Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at Cata­ma­ran Bio, team­ing up again with ex-Dis­arm CEO

Jane Gro­gan

→ Gene edit­ing play­er Graphite Bio notched a $150 mil­lion Se­ries B megaround to boost its to­tal to $195 mil­lion, and a month lat­er, Jane Gro­gan is mov­ing from an­oth­er start­up to be Graphite’s CSO. Gro­gan is leav­ing Ar­se­nal­Bio af­ter serv­ing as chief sci­en­tist since its launch in Oc­to­ber 2019. She was at Genen­tech from 2004-19, with her last five years as head of adap­tive tu­mor im­mu­ni­ty and prin­ci­pal sci­en­tist of can­cer im­munol­o­gy dis­cov­ery re­search.

Graphite Bio looks to set it­self apart in a sick­le cell field that al­ready con­sists of such names as Ver­tex/CRISPR, blue­bird bio and Glob­al Blood Ther­a­peu­tics — where Graphite CEO Josh Lehrer was once CMO — with its lead can­di­date GPH101.

Scott Holmes

→ Just a dream and the wind to car­ry him: Sail­ing takes Scott Holmes away to the CFO post at Cata­ma­ran Bio, the CAR-NK cell ther­a­py play­er with Alvin Shih now in place at the top spot. It re­unites the pair af­ter Shih cap­tained the boat at Dis­arm Ther­a­peu­tics be­fore Eli Lil­ly pur­chased the com­pa­ny for $135 mil­lion up­front, with Holmes as his CFO. Holmes al­so brings CFO ex­pe­ri­ence from Kiadis Phar­ma and Keryx Bio­phar­ma­ceu­ti­cals, where he en­gi­neered the merg­er with Ake­bia in 2018. Cata­ma­ran Bio made its de­but in No­vem­ber with a $42 mil­lion Se­ries A round.

→ San Fran­cis­co age-re­lat­ed dis­ease biotech Foun­tain Ther­a­peu­tics has tapped William Greene as CEO while he con­tin­ues to helm Icon­ic Ther­a­peu­tics, which he’s led since 2014. Greene, a for­mer MPM Cap­i­tal ven­ture part­ner who cut his teeth help­ing de­vel­op such drugs at Lu­cen­tis as a clin­i­cal sci­en­tist and epi­demi­ol­o­gist at Genen­tech, co-found­ed Pear Ther­a­peu­tics in 2013 with Corey Mc­Cann and Stephen Smith.

Al­i­son O’Neill

→ The C-suite is com­ing to­geth­er at Sur­face On­col­o­gy with the pro­mo­tions of Al­i­son O’Neill and Jes­si­ca Fees and the ar­rival of Hen­ry Rath. O’Neill, the new CMO, joined Sur­face in 2018 as VP of clin­i­cal de­vel­op­ment af­ter a cou­ple years in the same ca­pac­i­ty at Ra­dius Health, and she’s worked in Sanofi’s glob­al on­col­o­gy di­vi­sion as se­nior di­rec­tor. Fees takes the CFO job and has been with the biotech since 2014, mak­ing the leap from her for­mer role of SVP of fi­nance. Mean­while, Rath em­barks on his sec­ond CBO gig, leav­ing that po­si­tion at TScan. He’s an Am­gen vet who was SVP, cor­po­rate de­vel­op­ment at Seres from 2015-19.

Will Mc­Carthy

→ That’s all for the Gen­e­sis Ther­a­peu­tics CBO search as Will Mc­Carthy lands the job. Mc­Carthy piv­ots to the AI biotech, spun out of Stan­ford and led by CEO Evan Fein­berg, af­ter CBO stints at Gen­er­a­tion Bio and Igny­ta, which Roche snapped up for $1.7 bil­lion. Af­ter a short stay at Bio­gen, Mc­Carthy was with Halozyme from 2007-14 and then be­came VP, cor­po­rate de­vel­op­ment at Foun­da­tion Med­i­cine. Gen­e­sis Ther­a­peu­tics raked in a $52 mil­lion Se­ries A round back in De­cem­ber af­ter part­ner­ing with Genen­tech to uti­lize the AI ca­pa­bil­i­ties that help “get them pre­pared for clin­i­cal tri­als more quick­ly, and with a more op­ti­mal com­pound,” Fein­berg told End­points News.

