Phar­ma Ser­vices.

John Huynh

→ Led by ex-Forty Sev­en chief Mark Mc­Camish and hav­ing se­cured a $77 mil­lion Se­ries A in Jan­u­ary 2021, San Diego on­colyt­ic virus biotech IconOVir has ap­point­ed John Huynh as its first chief tech­nol­o­gy of­fi­cer. Be­fore his re­cent year-long run as SVP of tech­ni­cal op­er­a­tions at Ring Ther­a­peu­tics, Huynh was PTC Ther­a­peu­tics’ VP of gene ther­a­py tech­ni­cal op­er­a­tions.

An­drew San­dler

→ A cou­ple weeks ago, the FDA lift­ed the par­tial clin­i­cal hold on Alpine Im­mune Sci­ences’ com­bo tri­al with dav­o­ceti­cept and Keytru­da, and the Mitch Gold-led biotech will now wel­come An­drew San­dler as CMO on Aug. 17. San­dler had been CMO of Kiadis, which Sanofi bought for $358 mil­lion in No­vem­ber 2020 to beef up its NK ca­pa­bil­i­ties. A for­mer on­col­o­gy ex­ec at Bay­er, San­dler was al­so CMO at Spec­trum Phar­ma­ceu­ti­cals and Den­dreon. The FDA put up the stop sign on the tri­al in March af­ter a pa­tient death that was “at­trib­uted to car­dio­genic shock.”

→ Over at San Car­los, CA-based can­cer biotech Apex­i­gen, William Duke has signed on as CFO. Duke joins Apex­i­gen from the re­cent­ly shut­tered Kalei­do Bio­sciences, where he al­so served as CFO. He has al­so served in the same po­si­tion at Pul­ma­trix and Va­ler­i­tas.

Hatem Az­im

→ ADC-mind­ed Emer­gence Ther­a­peu­tics, try­ing to chal­lenge the Astel­las/Seagen drug Pad­cev with a Se­ries A near­ing $100 mil­lion back in De­cem­ber, has ap­point­ed Hatem Az­im as CMO. Most re­cent­ly, Az­im was head of on­col­o­gy, ear­ly clin­i­cal de­vel­op­ment at French phar­ma Pierre Fab­re. Be­fore that, he was VP, head of clin­i­cal de­vel­op­ment at In­nate Phar­ma.

Alexan­dra Kropo­to­va

→ The Omi­cron vari­ant forced the NIH to pull the plug on en­roll­ment for the AC­TIV-2 Phase III tri­al in­volv­ing SAB Bio­ther­a­peu­tics’ poly­clon­al an­ti­body, and three months lat­er, the Sioux Falls, SD biotech has named Alexan­dra Kropo­to­va as CMO. Kropo­to­va end­ed her eight-year as­so­ci­a­tion with Sanofi by serv­ing as VP, strat­e­gy & strate­gic plan­ning head, North Amer­i­can med­ical af­fairs be­fore leav­ing in 2016 for Te­va, where she was ther­a­peu­tic area head, glob­al spe­cial­ty R&D.

Michael Gold­stein

→ Oph­thal­mol­o­gy start­up Au­ri­on Biotech, which snagged a nice $120 mil­lion ear­li­er this year in a bid to scale cell ther­a­py for a form of blind­ness, has waved in Michael Gold­stein as pres­i­dent and CMO. Pri­or to his new role, Gold­stein was pres­i­dent and CMO of Oc­u­lar Ther­a­peu­tix and CMO of Ap­plied Ge­net­ic Tech­nolo­gies Corp. Ear­li­er in his ca­reer, Gold­stein was with Eleven Bio­ther­a­peu­tics, where he held a num­ber of roles, in­clud­ing CMO and VP of clin­i­cal re­search.

Dustin Haines

→ While Gilead cel­e­brates its 10-year an­niver­sary in Asia, the com­pa­ny has brought aboard Dustin Haines as VP, gen­er­al man­ag­er, Asia 5. Haines will be re­spon­si­ble for dri­ving the busi­ness de­vel­op­ment of HIV, vi­ral he­pati­tis in­clud­ing he­pati­tis B, C and D, as well as Gilead’s com­mit­ment to en­hance pub­lic health and com­mu­ni­ty im­pact in the Asia 5 mar­kets: Hong Kong, Sin­ga­pore, South Ko­rea, Tai­wan and Malaysia. Haines hails from Next Sci­ence, where he was CCO. Pri­or to that, Haines spent over a decade at Vi­iV Health­care (pres­i­dent and gen­er­al man­ag­er for Japan) and GSK.

