With Kathy High on board, AskBio makes next lead­er­ship play and se­lects Bay­er's Gu­ru Ra­ma­murthy as fi­nance chief; Myles O'Neill and Melis­sa Barnes set to re­tire from Eli Lil­ly

Gu­ru Ra­ma­murthy

→ The stars aligned to bring in Kathy High as pres­i­dent of ther­a­peu­tics, and Brain Neu­rother­a­py Bio founder Krystof Bankiewicz now leads its Parkin­son’s pro­gram. And in its first big lead­er­ship move since they signed on to the team, gene ther­a­py play­er AskBio has ap­point­ed Gu­ru Ra­ma­murthy CFO, a spokesper­son tells End­points News. Six months re­moved from strik­ing a deal to ac­quire AskBio, it should come as no sur­prise that Ra­ma­murthy is a 20-year Bay­er alum: More re­cent­ly he had been the Ger­man multi­na­tion­al’s glob­al fi­nance lead for the on­col­o­gy fran­chise, and pri­or to that, Ra­ma­murthy was CFO of the North Amer­i­can busi­ness at Bay­er Con­sumer Health.

Myles O’Neill

→ Long­time staffers Myles O’Neill (SVP and pres­i­dent of man­u­fac­tur­ing op­er­a­tions) and Melis­sa Barnes (SVP and chief ethics and com­pli­ance of­fi­cer) are re­tir­ing at Eli Lil­ly. The cur­tain clos­es for O’Neill at the In­di­anapo­lis phar­ma on May 2, while Barnes’ last day is June 27.

Melis­sa Barnes

O’Neill’s suc­ces­sor, Edgar­do Her­nan­dez, has been with Lil­ly since 2009 and will round out his tenure as SVP, glob­al par­enter­al drug prod­uct and de­vice man­u­fac­tur­ing. Alon­zo Weems, who is Lil­ly’s VP and deputy gen­er­al coun­sel, will re­place Barnes and has de­vot­ed near­ly a quar­ter-cen­tu­ry to the phar­ma gi­ant.

Alex Franzu­soff has re­tired as CEO of South San Fran­cis­co T cell biotech PACT Phar­ma, while the Scott Gar­land era of­fi­cial­ly be­gan Fri­day. Gar­land pre­vi­ous­ly helmed Por­to­la for two years un­til Alex­ion com­plet­ed its $1.4 bil­lion pur­chase of the com­pa­ny in Ju­ly 2020. Gar­land, who was with Genen­tech from 2002-11 and led sales and mar­ket­ing for Avastin and Rit­ux­an, then be­came CCO at Ex­elix­is and Re­lyp­sa, fin­ish­ing his tenure at the lat­ter as pres­i­dent of the US com­mer­cial launch of Veltas­sa.

Franzu­soff will stay on for a few more months at PACT Phar­ma in an ad­vi­so­ry ca­pac­i­ty.

Ty How­ton

Ty How­ton has re­unit­ed with CEO Bo Cum­bo to take on the roles of COO and gen­er­al coun­sel at Aa­van­tiBio. Cum­bo and How­ton’s tenures at Sarep­ta co­in­cid­ed with one an­oth­er when Cum­bo was chief com­mer­cial of­fi­cer and How­ton was a le­gal ex­ec, more re­cent­ly as the Duchenne biotech’s gen­er­al coun­sel. How­ton al­so brings ex­pe­ri­ence from Ver­tex as its chief le­gal of­fi­cer and Genen­tech as its chief health­care com­pli­ance of­fi­cer. His ap­point­ment quick­ly fol­lows that of Dou­glas Swirsky as CFO and trea­sur­er, which we had for you here last week.

John Schroer

Join­ing forces with Bris­tol My­ers Squibb on T cell ther­a­pies for sol­id tu­mors — with Bris­tol shelling out $70 mil­lion up­front — Ar­se­nal­Bio has tapped John Schroer as CFO and Tim Siri­choke as chief tech­ni­cal op­er­a­tions of­fi­cer. Schroer had been Trans­late Bio’s CFO since the spring of 2018, while Siri­choke is a No­var­tis vet who ar­rives at Ar­se­nal­Bio af­ter a stint at Genen­tech as VP of In­di­vid­u­al­ized Neo-Anti­gen Spe­cif­ic Ther­a­pies (IN­eST) man­u­fac­tur­ing.