Deb­o­rah As­cheim has signed on to be CMO at Stride­Bio, an AAV-based gene ther­a­py de­vel­op­er in the Re­search Tri­an­gle area. As­cheim’s pre­vi­ous CMO ex­pe­ri­ence was with Lin­da Mar­bán’s team at Capri­cor from 2015-19, and the ex-Ic­ahn School of Med­i­cine pro­fes­sor had been do­ing some in­de­pen­dent con­sult­ing work as pres­i­dent of d2a.

Bri­an Zhang

→ Af­ter mak­ing the ad­di­tion of Nicholas Des­jardins as CFO and cor­po­rate de­vel­op­ment of­fi­cer last week, Hi­malaya Ther­a­peu­tics has tapped Bri­an Zhang as CEO. Zhang comes from Roche, where he helped lead the de­vel­op­ment of Xeni­cal and the dis­cov­ery of Dorza­gli­atin, among oth­ers.

→ Men­lo Park, CA-based Co­hBar has pulled in Joseph Sar­ret to steer the helm of the com­pa­ny as CEO and di­rec­tor — suc­ceed­ing Steven En­gle. Sar­ret joins the mi­to­chon­dria-based ther­a­peu­tics com­pa­ny from Cori­um In­ter­na­tion­al, where he served as CBO. Sar­ret’s pre­vi­ous ex­pe­ri­ence in­cludes stints at So­lazyme, Sev­i­dent and Codex­is.

In ad­di­tion to Sar­ret’s ap­point­ment, Co­hBar has pro­mot­ed David Green­wood as chair­man of the board. Green­wood joined the board in April 2019.

Tere­sa McRoberts

→ Austin city lim­its: T cell ther­a­py-fo­cused Tri­umvi­ra out of Texas is shoring up its lead­er­ship team af­ter launch­ing last sum­mer with a $55 mil­lion round, nam­ing Tere­sa McRoberts CFO while pro­mot­ing An­dreas Bad­er to CSO and Jon Irvin to SVP of fi­nance. McRoberts leads the tri­umvi­rate with pre­vi­ous cred­its that in­clude Mor­gan Stan­ley and JP Mor­gan, and she comes to Tri­umvi­ra af­ter serv­ing as port­fo­lio man­ag­er, SVP and se­nior an­a­lyst at Al­ger Man­age­ment. Be­fore head­ing to Tri­umvi­ra in 2018 as SVP of R&D, Bad­er co-found­ed and was CEO of Or­ros Ther­a­peu­tics and was sci­en­tif­ic co-founder of Mir­na Ther­a­peu­tics. Irvin was al­so with Mir­na as CFO be­fore ar­riv­ing on the scene as VP of fi­nance for Tri­umvi­ra in 2018.

Trevor Hal­lam has been pro­mot­ed to pres­i­dent of re­search and CSO of Sutro Bio­phar­ma, which be­gan the dose-ex­pan­sion co­hort for its Phase I ovar­i­an can­cer study in Jan­u­ary. Hal­lam has his share of Big Phar­ma bona fides from As­traZeneca and Roche, and he’s been Sutro’s CSO since De­cem­ber 2010. Be­fore his Sutro tenure be­gan, he was EVP of R&D at Palatin Tech­nolo­gies.

