Randy Schatz­man jumps to the helm of an­oth­er start-up; No­vo Nordisk vet lands top post at Macrophage Phar­ma

In biotech, long-term sur­vival in the ex­ec­u­tive ranks can de­pend a lot on the qual­i­ty of your con­nec­tions in the ven­ture/in­vest­ing side of the busi­ness.

Randy Schatz­man Bolt Bio­ther­a­peu­tics

So when Randy Schatz­man ex­it­ed Alder af­ter tak­ing the com­pa­ny from con­cep­tion to the thresh­old of a like­ly ap­proval for a new mi­graine ther­a­py, it was his re­la­tion­ship with long­time back­ers that led him to his new job as CEO of Bolt Bio­ther­a­peu­tics, an­nounced this week.

Con­nec­tions at No­vo and an­oth­er in­vestor asked him to check out the Red­wood City, CA start­up, which has been work­ing on what they call “im­mune-stim­u­lat­ing an­ti­body con­ju­gates” to turn cold tu­mors hot — a pop­u­lar theme in the on­col­o­gy field.

He was im­pressed with the tech­nol­o­gy and the team of about 35, which he ex­pects to see dou­ble in size in the next 18 to 24 months. But the big move will be the shift to the clin­ic in Q1 2020, which is right around the cor­ner now. Fund­ing as al­ways will be a key con­sid­er­a­tion for the start­up, but Schatz­man al­ready knows just how com­mit­ted the syn­di­cate is — which helps con­sid­er­ably.

“I think I got some in­sights, build­ing a com­pa­ny from scratch to the com­mer­cial en­vi­ron­ment,” Schatz­man tells me. So he’ll stay fo­cused on the fun­da­men­tals: tech and clin­i­cal de­vel­op­ment plans, re­cruit­ment, fi­nanc­ing and mak­ing sure he has a rock-sol­id board back­ing him.

Schatz­man’s ad­vice for oth­er CEOs: Hav­ing a “board that is row­ing in the same di­rec­tion,” he says. 

He’s grab­bing an oar to help set the tem­po. — John Car­roll

Michael Slater Syn­log­ic

→ A few months af­ter Syn­log­ic — a pi­o­neer in reengi­neer­ing non-path­o­gen­ic bac­te­ria in­to med­i­cines — inked a col­lab­o­ra­tion with Gink­go Bioworks, it’s ap­point­ed Richard Riese as CMO and Michael Slater as head of reg­u­la­to­ry af­fairs. Riese most re­cent­ly served as the vice pres­i­dent, clin­i­cal de­vel­op­ment at Al­ny­lam and was pre­vi­ous­ly at Alex­ion. Slater was the head of reg­u­la­to­ry af­fairs and, lat­er, de­vel­op­ment op­er­a­tions at Mer­ri­mack Phar­ma­ceu­ti­cals, where he helped lead the com­pa­ny to the 2015 US ap­proval of Onivyde for the treat­ment of metasta­t­ic pan­cre­at­ic can­cer. Slater has held var­i­ous stints, in­clud­ing at Mil­len­ni­um Phar­ma­ceu­ti­cals, Ani­ka Ther­a­peu­tics and Bio­gen. In ad­di­tion, the com­pa­ny an­nounced that CFO Todd She­gog will be hit­ting the ex­it to pur­sue oth­er op­por­tu­ni­ties. 

Richard Riese Syn­log­ic

→ Paris-based Step Phar­ma — an au­toim­mune-fo­cused biotech on the cusp of ush­er­ing its first oral nu­cleotide syn­the­sis in­hibitor tar­get­ing CTPS1 to the clin­ic — has wooed for­mer Zealand Phar­ma CSO An­drew Park­er as CEO, suc­ceed­ing Ge­of­froy de Rib­ains. Park­er an­nounced his res­ig­na­tion from Zealand in ear­ly Au­gust af­ter a three-year stint with the com­pa­ny. Dur­ing his time at Zealand, Park­er helped as­sem­ble a pre­clin­i­cal pipeline of ion chan­nel block­ers, GLP-1 as­sets and a com­ple­ment C3 in­hibitor. Pri­or to that, he was gen­er­al part­ner and sci­en­tif­ic di­rec­tor of life sci­ences in­vest­ment com­pa­ny Eclo­sion2 & Cie SCPC. Park­er’s pre­vi­ous stints in­clude roles at As­traZeneca, John­son & John­son and Op­sona Ther­a­peu­tics

An­drew Park­er

“The com­pa­ny has made sig­nif­i­cant progress in op­ti­miz­ing se­lec­tive CTPS1 in­hibitors and ex­plor­ing the role of CTPS1 in au­toim­mune dis­eases. My role will be to de­sign and im­ple­ment a plan to trans­late the phe­nom­e­nal sci­en­tif­ic progress made to date in­to a clin­i­cal pipeline,” not­ed Park­er.