→ Woburn, MA-based Ax­i­al Ther­a­peu­tics has pro­mot­ed Stew­art Camp­bell to the po­si­tion of CEO, suc­ceed­ing David Don­abe­di­an. Camp­bell joined the com­pa­ny in 2016, serv­ing as SVP, R&D. Pri­or to hop­ping aboard the com­pa­ny, Camp­bell held roles at An­co­ra/Cor­den­Phar­ma, Sur­face Logix and In­smed.

→ To quote Tom Pet­ty, the wait­ing was the hard­est part for Aveo On­col­o­gy, but the wait is over af­ter the FDA gave its ap­proval to tivozanib, now mar­ket­ed as Fo­tiv­da, for re­lapsed or re­frac­to­ry ad­vanced re­nal cell car­ci­no­ma. Along with that news comes the pro­mo­tion of Mike Fer­ra­res­so to chief com­mer­cial of­fi­cer, who was pre­vi­ous­ly SVP, busi­ness an­a­lyt­ics and com­mer­cial op­er­a­tions. Tak­ing the same CCO post that CEO Michael Bai­ley held when he first joined AVEO, Fer­ra­res­so’s oth­er stops in­clude Ve­rastem and AM­AG Phar­ma­ceu­ti­cals.

Gre­go­ry Wein­hoff

Centes­sa Phar­ma­ceu­ti­cals — the group of 10 sub­sidiaries pulled to­geth­er by Medicxi’s Francesco De Ru­ber­tis that al­so hand­ed the CSO reins to ex-Op­er­a­tion Warp Speed chief Mon­cef Slaouihas tapped Gre­go­ry Wein­hoff as CFO. Wein­hoff co-found­ed and was CBO and CFO of Arvelle, which got the M&A wheels turn­ing in 2021 with An­geli­ni buy­ing out the com­pa­ny for $960 mil­lion. Ad­di­tion­al­ly, Wein­hoff was CFO at Ax­o­vant from 2015-19.

Centes­sa has al­so as­sem­bled a few lu­mi­nar­ies to serve on the board of di­rec­tors: Tesaro co-founder and ex-pres­i­dent Mary Lynne Hed­ley, for­mer FDA com­mis­sion­er Robert Califf and CRISPR Ther­a­peu­tics CEO Sam Kulka­rni were all named to the board Feb. 23.

Pe­ony Yu

→ Af­ter re­tir­ing from Fi­bro­Gen — which is once again in rox­adu­s­tat lim­bo fol­low­ing an­oth­er de­lay — in De­cem­ber, Pe­ony Yu is back on the CMO block with im­muno-on­col­o­gy play­er Apol­lomics start­ing this com­ing Tues­day. She re­places in­ter­im CMO Glenn Michel­son and spent 12 years with Fi­bro­Gen, get­ting pro­mot­ed to CMO in 2016. Else­where at Or­biMed-backed Apol­lomics, So­phie (Zhengjie) Sun has been named SVP, cor­po­rate de­vel­op­ment. Sun was VP and man­ag­ing di­rec­tor of Mer­ck KGaA’s In­no­va­tion Hub Chi­na and had served at the Ger­man phar­ma in var­i­ous posts since 2009.

In­ter­cept has sad­dled up to their reg­u­lar Peer Re­view barstool with the de­par­ture of CFO Sandip Ka­pa­dia. For those scor­ing at home, CEO Mark Pruzan­s­ki, CMO Ja­son Cam­pagna and now CFO Ka­pa­dia are all gone from the C-suite af­ter the FDA’s re­jec­tion of obeti­cholic acid in June, which prompt­ed a heat­ed re­sponse from Pruzan­s­ki at the time. The con­stant flux in In­ter­cept’s lead­er­ship con­tin­ued a few weeks ago with the ap­point­ment of chief com­mer­cial of­fi­cer Lin­da Richard­son, and now it’s Ka­pa­dia’s turn af­ter near­ly five years with the com­pa­ny. In the wake of Ka­pa­dia’s ex­it, In­ter­cept’s cor­po­rate con­troller Roc­co Venezia lands the dual roles of act­ing CFO and chief ac­count­ing of­fi­cer.