Gra­ham Dempsey

→ Six months in­to the Paul Medeiros era, CNS-fo­cused Q-State Bio­sciences has hand­ed out a pro­mo­tion to Gra­ham Dempsey (CSO and head of R&D) while putting out the wel­come mat for CFO Chris Watt and gen­er­al coun­sel Jim Ja­cob­son. Dempsey came to Q-State out of Har­vard in 2014 as a se­nior sci­en­tist, climb­ing to SVP of R&D in short or­der. Ja­cob­son makes the switch af­ter be­ing Mer­ck KGaA’s se­nior at­tor­ney and chief US pri­va­cy coun­sel, with ex­pe­ri­ence that dates back to his par­tic­i­pa­tion in the health­care task force for the Clin­ton White House. Watt de­vot­ed more than 10 years to Bio­gen and then be­came SVP, head of fi­nance at Tetraphase un­til La Jol­la Phar­ma­ceu­ti­cal bought the com­pa­ny last sum­mer.

→ With its lead drug EDG-5506 geared to­ward Duchenne and Beck­er mus­cu­lar dy­s­tro­phy, Edge­wise Ther­a­peu­tics out of Boul­der, CO has called up­on Joanne Dono­van to be CMO, tak­ing over the po­si­tion briefly held by Kirsten Gruis. Dono­van is a 13-year Gen­zyme vet who was CMO and SVP, clin­i­cal de­vel­op­ment at Cataba­sis, where she spent 10 more years.

Vat­nak Vat-Ho

→ Pol­ish on­col­o­gy biotech Ryvu Ther­a­peu­tics has re­cruit­ed Vat­nak Vat-Ho as CBO. Be­fore tak­ing on his first CBO as­sign­ment at Ryvu — based in Krakow with se­lec­tive CDK8/CDK19 ki­nase in­hibitor RVU120 in its pipeline — Vat-Ho was Af­fimed’s VP of busi­ness de­vel­op­ment. And fur­ther back, he round­ed out his eight years at Pfiz­er as se­nior di­rec­tor/team lead, strat­e­gy, busi­ness de­vel­op­ment & al­liance.

→ Bev­er­ly Hills im­muno-on­col­o­gy biotech GT Bio­phar­ma has named Gre­go­ry Berk CMO while he re­signs from his board seat, mov­ing the Uni­ver­si­ty of Min­neso­ta’s Jef­frey Miller — the in­ven­tor of the TriKE tech­nol­o­gy plat­form that GT Bio­phar­ma uti­lizes — from con­sult­ing CMO to con­sult­ing CSO. Berk just com­plet­ed a fleet­ing stay as CMO of Celu­lar­i­ty and has al­so held the same ti­tle at Ve­rastem and Sideris Phar­ma­ceu­ti­cals.

Elas­trin Ther­a­peu­tics has wel­comed Pe­dro Quin­tana Diez to its lead­er­ship team as CMO. Quin­tana Diez jumps aboard from Sen­so­ry Sci­ences, where he al­so served as CMO. In ad­di­tion, Quin­tana Diez has held roles at Grunen­thal, Ab­b­Vie and Parin­Genix.

Ale­jan­dra Car­va­jal

→ An­ti­body-drug con­ju­gate (ADC) biotech Mer­sana Ther­a­peu­tics out of Cam­bridge, MA has brought on Ale­jan­dra Car­va­jal as SVP and chief le­gal of­fi­cer. Car­va­jal was pre­vi­ous­ly chief le­gal of­fi­cer, gen­er­al coun­sel & sec­re­tary at Mo­men­ta, nav­i­gat­ing the le­gal work dur­ing J&J’s $6.5 bil­lion buy­out. Ad­di­tion­al­ly, she held mul­ti­ple roles at Mil­len­ni­um and was the VP, gen­er­al coun­sel at Cerulean Phar­ma.

