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1. Roche offers an upbeat two-plus-year look at its anti-TIGIT combo therapy — but will two deaths hurt its chances?
2. UPDATED: Moderna says its mRNA flu vaccine cleared early studies, but comparisons with other vaccines drive stock down
3. After investing in their Series B, Lilly bags a license for a batch of metabolic candidates
4. CVS takes a swing at Bristol Myers and Pfizer, excluding coverage of their megablockbuster Eliquis in 2022
5. Oversight Committee unleashes scathing drug pricing report as Senate preps to vote on allowing Medicare negotiations
6. As Biohaven CEO Coric preps FDA filing for new migraine spray, he's already scouting for celebrity spokesperson
7.
bioregnum
Billionaire BioNTech backers have been kicking the tires at Novartis' big generics arm — report
8. The latest healthcare SPAC comes in at $200M with a laser focus on artificial intelligence
9. Dekkers-founded investment firm Novalis LifeSciences raises $300M for second fund and adds to the team
10. Snakebit Angion reports another miss for lead program, as biotech prepares to shift its 'primary focus'
11.
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Flagship on center stage: Axcella’s new CMO likens the biotech to ‘professional sports team’; Life after the FDA takes shape for Stephen Hahn as a chief executive
12. Viatris and Biocon mull pooling their biosimilars into a $10B standalone company — report
13. Covid-19 roundup: UK preps for a wave of Omicron cases; Bourla suggests a fourth dose might be necessary
14. GlaxoSmithKline enlisted Harris Poll for a severe asthma survey — results point to more outreach
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bioregnum
John Carroll
.

Hard to believe that we're looking at the last full work week of the year coming up on Monday. What a year. There's a special ASH report and panel review Monday. We'll be wrapping the last daily report of 2021 on December 23 with a special look at top trends for 2022, as picked by the team. And then we'll be working a part-time schedule to stay up with the news, but only online, through the holidays.

.
John Carroll
Editor & Founder, Endpoints News
@JohnCendpts
1
by Nicole DeFeudis

Roche’s Genen­tech got a leg up in the packed an­ti-TIG­IT race ear­li­er this year when the FDA grant­ed it the first break­through des­ig­na­tion in the field based on some up­beat mid-stage da­ta in non-small cell lung can­cer. Now, look­ing to keep its lead, the phar­ma gi­ant is of­fer­ing a two-and-a-half-year look at the same pa­tient group — but will two deaths crush its chances?

A com­bi­na­tion of Genen­tech’s an­ti-TIG­IT can­cer tiragolum­ab plus PD-L1 in­hibitor Tecen­triq re­duced pa­tients’ risk of dis­ease pro­gres­sion or death by 38% com­pared to those who re­ceived Tecen­triq alone at a me­di­an fol­low-up of 2.5 years, the com­pa­ny said on Fri­day. In a pre-spec­i­fied ex­plorato­ry analy­sis of par­tic­i­pants with high lev­els of PD-L1, the com­bo re­duced the risk of dis­ease wors­en­ing or death by 71% com­pared to the Tecen­triq group.

The com­bo al­so showed a “clin­i­cal­ly mean­ing­ful” im­prove­ment in over­all re­sponse, with a rate of 69% in the com­bo group and 24.1% in the Tecen­triq group for PD-L1-high pa­tients. On the sec­ond end­point, over­all sur­vival, pa­tients in the broad­er pop­u­la­tion sur­vived a me­di­an of 23.2 months on the com­bo, com­pared to 14.5 months on just Tecen­triq, ac­cord­ing to Genen­tech. Me­di­an OS hasn’t yet been reached in the PD-L1-high sub­group that re­ceived the com­bo.

How­ev­er, the com­pa­ny al­so re­port­ed two treat­ment-re­lat­ed deaths in the com­bi­na­tion group. While no ex­pla­na­tion was sup­plied, Mizuho’s Mara Gold­stein thinks tiragolum­ab still stands a chance.

“While Gr.5 events are not to be tak­en light­ly, in the con­text of the ef­fi­ca­cy ob­served, it may not be a weighty is­sue,” she wrote in a note to in­vestors on Fri­day.

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Stéphane Bancel, Moderna CEO (AP Images, Boston Herald)
2
by Jason Mast

Mod­er­na says that it's on its way to hav­ing an mR­NA vac­cine against not one, but two dif­fer­ent sea­son­al virus­es.

