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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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