→ San Diego-based Shore­line Bio­sciences has named its co-founder William Sand­born as CMO. Sand­born was on the fac­ul­ty of the Mayo Clin­ic from 1993-2010. Af­ter that, he served as pro­fes­sor of med­i­cine, chief of the di­vi­sion of gas­troen­terol­o­gy and di­rec­tor of the In­flam­ma­to­ry Bow­el Dis­ease Cen­ter at the Uni­ver­si­ty of Cal­i­for­nia San Diego. He was a sci­en­tif­ic co-founder of San­tarus (ac­quired by Sal­ix Phar­ma­ceu­ti­cals, now Bausch Health). Cur­rent­ly, he serves on the SAB of Prometheus Bio­sciences.

Katie Laes­sig

→ A cou­ple weeks back, An­tios Ther­a­peu­tics chalked up a $96 mil­lion Se­ries B round, with CEO Greg Mayes in­di­cat­ing to End­points that they’re “go­ing to be pre­pared” for an IPO. An­tios has sub­se­quent­ly brought on Katie Laes­sig as SVP, glob­al reg­u­la­to­ry af­fairs and Karen Fusaro as SVP, clin­i­cal op­er­a­tions. A 16-year FDA alum, Laes­sig makes the switch to An­tios from her role of VP, ther­a­peu­tic strat­e­gy, strate­gic drug de­vel­op­ment at IQVIA. Fusaro’s Big Phar­ma in­volve­ment com­pris­es of glob­al clin­i­cal de­vel­op­ment at No­var­tis and glob­al clin­i­cal tri­als for HIV, mi­graine and oth­er can­di­dates at GSK, and more re­cent­ly she was VP, clin­i­cal and reg­u­la­to­ry op­er­a­tions at Melin­ta Ther­a­peu­tics.

Dirk Stevens

Dirk Stevens has tak­en on the role of SVP, qual­i­ty as­sur­ance and reg­u­la­to­ry af­fairs at MiMedx — look­ing to put a tu­mul­tuous past be­hind them — af­ter two years as VP, glob­al reg­u­la­to­ry af­fairs at Smith & Nephew. Stevens has al­so been a reg­u­la­to­ry ex­ec at Fre­se­nius Med­ical Care and served at J&J, Bax­ter Health­care and Co­vi­di­en.

→ Fre­mont, CA-based biotech Cytek Bio­sciences — which closed a $120 mil­lion Se­ries D round last No­vem­ber — has bagged Allen Poir­son as SVP of mar­ket­ing and cor­po­rate de­vel­op­ment. Poir­son hails from twoXAR Phar­ma­ceu­ti­cals, where he served as SVP of bio­phar­ma­ceu­ti­cal busi­ness de­vel­op­ment. Pri­or to that, he was CEO of Sony Biotech­nol­o­gy and Ac­cuim­age Di­ag­nos­tics.

Chris­tine Lind

Im­mu­nicum in­ter­im chair Chris­tine Lind has joined the NDA Group as VP of com­mer­cial. Most re­cent­ly, Lind served as strat­e­gy and busi­ness de­vel­op­ment ad­vi­sor at BioArc­tic AB. Pri­or to that, Lind was CEO of Medi­vir and had a decade-long stint at Mer­rill Lynch.

Aru­vantVivek Ra­maswamy’s sick­le cell Vant — has wel­comed Meghan Kel­ton as ex­ec­u­tive di­rec­tor of hu­man re­sources and Blair Clark-Schoeb as SVP of com­mu­ni­ca­tions. Kel­ton was a strate­gic HR leader at J&J and then moved on to No­var­tis Gene Ther­a­pies (pre­vi­ous­ly AveX­is) as peo­ple and or­ga­ni­za­tion head and HR site lead. Clark-Schoeb has been SVP, com­mu­ni­ca­tions at Zy­la Life Sci­ences, and ear­ly in her ca­reer she was se­nior di­rec­tor of cor­po­rate fi­nance for The Med­i­cines Com­pa­ny.