No­vo Nordisk vet Søren Bre­gen­holt is tak­ing up his first CEO post at Macrophage Phar­ma in Eng­land to steer the start­up through ear­ly ef­forts of ap­ply­ing its Es­terase Mo­tif Tech­nol­o­gy. CRT Pi­o­neer Fund, Agla­ia On­col­o­gy Fund II, No­vo Hold­ings and M Ven­tures had pooled to­geth­er £9 mil­lion back in 2017 for the ESM plat­form, which gen­er­ates small mol­e­cule drugs that in­duce tran­scrip­tion­al re­pro­gram­ming of mono­cytes and macrophages. The lead pro­gram tar­gets p38 MAPK. While Bre­gen­holt brings fresh ex­pe­ri­ence in im­muno-on­col­o­gy from a brief CBO stint at IO Biotech, he is al­so talked with un­lock­ing ESM’s po­ten­tial in oth­er dis­eases.

Søren Bre­gen­holt Macrophage

→ Ready to stake a bold claim in the nascent field of RNA mod­i­fi­ca­tion, Ac­cent Ther­a­peu­tics has wooed sea­soned deal­mak­er Shak­ti Narayan to be­come its CEO. Narayan, who most re­cent­ly served as CBO of Tan­go Ther­a­peu­tics, was cred­it­ed for lead­ing the biotech’s “trans­for­ma­tion­al” col­lab­o­ra­tion with Gilead, which was worth up to $1.7 bil­lion. Hav­ing spe­cial­ized in on­col­o­gy busi­ness de­vel­op­ment from Genen­tech to J&J, he will now team up with Ac­cent pres­i­dent and CSO Robert Copeland in pluck­ing the most promis­ing in­hibito­ry small mol­e­cule drugs (block­ing RNA-mod­i­fy­ing en­zymes) in their dis­cov­ery pipeline.

→ Months af­ter Night­star’s $800 mil­lion sale to Bio­gen, Ak­ou­os has scooped Gre­go­ry Robin­son as CSO, lever­ag­ing his ex­per­tise in both gene ther­a­py and rare dis­ease trans­la­tion­al re­search. While Robin­son had fo­cused on reti­nal dis­or­ders at Night­star (and CNS dis­eases be­fore that at Ag­ilis Bio­ther­a­peu­tic), he will now turn his at­ten­tion to sen­sorineur­al hear­ing loss. Al­so join­ing the C-suite is Michael McKen­na, a co-founder of Ak­ou­os, who’s ex­pand­ing his role to full-time CMO. A neu­ro­to­log­ic sur­geon at Mass­a­chu­setts Eye and Ear, McKen­na con­tributed years of re­search on in­ner ear drug de­liv­ery that was key to Ak­ou­os’ cre­ation.

Si­mon Rus­sell Ome­icos

→ Ger­man car­dio­vas­cu­lar and oph­thal­mol­o­gy biotech Ome­icos has named Si­mon Rus­sell chief busi­ness of­fi­cer as it ap­proach­es clin­i­cal proof-of-con­cept and dose con­fir­ma­tion for its atri­al fib­ril­la­tion pro­gram, OMT-28. Rus­sell spent the ear­li­er years of his ca­reer climb­ing the ranks at As­traZeneca and No­var­tis, end­ing as glob­al com­mer­cial leader for the Swiss phar­ma gi­ant’s ill-fat­ed canakinum­ab. He has since made the trek to biotech and is now an en­tre­pre­neur in res­i­dence at the Basel Area ac­cel­er­a­tor Base­Launch, co-found­ing his own com­pa­ny just weeks be­fore join­ing Ome­icos in Berlin. “Ome­icos has a very promis­ing ther­a­peu­tic plat­form tar­get­ing one of na­ture’s most im­por­tant cell-pro­tec­tive path­ways,” Rus­sell said of its syn­thet­ic epoxy eicosanoid analogs.