Ja­son Cam­pagna

→ One of those In­ter­cept de­fec­tors, Ja­son Cam­pagna, has of­fi­cial­ly moved on to be­come CMO of Q32 Bio, which net­ted $60 mil­lion in Se­ries B fund­ing in late Oc­to­ber as the biotech looks to strength­en its com­ple­ment drug pipeline. Cam­pagna, who start­ed out as In­ter­cept’s SVP and glob­al NASH lead in 2016 be­fore slid­ing in­to the CMO slot, was al­so an ex­ec with The Med­i­cines Com­pa­ny. Our Max Gel­man dis­cussed the cof­fee meet­ings Cam­pagna had with CEO Mike Brox­son lead­ing up to the ap­point­ment since they live in such close prox­im­i­ty — “We could prob­a­bly throw a rock at each oth­er’s hous­es,” Cam­pagna said.

Lu­ca Rastel­li has joined can­cer- and au­toim­mune dis­ease-fo­cused Ju­bi­lant Ther­a­peu­tics out of Bed­min­ster, NJ as CSO af­ter near­ly three years in the same po­si­tion at Kleo Phar­ma­ceu­ti­cals. The ex-EMD Serono staffer who led de­vel­op­ment of the ap­proved MET in­hibitor Tep­metko has al­so been VP, on­col­o­gy at BioX­cel.

→ Part­ing ways with Sanofi af­ter 19 years, Anne Da­gal­li­er has signed on to Paris-based mi­cro­bio­me biotech En­terome as CBO. Lead­ing up to this change in venue, Da­gal­li­er had been head of con­sumer health care al­liances and in-li­cens­es at Sanofi Glob­al Al­liances Man­age­ment. For a time she was al­so head of ex­ter­nal in­no­va­tion, in­fec­tious dis­eases in ad­di­tion to her var­ied strate­gic and BD roles at the phar­ma gi­ant.

Ed­uar­do Bruno Mar­tins

→ San Ma­teo, CA-based Sagimet Bio­sciences has reeled in Ed­uar­do Bruno Mar­tins as CMO. Most re­cent­ly, Mar­tins served as VP of clin­i­cal de­vel­op­ment at Ab­b­Vie. Pri­or to that, Mar­tins was VP of clin­i­cal de­vel­op­ment at Al­ler­gan. In ad­di­tion, Mar­tins has served in roles at Gilead, Genen­tech, Dy­navax Tech­nolo­gies and In­ter­mune among oth­ers.

→ Last week, Gainesville, FL biotech Cy­clo Ther­a­peu­tics reeled in ex-Ed­i­tas Med­i­cine CMO Ger­ald Cox as CMO. This week, the com­pa­ny has brought on Russ Belden as act­ing CCO. Belden jump-start­ed his ca­reer at Genen­tech’s SSF Com­mer­cial or­ga­ni­za­tion, spend­ing 16 years on board. Af­ter­wards, Belden be­came the founder, pres­i­dent and CEO of Bridge Con­sult­ing. In ad­di­tion, Belden cur­rent­ly serves as the iC­CO at three Phase III com­pa­nies.

Er­mi­um Ther­a­peu­tics — fo­cused on de­vel­op­ing ther­a­pies for au­to-im­mune dis­eases — has made a new ad­di­tion to its ex­ec­u­tive team with the ap­point­ment of An­negret Van der Aa as CSO and chief de­vel­op­ment of­fi­cer. Van der Aa brings ex­pe­ri­ence with her from her time at Gala­pa­gos, Inno­genet­ics, Ac­to­GeniX and OC­TIMET On­col­o­gy.

