Zosano Phar­ma CEO pass­es ba­ton down to suc­ces­sor; James Sapirstein takes the helm at Azur­Rx

→ Two years af­ter Zosano Phar­ma re­port­ed pos­i­tive Phase III da­ta for its mi­cronee­dle patch sys­tem for de­liv­er­ing an old mi­graine drug — set­ting up a cam­paign to file an NDA — the com­pa­ny has brought on Steven Lo to the helm as pres­i­dent and CEO. Lo will be suc­ceed­ing John Walk­er, who is re­tir­ing af­ter 48 years in the health­care in­dus­try. Walk­er will re­main as the chair­man of the board of di­rec­tors. Lo most re­cent­ly served as the CCO at Puma Biotech­nol­o­gy, where he helped with the launch of the com­pa­ny’s first prod­uct, Ner­l­ynx — whose Q1 sales fell un­com­fort­ably short of Wall Street es­ti­mates. In ad­di­tion, Lo was the CCO of Cor­cept Ther­a­peu­tics, where he led the es­tab­lish­ment of their first prod­uct, Ko­r­lym, a treat­ment for Cush­ing’s syn­drome. Ear­li­er in his ca­reer, Lo held stints at Genen­tech and As­traZeneca. Lo’s ap­point­ment comes a few weeks af­ter the com­pa­ny wel­comed Dushyant Pathak as SVP of busi­ness de­vel­op­ment. 

James Sapirstein Busi­ness Wire

→ Gas­troin­testi­nal dis­ease-fo­cused Azur­Rx Bio­Phar­ma has a new face run­ning the com­pa­ny af­ter CEO Thi­js Spoor an­nounced his res­ig­na­tion. James Sapirstein is join­ing the com­pa­ny as the new CEO af­ter a stint in the same po­si­tion at Con­traVir Phar­ma­ceu­ti­cals (now He­p­i­on Phar­ma­ceu­ti­cals). Sapirstein has par­tic­i­pat­ed in 23 prod­uct launch­es and he’ll bring this ex­pe­ri­ence to help with the com­pa­ny’s lead prod­uct can­di­date, MS1819-SD — a re­com­bi­nant li­pase for ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy. Pri­or to Con­traVir, Sapirstein served as the CEO of Alli­qua Ther­a­peu­tics, the found­ing CEO of To­bi­ra Ther­a­peu­tics and as EVP, meta­bol­ic en­docrinol­o­gy at Serono Lab­o­ra­to­ries. His oth­er stints in­clude roles at Gilead Sci­ences and Bris­tol-My­ers Squibb. Spoor will re­main on the com­pa­ny’s board of di­rec­tors. 

CRO Pharm-Olam has tapped Robert Davie to suc­ceed David Grange — who has been with the com­pa­ny since April 2017 — as CEO. Grange will re­main a di­rec­tor and vice chair­man of the com­pa­ny’s board of di­rec­tors. Davie brings ex­pe­ri­ence from his time as vice pres­i­dent and gen­er­al man­ag­er, glob­al clin­i­cal de­vel­op­ment at Co­v­ance, where he man­aged the over­sight of clin­i­cal op­er­a­tions in 60 coun­tries with more than 6,000 em­ploy­ees un­der his guid­ance. Pri­or to his time at Co­v­ance, Davie served at Proc­ter & Gam­ble in OTC Health­care. Be­fore jump­ing in­to biotech, Davie fo­cused on the study of GI phys­i­ol­o­gy, in­clud­ing met­al ion trans­port and the trans­port of bile acids in pa­tients with in­flam­ma­to­ry bow­el dis­ease. 

→ At the same time that it pre­sent­ed new da­ta for two of its clin­i­cal stud­ies, Pre­ci­sion Di­a­betes has tapped Er­ic But­ton to the helm as CEO. But­ton is the cur­rent pres­i­dent of Neo­Mark Ven­tures and has pre­vi­ous­ly served as head of di­ag­nos­tics at Metabolon. Some of his oth­er stints in­clude SVP of new prod­uct strat­e­gy at True Health Di­ag­nos­tics and as pres­i­dent and founder of both Gly­co­Mark and Am­plis­tar.