James Mack­ay has wooed a for­mer col­league from Ardea Bio­sciences to help ex­pand the clin­i­cal port­fo­lio of his new start­up, Aris­tea. Ni­har Bhak­ta jumps to the CMO po­si­tion from Gos­samer Bio, where he was a project team leader. At San Diego-based Aris­tea he will keep a laser fo­cus on in­flam­ma­to­ry dis­eases, start­ing with a lead drug from As­traZeneca cur­rent­ly in Phase II. His pri­or ex­pe­ri­ence spans Roche and Bris­tol-My­ers Squibb.

→ An­ti­calin pro­tein-based drugs fo­cused Pieris Phar­ma­ceu­ti­cals had some change-ups to its lead­er­ship team with the ad­di­tion of Hit­to Kauf­mann as SVP and CSO and the an­nounce­ment of the de­par­ture of Al­lan Reine, SVP and CFO. In this new role, Kauf­mann will be re­spon­si­ble for the com­pa­ny’s drug dis­cov­ery, pro­tein en­gi­neer­ing and bio­man­u­fac­tur­ing ac­tiv­i­ties, while over­see­ing al­liance man­age­ment and serv­ing as site head for its Ger­man R&D fa­cil­i­ty. Kauf­mann held a stint at Sanofi be­fore hop­ping over to the Boston, Mass­a­chu­setts-based com­pa­ny. His pri­or ex­pe­ri­ence spans roles at Boehringer In­gel­heim and at the Wal­ter and Eliza Hall In­sti­tute in Mel­bourne. Pieris in­tends to ini­ti­ate a search for a new CFO as Reine will be pur­su­ing an­oth­er busi­ness op­por­tu­ni­ty. Up­on Reine’s res­ig­na­tion, Tom Bu­res, the com­pa­ny’s vice pres­i­dent of fi­nance, will serve as trea­sur­er and prin­ci­pal fi­nan­cial and ac­count­ing of­fi­cer.

Ab­Cellera has ex­pand­ed its ex­ec­u­tive team with the ad­di­tions of An­drew Booth as CFO and Tryn Sti­mart as gen­er­al coun­sel. Booth makes the jump from the com­pa­ny’s board of di­rec­tors and brings ex­pe­ri­ence to the role from his pre­vi­ous stint at STEM­CELL Tech­nolo­gies as vice pres­i­dent of in­stru­men­ta­tion, CFO and CMO. Sti­mart draws from ex­pe­ri­ence from his roles at Gib­bons PC, Finnegan, Coo­ley and Womble Bond Dick­in­son, where he has rep­re­sent­ed clients from Gilead, Take­da, Ge­vo, Sunovion and Ap­tal­is

Gil McVean Ge­nomics

→ Da­ta sci­ence com­pa­ny Ge­nomics — which was found­ed in 2014 by four pro­fes­sors out of the Uni­ver­si­ty of Ox­ford — has brought on one of its founders, pro­fes­sor of sta­tis­ti­cal ge­net­ics Gil McVean, as chief in­for­ma­tion of­fi­cer of the com­pa­ny. McVean is a found­ing di­rec­tor of the Big Da­ta In­sti­tute (BDI) and brings ex­pe­ri­ence from his time as head of bioin­for­mat­ics and sta­tis­ti­cal ge­net­ics at Ox­ford’s Well­come Cen­tre for Hu­man Ge­net­ics to the ta­ble. 

→ Af­ter bank­ing €12M to de­vel­op a drug for mul­ti­ple sys­tem at­ro­phy (MSA) — tar­get­ing tox­ic pro­tein ag­gre­ga­tion — in June, Ger­man biotech MODAG has ap­point­ed Jo­hannes Levin as CMO. Levin brings ex­pe­ri­ence in MSA along with a back­ground in pro­tein ag­gre­ga­tion. He re­cent­ly led a clin­i­cal MSA study with pro­fes­sor Armin Giese, CSO of MODAG — the find­ings were pub­lished in The Lancet Neu­rol­o­gy. In his new role, Levin will be re­spon­si­ble for ad­vanc­ing the com­pa­ny’s lead can­di­date, an­le138b, in­to the clin­ic.