Teona John­son

→ Stock­holm-based Cal­lid­i­tas, “de­light­ed” with its strong Phase III da­ta for Ne­fe­con last fall to use CEO Renée Aguiar-Lu­can­der’s word, has hit a tri­fec­ta of ap­pointees for its US or­ga­ni­za­tion with War­ren Brooks (VP of US med­ical af­fairs), Teona John­son (head of US mar­ket­ing) and David Fer­raro (head of US sales). Brooks leaves Len Schleifer’s folks at Re­gen­eron af­ter 12 years at sev­er­al posts, most re­cent­ly as se­nior di­rec­tor, na­tion­al lead in im­munol­o­gy in med­ical af­fairs. Since 2010, John­son held mul­ti­ple roles at Pfiz­er, break­ing from the phar­ma gi­ant af­ter lead­ing the mar­ket­ing strat­e­gy for Ibrance as glob­al com­mer­cial di­rec­tor. And Fer­raro hails from Ky­owa Kirin, where he served as na­tion­al sales di­rec­tor for the on­col­o­gy/rare dis­ease busi­ness unit.

Car­o­line Kurtz

Syn­log­ic has made some changes in its lead­er­ship team with the pro­mo­tions of Car­o­line Kurtz to chief de­vel­op­ment of­fi­cer and pro­mo­tion of Daniel Rosan to SVP and head of fi­nance. Kurtz joined Syn­log­ic in Oc­to­ber 2016. Pri­or to hop­ping aboard the com­pa­ny, Kurtz was at Iron­wood Phar­ma­ceu­ti­cals. Mean­while, Rosan joined Syn­log­ic from Bio­gen, where he held a six-year stint.

In ad­di­tion to the two pro­mo­tions, the Cam­bridge, MA-based com­pa­ny has ap­point­ed Jamie Austin as VP and in­com­ing head of reg­u­la­to­ry af­fairs. Austin comes aboard with ex­pe­ri­ence from her time at As­traZeneca, Ab­b­Vie and blue­bird bio.

→ For­mer as­sis­tant White House coun­sel Alexan­der Nguyen has stepped in as gen­er­al coun­sel at Uni­ty Biotech­nol­o­gy, which has seen its share of trou­bles and high-pro­file ex­its. Nguyen, who was on the White House le­gal team from 2010-11, has ex­pe­ri­ence at three sep­a­rate Vants to his cred­it: first as head of le­gal at Ax­o­vant, then as head of com­pli­ance at Roivant, and fi­nal­ly as gen­er­al coun­sel at Aly­vant.

As­cen­sion Health­care — fo­cused on ther­a­pies for he­mo­phil­ia and os­teoarthri­tis — has named Ben Ver­tannes as head of glob­al mar­ket­ing. Ver­tannes joins the com­pa­ny with ex­pe­ri­ence from his roles at Bay­er, No­var­tis, Wella and Pfiz­er.

Bar­bara Kosacz

Bar­bara Kosacz has made her way to the board of di­rec­tors at Leen Kawas-led Athi­ra Phar­ma not long af­ter be­com­ing a board mem­ber at Ar­se­nal­Bio. Peer Re­view cov­ered Kosacz’s ap­point­ment as COO and gen­er­al coun­sel of Kro­nos Bio last sum­mer.

→ Stan­ford Uni­ver­si­ty School of Med­i­cine pro­fes­sor (and not­ed Eliz­a­beth Holmes skep­tic) Phyl­lis Gard­ner has jumped on to the board of di­rec­tors at MiMedx. Since 2006, Gard­ner has al­so been a board mem­ber at Re­vance.

Ner­is­sa Kre­her

→ Sil­i­con Val­ley-based Re­zo­lute, work­ing on its lead drug RZ358 to treat con­gen­i­tal hy­per­in­sulin­ism, has se­lect­ed Vlad Hogen­huis and Ner­is­sa Kre­her for its board of di­rec­tors. Hogen­huis, a GSK vet, is the ex-COO of Ul­tragenyx, while Kre­her was just ap­point­ed CMO of En­tra­da Ther­a­peu­tics a few months ago.

