Ab­bott Lab­o­ra­to­ries CEO Miles White pass­es ba­ton down to suc­ces­sor; Lon­za CEO Marc Funk hits the ex­it

Robert Ford Ab­bott

Ab­bott Lab­o­ra­to­ries has named a suc­ces­sor to CEO Miles White af­ter he an­nounced that he was step­ping down in March af­ter 21 years of ser­vice. Robert Ford, the com­pa­ny’s COO and pres­i­dent, will take the helm. Ford is known for his work in the $25 bil­lion merg­er be­tween St. Jude Med­ical in­to Ab­bott in Jan­u­ary 2017. White will re­main with the com­pa­ny as ex­ec­u­tive chair­man of the board. 

→ Af­ter snap­ping up No­var­tis’ Swiss fa­cil­i­ty, No­var­tis Cen­ter of Ex­cel­lence, in Ju­ly, Lon­za has an­nounced that their CEO, Marc Funk, is hit­ting the ex­it for “per­son­al rea­sons.” Funk has been the CEO of the com­pa­ny for less than a year — brought on­to the com­pa­ny back in March. In the mean­time, chair­man Al­bert Baehny will serve as in­ter­im CEO. 

Marc Funk Lon­za

Rakuten Med­ical — which, back in Au­gust, re­ceived $100 mil­lion in a fund­ing round — has wel­comed Bren­ton Keath as CFO and Dana John­son as gen­er­al coun­sel and cor­po­rate sec­re­tary. Keath pre­vi­ous­ly served as head of fi­nance for Rakuten Com­merce and held the role of VP of merg­ers & ac­qui­si­tions in­te­gra­tion at Rakuten USA. Most re­cent­ly, John­son com­plet­ed a stint at Grit­stone On­col­o­gy. In ad­di­tion, the com­pa­ny ap­point­ed co-founder and gen­er­al part­ner of DCM Ven­tures, David Chao, and COO and group EVP of Rakuten, Ken­taro Hyakuno, as di­rec­tors to the com­pa­ny’s board. 

→ In­vest­ment group Abing­worth has tapped Neil Coop­er as CFO. Coop­er is suc­ceed­ing James Abell, who is re­tir­ing af­ter 21 years of ser­vice. Coop­er joins the com­pa­ny af­ter a stint as fi­nance di­rec­tor at Ken­net Part­ners. He has pre­vi­ous­ly served in roles at Robert W Baird, Baird Cap­i­tal Part­ners Eu­rope and Ad­vent Ven­ture Part­ners

→ Ox­ford, UK-based re­search com­pa­ny Arc­toris — which closed a seed fund­ing round of £3.2 mil­lion back in Sep­tem­ber — has wel­comed GSK vet Daniel Thomas as head of dis­cov­ery bi­ol­o­gy. In ad­di­tion, Arc­toris ap­point­ed for­mer CEO of Ge­nomics Eng­land John Mattick to the com­pa­ny’s board of di­rec­tors.

Verseau Ther­a­peu­tics — which re­cent­ly armed with Langer tech and $50 mil­lion to help bring their first macrophage check­point mod­u­la­tor (MCM) for the treat­ment of can­cer to the clin­ic — has wel­comed Tim Smith as CBO. Smith has served in roles at Do­va Phar­ma­ceu­ti­cals, IDEAYA Bio­sciences, Cleave Bio­sciences and as ex­ec­u­tive di­rec­tor, busi­ness de­vel­op­ment Cel­gene — where he helped lead the ac­qui­si­tion of Re­cep­tos and col­lab­o­ra­tion with Jounce Ther­a­peu­tics.

Ar­row­head Phar­ma­ceu­ti­cals has an­nounced that the com­pa­ny’s COO and head of R&D, Bruce Giv­en, is re­tir­ing from the com­pa­ny. Giv­en joined the com­pa­ny in 2011 and pri­or to that was the CEO of Leonar­do Biosys­tems. His pre­vi­ous stints in­clude CEO of En­cy­sive Phar­ma­ceu­ti­cals and roles at J&J, San­doz Phar­ma and Scher­ing-Plough.  

Ru­bius Ther­a­peu­tics — a clin­i­cal-stage bio­phar­ma­ceu­ti­cal com­pa­ny de­vel­op­ing a new class of red blood cell ther­a­peu­tics — has named Maiken Ke­son-Brookes as chief le­gal of­fi­cer and cor­po­rate sec­re­tary. Ke­son-Brookes most re­cent­ly served as gen­er­al coun­sel at Syn­log­ic and pri­or to that was the SVP and gen­er­al coun­sel at uniQure. Her pre­vi­ous stints in­clude roles at Fo­rum Phar­ma­ceu­ti­cals, Gen­zyme and Bio­gen

RubrYc Ther­a­peu­tics — fo­cused on can­cer and au­toim­mune dis­eases — has hired Rakesh Ver­ma as SVP, dis­cov­ery & de­vel­op­ment. Be­fore join­ing the com­pa­ny, Ver­ma was the site-head of AR­MO Bio­sciences and as­so­ciate VP at Eli Lil­ly

Aruna Bio — fo­cused on the de­vel­op­ment of neur­al ex­o­somes for the treat­ment of neu­rode­gen­er­a­tive dis­eases — has brought on Re­nee Boern­er as VP of reg­u­la­to­ry af­fairs. Boern­er joins the com­pa­ny from Bavar­i­an Nordic, where she served as head of US reg­u­la­to­ry af­fairs. Pri­or to that, she was the head of reg­u­la­to­ry af­fairs at BioDe­liv­ery Sci­ences

Lim­i­nal Bio­Sciences — de­vel­op­ing treat­ments for pa­tients with liv­er, res­pi­ra­to­ry and kid­ney dis­ease — has hired Moira Daniels as head of reg­u­la­to­ry af­fairs and qual­i­ty as­sur­ance. Daniels joins the com­pa­ny from UCB Phar­ma as their VP, head of glob­al reg­u­la­to­ry op­er­a­tions. Daniels’ pre­vi­ous stints in­clude roles at As­traZeneca, Pfiz­er and Eli Lil­ly

Nor­man Bay­lor Bi­o­log­ics Con­sult­ing

→ Eq­ui­ty firm CBC Group has ap­point­ed Ker­ry Blan­chard as op­er­at­ing part­ner. Most re­cent­ly, Blan­chard served as CSO at In­novent Bi­o­log­ics, where he over­saw the NDA prepa­ra­tion and sub­mis­sion of the com­pa­ny’s PD1 an­ti­body, sin­til­imab (ap­proved in late 2018 and launched in Chi­na in 2019). Pre­vi­ous­ly, Blan­chard held a stint as SVP of Lil­ly Chi­na Drug De­vel­op­ment and Ex­ter­nal In­no­va­tion.

→ French vac­cine de­vel­op­er Val­ne­va — which closed out a part­ner­ship with Glax­o­SmithK­line in June — has added two vac­cine ex­perts, Nor­man Bay­lor and George Siber, to its sci­en­tif­ic ad­vi­so­ry board. Bay­lor is cur­rent­ly the CEO of Bi­o­log­ics Con­sult­ing Group and is a for­mer di­rec­tor of the of­fice of vac­cines re­search and re­view at the FDA Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search — fa­cil­i­tat­ing the de­vel­op­ment and li­cen­sure of vac­cines such as HPV and in­fluen­za. Siber is the for­mer di­rec­tor at the Mass­a­chu­setts Bi­o­log­ic Lab and EVP and CSO at Wyeth Vac­cines.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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