East­Gate Biotech has en­list­ed Bill Aba­jian to over­see the li­cens­ing and mar­ket­ing of their liq­uid in­sulin mouth rinse so­lu­tion for type 2 di­a­betes as COO. Aba­jian, who’s pre­vi­ous­ly helped Generex com­mer­cial­ize an oral in­sulin spray in de­vel­op­ing coun­tries, will con­tin­ue to fo­cus on that part of the world. “We are on the cusp of ma­jor li­cens­ing ini­tia­tives and the com­pa­ny needs to be stream­lined and fo­cused to max­i­mize share­hold­er val­ue,” he said, adding about East­Gate’s pink sheet stock: “The mar­ket re­ac­tion to our fun­da­men­tal sto­ry has been ex­treme­ly dis­ap­point­ing as share­hold­ers choose to fo­cus on the struc­tur­al risks of di­lu­tion in­stead of the po­ten­tial of the tech­nol­o­gy. We are about to change the par­a­digm on how a small biotech brings drugs to mar­ket.”

Ter­ry-Ann Bur­rell has hopped over to Beam Ther­a­peu­tics — a com­pa­ny found­ed by CRISPR trail­blaz­ers David Liu, Feng Zhang and J Kei­th Joung — af­ter a stint as man­ag­ing di­rec­tor at JP Mor­gan. Dur­ing her time at JP Mor­gan, Bur­rell helped ex­e­cute over $10 bil­lion in eq­ui­ty and eq­ui­ty-linked fi­nanc­ings and more than $50 bil­lion in M&A trans­ac­tions. Pri­or to that, Bur­rell worked in eq­ui­ty re­search at Cit­i­group, cov­er­ing spe­cial­ty phar­ma­ceu­ti­cals and gener­ics. 

Juha Lau­ren Kally­ope

Jernej Godec has joined VC firm At­las Ven­ture. Pri­or to hop­ping on board to At­las, Godec was the se­nior as­so­ciate at Ap­ple Tree Part­ners, in­volved in build­ing El­star Ther­a­peu­tics, an ATP-found­ed com­pa­ny de­vel­op­ing next-gen­er­a­tion of mul­ti­func­tion­al im­munomod­u­la­to­ry an­ti­bod­ies for can­cer, where he al­so served as a board ob­serv­er.

Kally­ope — fo­cused on iden­ti­fy­ing and pur­su­ing ther­a­peu­tic op­por­tu­ni­ties in­volv­ing the gut-brain ax­is — has wel­comed Juha Lau­ren aboard as CBO. Lau­ren joins the com­pa­ny af­ter a stint as se­nior di­rec­tor, busi­ness de­vel­op­ment and R&D strat­e­gy at Re­gen­eron, fo­cus­ing on deals with Al­ny­lam, blue­bird bio and In­tel­lia Ther­a­peu­tics. Lau­ren be­gan as a neu­ro­sci­en­tist, pub­lish­ing stud­ies in jour­nals in­clud­ing Na­ture and Neu­ron be­fore launch­ing his busi­ness ca­reer as a man­age­ment con­sul­tant with Ac­cen­ture.  

Tracey Franklin has been cho­sen as the chief hu­man re­sources of­fi­cer at Mod­er­na — a com­pa­ny de­vel­op­ing mR­NA ther­a­peu­tics and vac­cines. Franklin hops over af­ter a 15-year stint at Mer­ck, serv­ing as vice pres­i­dent, HR chief tal­ent and strat­e­gy of­fi­cer.

Schol­ar Rock — fo­cused on dis­eases in which pro­tein growth fac­tors play a fun­da­men­tal role — has brought George Nomikos in­to their com­pa­ny as vice pres­i­dent, head of med­ical re­search, mus­cle fran­chise. In this new role, Nomikos will be the med­ical lead for the SRK-015 pro­gram in Spinal Mus­cu­lar At­ro­phy (SMA) as well as fu­ture clin­i­cal pro­grams in the mus­cle fran­chise. Pri­or to jump­ing on board, Nomikos served as the se­nior med­ical di­rec­tor, glob­al med­ical lead for the BI­IB054 clin­i­cal pro­gram for Parkin­son’s at Bio­gen. Nomikos’ pre­vi­ous clin­i­cal work con­tributed to the ap­proval of an­ti­de­pres­sant vor­tiox­e­tine and the ac­cep­tance of the drug la­bel up­dates in the US and EU. His oth­er stints in­clude roles at Sage Ther­a­peu­tics, Take­da, Astel­las Phar­ma, Am­gen and Eli Lil­ly