→ Can­cer test­ing start­up Grail — which had a top ex­ec change up, when then CEO Jen­nifer Cook stepped down for fam­i­ly health rea­sons and left the com­pa­ny in the hands of Hans Bish­ophas named Matthew Young as COO and CFO. Young joins the com­pa­ny from Jazz Phar­ma­ceu­ti­cals, where he served as EVP and CFO. Pri­or to his time at Jazz, Young hed po­si­tions at Bar­clays Cap­i­tal, Cit­i­group Glob­al Mar­kets and Lehman Broth­ers

AEON Bio­phar­ma — a com­pa­ny fo­cused on the ther­a­peu­tic tox­in mar­ket — has re­cruit­ed Chris Carr as CFO and Scott Akamine as gen­er­al coun­sel. Carr most re­cent­ly served as CFO, EVP of fi­nance and IT and board mem­ber of Den­dreon Phar­ma­ceu­ti­cals. Pri­or to that, he held stints at Ab­bott Lab­o­ra­to­ries, PerkinElmer and Gen­zyme. Akamine jumps over af­ter a stint as vice pres­i­dent and as­so­ciate gen­er­al coun­sel at Core­L­og­ic. Be­fore that, Akamine worked at In­ci­pio, Al­ler­gan and the law firm Lath­am & Watkins

→ Oph­thalmic phar­ma­ceu­ti­cal com­pa­ny Aerie Phar­ma­ceu­ti­cals — fo­cused on the treat­ment of pa­tients with open-an­gle glau­co­ma and oth­er reti­nal dis­eases — has brought a new face aboard with the ap­point­ment of Char­lene Davis as vice pres­i­dent and chief com­pli­ance of­fi­cer. Davis makes the jump af­ter a stint at Sun Phar­ma­ceu­ti­cal In­dus­tries

Amer­i­can BriV­i­sion — fo­cused on the de­vel­op­ment of ther­a­pies in on­col­o­gy/hema­tol­ogy, CNS and oph­thal­mol­o­gy — has wel­comed Chih­liang “Andy” An as CFO. An joins from a stint as man­ag­ing di­rec­tor of the in­vest­ment team at Yinyai In­vest­ment in Hong Kong. Pri­or to his time at Yinyai, An served as a se­nior di­rec­tor of sales and op­er­a­tions at Go­ertek and as a con­sul­tant and di­rec­tor of fi­nance at BioKey. In ad­di­tion, he’s al­so held stint at Flex­tron­ics, Chardan Cap­i­tal and Op­to­plex

An­ish Suri Cue

Cue Bio­phar­ma — work­ing on in­jectable bi­o­log­ics to se­lec­tive­ly en­gage and mod­u­late tar­get­ed T cells with­in the body — has named An­ish Suri pres­i­dent in ad­di­tion to his cur­rent role as CSO of the com­pa­ny. Pri­or to join­ing the com­pa­ny in Ju­ly 2018, Suri held stints at Janssen Phar­ma­ceu­ti­cal, Bris­tol-My­ers Squibb and was as­sis­tant pro­fes­sor of pathol­o­gy and im­munol­o­gy at Wash­ing­ton Uni­ver­si­ty School of Med­i­cine. In ad­di­tion to Suri’s ap­point­ment, the com­pa­ny plans to bring in a num­ber of new hires through 2020 in light of the re­cent clear­ance of the com­pa­ny’s lead drug can­di­date, CUE-101, in­to clin­i­cal de­vel­op­ment.

An­gela Jus­tice TCR²

→ Can­cer-fo­cused TCR² Ther­a­peu­tics has wel­comed An­gela Jus­tice to the com­pa­ny as chief peo­ple of­fi­cer. Jus­tice hails from Surgery Part­ners, where she served as EVP and chief hu­man re­sources of­fi­cer. Pri­or to that, she served as se­nior di­rec­tor of glob­al med­ical af­fairs, as well as the chief learn­ing of­fi­cer at Bio­gen, where she cre­at­ed and led a cen­tral­ized learn­ing or­ga­ni­za­tion sup­port­ing 14,000 peo­ple across all de­part­ments and ge­o­gra­phies. Her oth­er stints in­clude roles at EMD Serono, the Na­tion­al MS So­ci­ety and as a man­age­ment con­sul­tant at McK­in­sey & Com­pa­ny.