→ Liv­er dis­ease-fo­cused Inipharm has brought on Chuhan Chung as CMO. Chung joins the com­pa­ny from Gilead, where he served as ex­ec­u­tive di­rec­tor and glob­al de­vel­op­ment lead and was re­spon­si­ble for clin­i­cal stud­ies in NASH and pri­ma­ry scle­ros­ing cholan­gi­tis. Pri­or to Gilead, Chung was an as­so­ciate pro­fes­sor at Yale Uni­ver­si­ty School of Med­i­cine, sec­tion of gas­troen­terol­o­gy & he­pa­tol­ogy.

Sara Weymer

→ Tak­ing aim at ex­tra­chro­mo­so­mal DNA (ecD­NA) to treat can­cer, Bound­less Bio has in­tro­duced Sara Weymer as VP of clin­i­cal op­er­a­tions. From 2016-21, Weymer led clin­i­cal op­er­a­tions at Fate Ther­a­peu­tics, whose iP­SC-de­rived nat­ur­al killer ther­a­pies have run in­to dura­bil­i­ty is­sues that sound the alarm bells but don’t nec­es­sar­i­ly spell doom. Ear­li­er in her ca­reer, Weymer was a se­nior clin­i­cal tri­al man­ag­er at Bio­gen.

→ AAV gene ther­a­py out­fit Ap­plied Ge­net­ic Tech­nolo­gies Cor­po­ra­tion has two ap­point­ments to an­nounce this week: Ed­uar­do Ja­cobo as SVP of GMP man­u­fac­tur­ing and David Ja­cobs as SVP of clin­i­cal re­search and med­ical af­fairs. Pri­or to join­ing AGTC, Ja­cobo ran GMP gene man­u­fac­tur­ing at Sang­amo, and he has al­so held nu­mer­ous man­u­fac­tur­ing po­si­tions at Am­gen and Eli Lil­ly. Ja­cobs comes to AGTC af­ter lead­ing clin­i­cal pro­grams at Bio­gen and Dai­ichi Sankyo.

Bri­an Stam­per

→ On the cusp of a Phase III tri­al with its den­drit­ic cell ther­a­py ITI-1000 for glioblas­toma mul­ti­forme, Im­mu­nom­ic Ther­a­peu­tics has se­lect­ed Bri­an Stam­per as VP, cell ther­a­py op­er­a­tions. A vet­er­an of Eli Lil­ly and As­traZeneca Bi­o­log­ics, Stam­per had a short run at Lon­za be­fore his most re­cent post as se­nior di­rec­tor of man­u­fac­tur­ing at Kite.

Al­fre­do Barón

→ CNS-fo­cused Neu­rax­pharm Group has tapped Al­fre­do Barón as the new coun­try man­ag­er of Neu­rax­pharm Spain, tak­ing over for Javier Mer­cadé — who has been ap­point­ed head of growth mar­kets. Barón joins Neu­rax­pharm from Almi­rall, where he most re­cent­ly served as EVP of glob­al com­mer­cial op­er­a­tions and CCO. Be­fore his most re­cent role at Almi­rall, Barón was di­rec­tor of sales and mar­ket­ing man­ag­er, cor­po­rate man­ag­ing di­rec­tor for south and east­ern Eu­rope and EVP and man­ag­ing di­rec­tor of Eu­rope for the com­pa­ny.

→ Da­ta man­age­ment out­fit Dot­mat­ics, which was snapped up by In­sight­ful Sci­ence last March, has named Lar­ry Samuel­son as chief le­gal of­fi­cer and Neil Frye as chief peo­ple of­fi­cer. Samuel­son most re­cent­ly served as SVP, gen­er­al coun­sel and cor­po­rate sec­re­tary of Cvent, while Frye is the for­mer chief peo­ple of­fi­cer of Al­to Phar­ma­cy and has pre­vi­ous­ly held roles at Drop­box, Google and Ac­cen­ture.

→ Duarte, CA-based Pro­lac­ta Bio­science has reeled in David Stein­berg as CFO. Stein­berg joins with ex­pe­ri­ence from pre­vi­ous stints at Jef­feries (man­ag­ing di­rec­tor) and Deutsche Bank un­der his belt.

Seth Van Voorhees

→ The board of di­rec­tors at NRx Phar­ma­ceu­ti­cals has re­cruit­ed Seth Van Voorhees as CFO and trea­sur­er. Van Voorhees hops aboard from PDS Biotech­nol­o­gy, where he al­so wore the CFO hat. Pri­or to that, he served a 10-year gig as CFO for Re­search Fron­tiers and for Amer­i­can Pa­cif­ic. Ear­li­er in his ca­reer, Van Voorhees served at Mer­rill Lynch, UBS War­burg and Wasser­stein Perel­la.