Kevin Duffy has hopped from Mer­ck and on­board to North­west Bio­ther­a­peu­tics — de­vel­op­ing DC­Vax im­mune ther­a­pies for sol­id tu­mor can­cers, such as Glioblas­toma mul­ti­forme (GBM) — as vice pres­i­dent, med­ical af­fairs and ex­ter­nal col­lab­o­ra­tions. At Mer­ck, Duffy served as re­search sci­en­tif­ic di­rec­tor for the past five years in the Keytru­da pro­gram. Pri­or to his work at Mer­ck, Duffy served in var­i­ous roles, in­clud­ing as re­gion­al sci­en­tif­ic man­ag­er for on­col­o­gy and car­dio­vas­cu­lar ther­a­peu­tics at As­traZeneca.

→ While its lead prod­uct can­di­date, losmapi­mod, is cur­rent­ly in a Phase IIb tri­al to in­ves­ti­gate its po­ten­tial use in fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy (FSHD), Ful­crum Ther­a­peu­tics has ush­ered in Pamela Strode as their se­nior vice pres­i­dent, reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance. Strode jumps to the com­pa­ny af­ter a stint in the same role at Epizyme, where she di­rect­ed mul­ti­ple US fast track and US/EU or­phan drug des­ig­na­tions. Strode for­mer­ly served at Bris­tol-My­ers Squibb, Boehringer In­gel­heim and Cerulean Phar­ma.

→ While col­lab­o­rat­ing with Jazz Phar­ma­ceu­ti­cals in de­vel­op­ing PF743, a re­com­bi­nant crisan­tas­pase, and PF745, a re­com­bi­nant crisan­tas­pase with half-life ex­ten­sion tech­nol­o­gy, Pfenex has an­nounced the ap­point­ment of Steve Kay to its sci­en­tif­ic ad­vi­so­ry board. Kay cur­rent­ly serves as the Di­rec­tor of the Uni­ver­si­ty of South­ern Cal­i­for­nia (USC) MESH Acad­e­my, the Di­rec­tor of the USC Michel­son Cen­ter for Con­ver­gent Bio­science, and is a Provost Pro­fes­sor of Neu­rol­o­gy, Bio­med­ical En­gi­neer­ing and Bi­o­log­i­cal Sci­ences at the Keck School of Med­i­cine of USC.

Eva-Lot­ta Al­lan Ale­ta

Ale­ta Bio­ther­a­peu­tics has made some new ad­di­tions to its board of di­rec­tors, with the ap­point­ments of Mark Leucht­en­berg­er as ex­ec­u­tive chair­man and Eva-Lot­ta Al­lan as non-ex­ec­u­tive di­rec­tor. Leucht­en­berg­er present­ly serves as the in­ter­im CEO at Brook­lyn Im­munoTher­a­peu­tics and Al­lan is the cur­rent non-ex­ec­u­tive di­rec­tor for Tar­go­v­ax and Crescen­do Bi­o­log­ics, as well as chair­man of C4X Dis­cov­ery.

Lyra Ther­a­peu­tics — a biotech fo­cused on de­vel­op­ing med­i­cines to tar­get ear, nose and throat (ENT) dis­eases — has wel­comed Gen­zyme vet, Ann Mer­ri­field, to its board of di­rec­tors. Pre­vi­ous­ly, Mer­ri­field served as the CEO of Patho­Genetix.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

Credit: Shutterstock

Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

The FTC and New York state ac­cuse Mar­tin Shkre­li of run­ning a drug mo­nop­oly. They plan to squash it — and per­ma­nent­ly ex­ile him

Pharma bro Martin Shkreli was jailed, publicly pilloried and forced to confront some lawmakers in Washington riled by his move to take an old generic and move the price from $17.50 per pill to $750. But through 4 years of controversy and public revulsion, his company never backed away from the price — left uncontrolled by a laissez faire federal policy on a drug’s cost.

Now the FTC and the state of New York plan to pry his fingers off the drug once and for all and open it up to some cheap competition. And their lawsuit is asking that Shkreli — with several years left on his prison sentence — be banned permanently from the pharma industry.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,700+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

Endpoints Premium

Premium subscription required

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

Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.