Philippe Dro

Philippe Dro has signed on to be a part­ner at Glenn Rock­man’s Ad­ju­vant Cap­i­tal. The chair­man of Scenic Biotech, Lu­ci­ole Med­ical and Lim­maT­e­ch Bi­o­log­ics, Dro was CBO of vac­cine de­vel­op­er Themis un­til it was sold to Mer­ck last year, and he al­so helmed Swiss-based Gly­co­V­axyn be­fore its 2015 ac­qui­si­tion by GSK for $190 mil­lion.

→ Mov­ing on from his Ver­tex crash-and-burn, the Ian Smith recla­ma­tion project has made its way to the board of di­rec­tors at Adri­an Gottschalk’s Foghorn Ther­a­peu­tics. Last sum­mer, Smith be­came chair­man at Sol­id Bio and he’s the ex­ec­u­tive chair­per­son at Vi­a­Cyte.

Mark Vel­le­ca

Mark Vel­le­ca has been named chair­man of the board at Tur­bine, a Hun­gar­i­an drug dis­cov­ery com­pa­ny us­ing a sim­u­la­tion-based ap­proach for its on­col­o­gy ther­a­pies. Vel­le­ca had been CEO of G1 Ther­a­peu­tics from 2014 un­til he hand­ed the ba­ton to Jack Bai­ley at the start of this year. On top of that, Gor­don Mills and Klaus Hoe­flich are now on Tur­bine’s sci­en­tif­ic ad­vi­so­ry board.

→ Af­ter reel­ing in for­mer Jef­feries an­a­lyst Biren Amin ear­li­er this month, Im­muneer­ing has now se­lect­ed Lau­rie Keat­ing to be a part of its board of di­rec­tors. Keat­ing cur­rent­ly serves as EVP and chief le­gal of­fi­cer of Al­ny­lam. This isn’t Keat­ing’s first board ap­point­ment, oc­cu­py­ing a seat on the board of Mass­Bio. Pri­or to Al­ny­lam, Keat­ing was with Mil­len­ni­um and Hy­dra Bio­sciences.

Su­san­nah Gray

Otel­lo Stam­pac­chia is no longer on the board of di­rec­tors at Mor­phic Ther­a­peu­tic, leav­ing the door open for Su­san­nah Gray to join. Gray re­tired from Roy­al­ty Phar­ma in 2019 af­ter 14 years as EVP and CFO. In oth­er Mor­phic board news, Vikas Goy­al won’t seek re­elec­tion when his term runs out at the Waltham, MA biotech.

Finch Ther­a­peu­tics — which scored $90 mil­lion to com­plete the fi­nal stretch for its oral mi­cro­bio­me ther­a­py last Sep­tem­ber — has en­list­ed for­mer Roche ex­ec Su­san Graf for its board of di­rec­tors. Cur­rent­ly, Graf serves as CEO of Aka­ma­ra Ther­a­peu­tics. Graf was al­so the for­mer CBO and prin­ci­pal fi­nan­cial of­fi­cer of Epizyme. Be­fore that, Graf was with NPS Phar­ma.

John Ko­co­nis

→ Sev­er­al months af­ter Alan Mendel­sohn took the CMO reins, der­ma­to­log­ic dis­ease-fo­cused Tim­ber Phar­ma­ceu­ti­cals has made its CEO John Ko­co­nis chair­man of the board. More­over, two board mem­bers have been as­signed new ti­tles: Ed­ward Sitar has been ap­point­ed lead in­de­pen­dent di­rec­tor, while David Co­hen chairs Tim­ber’s Sci­ence and Tech­nol­o­gy Com­mit­tee.

Akero Ther­a­peu­tics — which surged off of “un­prece­dent­ed” NASH da­ta last Ju­ly, just days af­ter a crush­ing re­jec­tion for In­ter­cept —  has opened a seat on its board for Yuan Xu as an in­de­pen­dent di­rec­tor. Xu brings with her ex­pe­ri­ence from her time as CEO of Leg­end Biotech, which reeled in a $424 mil­lion mon­ster IPO last year with her at the helm. Be­fore that, Xu was at Mer­ck’s bi­o­log­ics & vac­cines sub­di­vi­sion as well as man­u­fac­tur­ing groups for No­var­tis, Gilead and GSK.