Su­san Wind­ham-Ban­nis­ter

→ On clin­i­cal hold with its knee car­ti­lage re­gen­er­a­tion ther­a­py, His­to­gen out of San Diego has ap­point­ed Su­san Wind­ham-Ban­nis­ter to the board of di­rec­tors. Wind­ham-Ban­nis­ter, the pres­i­dent and CEO of Bio­med­ical Growth Strate­gies, is al­so the found­ing pres­i­dent and CEO of the Mass­a­chu­setts Life Sci­ences Cen­ter.

→ Lon­don-based Free­line Ther­a­peu­tics, which hit the pause but­ton last month on its gene ther­a­py tri­al, has brought in Col­in Love to be a mem­ber of the board of di­rec­tors. The Am­gen vet co-found­ed and is COO of Replimune.

Eliz­a­beth Garo­fa­lo

Tim Wal­bert-chaired gene ex­pres­sion biotech Ex­i­cure has wel­comed Eliz­a­beth Garo­fa­lo and An­drew Sas­sine to the board of di­rec­tors fol­low­ing the ap­point­ment of James Su­lat last month. Garo­fa­lo — who’s on the board at Aca­dia — was No­var­tis’ SVP and glob­al head of clin­i­cal de­vel­op­ment, and Sas­sine is CFO at Arc­turus.

Un­learn, de­vel­op­er of the first ma­chine-learn­ing plat­form that cre­ates Dig­i­tal Twins used to en­able small­er, faster clin­i­cal tri­als, has pulled in Ann E. Tay­lor to its board of di­rec­tors. Tay­lor cur­rent­ly serves as CMO of As­traZeneca. Pri­or to her role at As­traZeneca, Tay­lor was VP, glob­al clin­i­cal de­vel­op­ment at Med­im­mune and had stints at No­var­tis and Pfiz­er.

An­drew Sin­clair now has a seat re­served on the board of di­rec­tors at Adicet Bio. Sin­clair is a part­ner and port­fo­lio man­ag­er at Abing­worth and is in his 13th year with the group.

→ De­vel­op­ing ther­a­pies to re­pair dam­aged tis­sues, Pitts­burgh-based Noveome Ther­a­peu­tics has cho­sen Christo­pher Velis to join its board of di­rec­tors. Velis is the co-founder and ex­ec­u­tive chair­man of Mi­ra­ki In­no­va­tion, BOA Bio­med­ical and Arc­tic Fox Bio­med­ical. In ad­di­tion, Velis is the co-founder of Au­ris Health.

Dana Rol­li­son

NanoS­tring Tech­nolo­gies has made two new board ap­point­ments with the ad­di­tions of Dana Rol­li­son and Janet George. Rol­li­son cur­rent­ly serves as VP, chief da­ta of­fi­cer and as­so­ciate cen­ter di­rec­tor of da­ta sci­ence for the Mof­fitt Can­cer Cen­ter. Mean­while, George is the VP of au­tonomous en­ter­prise, ad­vanced an­a­lyt­ics with ma­chine learn­ing and ar­ti­fi­cial in­tel­li­gence at Or­a­cle. Pri­or to Or­a­cle, George has held stints at San­disk, Ya­hoo, eBay and Ap­ple among oth­ers.

→ La Jol­la, CA-based Arte­lo Bio­sciences has added Tama­ra Sey­mour to its board of di­rec­tors. Sey­mour pre­vi­ous­ly served in roles at Im­mu­nic, Sig­nal Ge­net­ics, De­loitte and Bea­con Dis­cov­ery, among oth­ers.

→ Ad­vanced can­cers-fo­cused Pen­rose Ther­a­peuTx has added mi­to­chon­dr­i­al re­searcher Navdeep Chan­del to its sci­en­tif­ic ad­vi­so­ry board. Chan­del is pro­fes­sor of med­i­cine bio­chem­istry and mol­e­c­u­lar ge­net­ics at North­west­ern Uni­ver­si­ty’s Fein­berg School of Med­i­cine.

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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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.

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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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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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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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.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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