→ Cam­bridge, UK-based Metri­on Bio­sciences has ap­point­ed Benedet­ta Mon­tagni­ni as head of Eu­ro­pean busi­ness de­vel­op­ment. Mon­tagni­ni pre­vi­ous­ly served as busi­ness de­vel­op­ment man­ag­er at Eu­rofins Dis­cov­ery and Dis­cov­eRx. Be­fore that, Mon­tagni­ni was ac­count man­ag­er for the in­dus­tri­al bio­pro­cess­ing di­vi­sion at In­vit­ro­gen.

Kathryn Boor

Putting on a unit­ed front last month with oth­er Duchenne drug­mak­ers on why safe­ty prob­lems have dogged the in­di­ca­tion, Sarep­ta has added Michael Cham­bers and Kathryn Boor to its board of di­rec­tors. Cham­bers co-found­ed and was the long­time CEO of Alde­vron, and Boor is the dean of Cor­nell’s grad­u­ate school as well as vice provost for grad­u­ate ed­u­ca­tion.

Bahi­ja Jal­lal’s Im­muno­core has ap­point­ed Sid­dharth Kaul to the board of di­rec­tors. The re­tired Kaul last served as group trea­sur­er and head of busi­ness plan­ning and analy­sis at No­var­tis in 2021, where he spent 17 years of his ca­reer in such roles as CFO, phar­ma Eu­rope and CFO, phar­ma US.

Gre­go­ry Fiore

→ Like Hall of Fame col­lege bas­ket­ball coach Roy Williams sub­bing out an en­tire line­up, Brook­lyn Im­munoTher­a­peu­tics is putting new board mem­bers on the floor af­ter last week’s CEO change. In­ter­im chief Matt An­gel leads the list of names, fol­lowed by Exacis Bio­ther­a­peu­tics CEO Gre­go­ry Fiore, Pur­chase Cap­i­tal founder Nicholas Singer and Homer City Hold­ings chair­man and CEO Bill Wexler. Gone are Erich Mohr, Den­nis Langer, Heather Red­man, and Erin En­right, ef­fec­tive June 5.

→ With bil­lion­aire Ric Kayne sus­pend­ing his at­tempt to over­haul the board of di­rec­tors, Seat­tle Alzheimer’s biotech Athi­ra Phar­ma is mov­ing for­ward with a new sci­en­tif­ic ad­vi­so­ry board. Chaired by Athi­ra CMO Hans Moe­bius, the board will con­sist of An­ton Porsteins­son, John Olich­ney, Mar­wan Sab­bagh, Lon Schnei­der, Pierre Tairot and Paul Win­ner.

Janet Loes­berg

Am­brx Bio­phar­ma has boost­ed its board of di­rec­tors with Blue­print Med­i­cines SVP of glob­al med­ical af­fairs Janet Loes­berg. A 12-year Bris­tol My­ers Squibb vet, Loes­berg was briefly the VP, head of port­fo­lio and project man­age­ment, R&D for J&J’s Janssen.

Robert Hariri’s Celu­lar­i­ty has elect­ed for­mer Kite head of US com­mer­cial Di­ane Parks to the board of di­rec­tors. Parks adds the cell ther­a­py biotech to her list of board re­spon­si­bil­i­ties, which in­cludes posts at Cal­lid­i­tas Ther­a­peu­tics, CTI Bio­Phar­ma and Ku­ra On­col­o­gy.

Saira Ra­masas­try

Life Sci­ences Ad­vi­so­ry man­ag­ing part­ner Saira Ra­masas­try has been giv­en a seat on the board of di­rec­tors at Mirum Phar­ma­ceu­ti­cals. This is the lat­est in a string of cur­rent board ap­point­ments for Ra­masas­try at Vir, Glen­mark, Day One Bio­phar­ma­ceu­ti­cals and Ak­ou­os.

→ Cys­tic fi­bro­sis play­er Sion­na Ther­a­peu­tics has made room for Paul Clan­cy on the board of di­rec­tors. The for­mer CFO of Alex­ion (2017-19) and Bio­gen (2007-17) is on the boards of In­cyte, Ex­act Sci­ences and Xilio Ther­a­peu­tics.

Jen­nifer Zachary has clinched a spot on the board of di­rec­tors at Rockville, MD-based Re­genxbio, which has been in a patent squab­ble over Zol­gens­ma with No­var­tis. Zachary has been Mer­ck’s gen­er­al coun­sel since April 2018.

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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