James Sco­pa

→ Af­ter strik­ing a NASH deal with Mer­ck that could be val­ued at $458 mil­lion, South San Fran­cis­co liv­er dis­ease biotech Ali­gos Ther­a­peu­tics has made room for ex-MPM Cap­i­tal man­ag­ing di­rec­tor James Sco­pa on the board of di­rec­tors. Sco­pa claims board seats at sev­er­al oth­er com­pa­nies, in­clud­ing DiCE Mol­e­cules and Neu­ron23.

Emerg­ing from stealth mode, se­cur­ing an up­sized IPO and get­ting hit with a clin­i­cal hold all in a short pe­ri­od of time, Mar­cio Souza’s crew at Prax­is Pre­ci­sion Med­i­cines has its sec­ond new board mem­ber in as many weeks: Mass Gen­er­al Hos­pi­tal chief of neu­rol­o­gy Mer­it Cud­kow­icz. Re­tired Ver­tex and Mer­ck ex­ec Jef­frey Chodake­witz has like­wise head­ed to the board at Prax­is, which has ac­cept­ed the res­ig­na­tions of Black­stone’s Nick Galakatos and Ki­ran Red­dy, Prax­is’ co-founder and ex-CEO.

Vic­ki Vakiener

→ Try­ing to re­hab their im­age af­ter the Josh Hardy af­fair, Chimerix has re­served a seat for Vic­ki Vakiener on the board of di­rec­tors. Vakiener was pro­mot­ed to chief com­mer­cial of­fi­cer of Epizyme in Sep­tem­ber.

Mary Lynne Hed­ley is adding an­oth­er board seat to her ré­sumé with her new ap­point­ment at Helsinn. Most re­cent­ly, Hed­ley was di­rec­tor, pres­i­dent and COO at Tesaro. Pri­or to Tesaro, Hed­ley was with Abrax­is Bio­science, Ei­sai, MGI Phar­ma and ZY­COS. Hed­ley cur­rent­ly sits on the boards of Vee­va and Centes­sa Phar­ma­ceu­ti­cals.

Joanne Cur­ley

→ CNS biotech Vista­Gen has added Joanne Cur­ley to the board of di­rec­tors. Cur­ley, who was with Gilead for near­ly 15 years, was named chief de­vel­op­ment of­fi­cer at Ve­ra Ther­a­peu­tics last year.

Defini­GEN has ap­point­ed Ben Cons as chair­man of the board. Cons pre­vi­ous­ly held a 20-year stint at IQVIA and the as­so­ci­at­ed No­vaQue­st in­vest­ment fund. Cur­rent­ly, Cons is chair­man of Cas­tor EDC and Charn­wood Mol­e­c­u­lar, among oth­ers. Cons jump­start­ed his ca­reer at Bay­er­Scher­ing and GSK.

Er­rol de Souza has been elect­ed to the board of di­rec­tors at Cy­cle­ri­on Ther­a­peu­tics, which saw a Phase II flop with olin­ciguat for sick­le cell dis­ease last Oc­to­ber. The Neu­ro­crine founder and ex­ec­u­tive chair­man of Bio­nom­ics is on the boards of Roy­al­ty Phar­ma and Cat­a­lyst Bio­sciences.

Er­gomed has made the ad­di­tion of Llew Kelt­ner to its board of di­rec­tors, re­plac­ing Ian John­son. Kelt­ner brings ex­pe­ri­ence from his time as chair­man of Rap­tor Phar­ma­ceu­ti­cals and as a mem­ber of the board of Mannkind.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 144,300+ biopharma pros reading Endpoints daily — and it's free.