Tan­isha Co­ri­na

→ Af­ter an­a­lysts were blind­sided last month with the sur­prise ex­it of Alex­ion‘s CFO, Paul Clan­cy — who was be­ing re­placed by Arad­hana Sarin as strat­e­gy and busi­ness chief — the com­pa­ny has brought on Tan­isha Cari­no as EVP and chief cor­po­rate af­fairs of­fi­cer. In ad­di­tion, she will serve on the com­pa­ny’s ex­ec­u­tive com­mit­tee. Pri­or to jump­ing on board Alex­ion, Cari­no served as the ex­ec­u­tive di­rec­tor of Faster­Cures, a cen­ter of the Milken In­sti­tute. Be­fore that, she served in roles at GSK and Avalere Health.

→ Toron­to-based Cycli­ca — of­fer­ing a drug dis­cov­ery plat­form fo­cused on polyphar­ma­col­o­gy — has an­nounced the ap­point­ment of Vern De Bi­asi as VP, glob­al head of strate­gic part­ner­ships. Pri­or to jump­ing aboard Cycli­ca, De Bi­asi held var­i­ous roles at GSK, in­clud­ing head of emerg­ing plat­forms, head of dig­i­tal da­ta and an­a­lyt­ics and head of plat­form tech­nol­o­gy and sci­ence at GSK R&D, Asia in Shang­hai. 

→ Lon­don-based cell ther­a­py play­er Au­to­lus Ther­a­peu­tics has made changes to its lead­er­ship team. The com­pa­ny an­nounced that Jim Faulkn­er, SVP, head of prod­uct de­liv­ery, and Neil Bell, SVP, head of clin­i­cal op­er­a­tions, will be hit­ting the ex­it. The two will be suc­ceed­ed by David Brochu and Vishal Mehta, re­spec­tive­ly. Brochu pre­vi­ous­ly held the po­si­tion of vice pres­i­dent of tech­ni­cal op­er­a­tions at Au­to­lus and pri­or to join­ing the com­pa­ny held po­si­tions at Kedri­on, Tale­cris Bio­Ther­a­peu­tics (for­mer­ly Bay­er Health­care) and Bay­er. Mehta joined Au­to­lus at the be­gin­ning of the year from Cel­gene, where he led the plan­ning and ex­e­cu­tion of mul­ti­ple clin­i­cal stud­ies for CAR T prod­ucts in B cell ma­lig­nan­cies and mul­ti­ple myelo­ma. Pri­or to Cel­gene, Mehta had stints at No­var­tis and ICON.

→ The med­ical der­ma­tol­ogy com­pa­ny Ver­ri­ca Phar­ma­ceu­ti­cals has ap­point­ed Eu­gene Scav­ola as EVP, tech­ni­cal op­er­a­tions. Most re­cent­ly, Scav­ola was a man­ag­ing part­ner at PBM Cap­i­tal Group. In ad­di­tion, Scav­ola has served in var­i­ous po­si­tions at Wyeth/Pfiz­er.

Karl Brad­shaw Metabolon

Metabolon — fo­cused on, you guessed it, metabolomics — has ap­point­ed Karl Brad­shaw as VP of bio­phar­ma strat­e­gy and part­ner­ing, who joins the com­pa­ny af­ter a stint as se­nior di­rec­tor of cor­po­rate strat­e­gy and de­vel­op­ment at As­traZeneca. Pri­or to his time there, Brad­shaw was vice pres­i­dent of eq­ui­ty and re­search at Mor­gan Stan­ley

Flem­ming Orn­skov

→ A week pri­or to win­ning FDA ap­proval for its top­i­cal retinoid cream, tri­farotene, in the use of ac­ne — dif­ferin mak­er Gal­der­ma made some new ad­di­tions to its ex­ec­u­tive team with the ap­point­ments of Shire vets Flem­ming Orn­skov as CEO and Thomas Dit­trich as CFO. Orn­skov as­sumes the po­si­tion as CEO from Stu­art Raet­z­man, who is mov­ing to a po­si­tion on the com­pa­ny’s board. Dur­ing his time at Shire, Orn­skov helped grow the com­pa­ny from a $4 bil­lion rev­enue busi­ness to $15 bil­lion in five years, be­fore the com­pa­ny was ac­quired by Take­da. Dit­trich held the same po­si­tion of CFO at Shire. In ad­di­tion to the new ex­ecs, the com­pa­ny has wel­comed for­mer CEO of No­var­tis Thomas Ebel­ing as chair­man of its board of di­rec­tors and for­mer CEO of Avon Prod­ucts and for­mer vice chair­man of John­son & John­son, Sheri Mc­Coy as di­rec­tor of the com­pa­ny. 

→  In the storm of rapid ex­its of its top ex­ecs, Gilead’s CEO Daniel O’Day has brought on Genen­tech SVP of ear­ly clin­i­cal de­vel­op­ment, Mer­dad Parsey, on board as the com­pa­ny’s CMO. Parsey made his way to Genen­tech af­ter a de­tour as CEO of NASH drug de­vel­op­er 3V Bio­sciences (now known as Sagimet) for five years. Gilead has seen a clean sweep of its top ranks since CEO John Mil­li­gan stepped out along­side chair­man John Mar­tin, and not long af­ter oth­ers fol­lowed suit — CSO John McHutchi­son left for a new po­si­tion of CEO at As­sem­bly Bio­sciences, CMO An­drew Cheng left for the helm at Akero and re­search chief Nor­bert Bischof­berg­er left to run his own start­up

Han­dan He

→ Hong Kong-list­ed, Hangzhou-based As­cle­tis has wooed an­oth­er top phar­ma ex­ec from the US to Chi­na as it gets ready to show that its R&D team has what it takes to come up with some first-in-class drugs. In tak­ing up the CSO role Han­dan He is leav­ing be­hind a 22-year stint at No­var­tis, where her last ti­tle was glob­al head of com­pu­ta­tion­al, bio­phar­ma­ceu­tics and trans­la­tion­al PK/PD. Her ar­rival marks an­oth­er big get for CEO Jinzi Wu, who ear­li­er this year re­cruit­ed Mer­ck’s top drug de­vel­op­er in Chi­na as As­cle­tis’ CMO. But health and fam­i­ly con­cerns cut Zhengqing Li’s tenure short, forc­ing him to de­part af­ter on­ly five months. Days ago CFO Lin­di Tan al­so hand­ed in her pa­pers. As­cle­tis is known do­mes­ti­cal­ly for de­vel­op­ing and com­mer­cial­iz­ing Chi­na’s first home-cul­ti­vat­ed he­pati­tis C drug — with some help from Roche — but has made a point to be­come a glob­al play­er, not just in the an­tivi­ral space but al­so can­cer and liv­er dis­eases.

→ As Bio­Marin shoots for the first-ever ap­proval of a he­mo­phil­ia gene ther­a­py — and the multi­bil­lion-dol­lar rev­enue ex­pect­ed to fol­low — the com­pa­ny is pro­mot­ing CSO Lon Car­don to a po­si­tion where he can help sketch the next ren­di­tion of its rare dis­ease port­fo­lio. In the new­ly cre­at­ed role of chief sci­en­tif­ic strate­gic of­fi­cer, Car­don will look be­yond the re­search work that he’s been lead­ing for the past two years to “lead cross func­tion­al ac­tiv­i­ties to build our lead­er­ship po­si­tion in pre­ci­sion med­i­cine,” ac­cord­ing to Bio­Marin. Car­don held a 9-year tenure at GSK where he was the SVP of al­ter­na­tive dis­cov­ery and de­vel­op­ment — lin­ing up a $495 mil­lion al­liance with Aval­on Ven­tures to bankroll some star­tups and buy them out if the sci­ence stands up to due dili­gence.  

Bolt Bio­ther­a­peu­ticswho wel­comed their new CEO Randy Schatz­man last month — has made three ad­di­tions to its sci­en­tif­ic board of di­rec­tors: UCSF pro­fes­sor Lawrence Fong, as­so­ciate di­rec­tor of Yale Can­cer Cen­ter Roy Herb­st and Lip­i­tor in­ven­tor Bruce Roth

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”