The biotech re­leased the first ear­ly da­ta from its flu pro­gram Fri­day morn­ing, an­nounc­ing that all dos­es of the shot sig­nif­i­cant­ly boost­ed an­ti­bod­ies in younger and old­er adults with­out "sig­nif­i­cant safe­ty find­ings."

A 500-per­son Phase II will con­firm dose lev­els and com­pare it to an ap­proved flu vac­cine, the com­pa­ny said, and prepa­ra­tions for a large piv­otal tri­al are un­der­way. Mod­er­na said it is al­so ad­vanc­ing new de­signs that can have po­ten­tial­ly broad­er cov­er­age of dif­fer­ent flu strains than cur­rent shots.

The re­sults are the open­ing sal­vo in a four-head­ed (so far) race to de­vel­op the first mR­NA flu vac­cine, as Mod­er­na tries to edge out BioN­Tech, Sanofi sub­sidiary Trans­late Bio, and Cure­Vac past the gate. Al­though all four have pro­grams un­der­way, Mod­er­na is the first to an­nounce da­ta.

Those da­ta, though, don't give a clear an­swer on whether mR­NA can im­prove on pre­vi­ous tech­nolo­gies. Mod­er­na said the 50 mi­cro­gram dose of the shot, de­signed like most flu vac­cines to in­oc­u­late against four dif­fer­ent strains of the virus, in­creased an­ti­bod­ies against the two In­fluen­za A strains by eight-fold and ten-fold, re­spec­tive­ly, and against the two in­fluen­za strains by three-fold and two-fold.

There was lit­tle dif­fer­ence in an­ti­bod­ies be­tween dose lev­els, the com­pa­ny said. Safe­ty da­ta echoed those from the Covid-19 vac­cine, with fa­tigue, myal­gia (mus­cle ache), and headache the most com­mon side ef­fects.

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Xiayang Qiu, Regor Therapeutics CEO
3
by Josh Sullivan

Eli Lil­ly will li­cense in Re­gor Ther­a­peu­tics ther­a­pies for meta­bol­ic dis­or­ders, as a part of an agree­ment an­nounced Fri­day that will give the Chi­nese biotech an up­front pay­ment of up to $50 mil­lion, part of which is an eq­ui­ty in­vest­ment.

In a vague­ly word­ed re­lease, Lil­ly said it has a li­cense for cer­tain Re­gor "in­tel­lec­tu­al prop­er­ty" and will have an op­tion to ex­tend that li­cense. In ex­change, Lil­ly will over­see glob­al clin­i­cal de­vel­op­ment and com­mer­cial­iza­tion for any ther­a­pies, with the ex­cep­tion of Chi­na, Macau, Hong Kong and Tai­wan. Re­gor, a Shang­hai-based com­pa­ny, will re­serve the rights to these re­gions.

The com­pa­ny is el­i­gi­ble for up to $1.5 bil­lion in po­ten­tial pay­ments based on pre­clin­i­cal, clin­i­cal and com­mer­cial mile­stones, as well as tiered roy­al­ties from sales.

Re­gor CEO Xi­ayang Qiu said that the col­lab­o­ra­tion is, in part, a recog­ni­tion of Re­gor’s core tech­nol­o­gy, the Com­put­er Ac­cel­er­at­ed Ra­tio­nal Dis­cov­ery plat­form. CARD, an­oth­er in a long line of fan­ci­ly named biotech com­pu­ta­tion­al plat­forms, is de­signed to cre­ate a more ef­fi­cient process for the dis­cov­ery of new drugs.

Through CARD, the team has ad­vanced a num­ber of prod­ucts in its pipeline in just two years, in­clud­ing RGT-587 for on­col­o­gy, which is set to en­ter Phase I tri­als, and and RGT-075 to tar­get a glucagon-like pep­tide 1 re­cep­tor hor­mone, which stim­u­lates glu­cose-in­duced in­sulin se­cre­tion. That can­di­date is en­ter­ing Phase II/III tri­als.

The com­pa­ny was found­ed in 2018 by a team that in­cludes two Pfiz­er vet­er­ans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Am­gen’s Chi­nese R&D op­er­a­tions. Re­gor’s fo­cus so far has been on on­col­o­gy, meta­bol­ic dis­eases and au­toim­mune dis­eases.

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Optimizing for subtype ratio | CAR-T therapy effectiveness
In this webinar, learn about Poseida Therapeutics’ approach to transitioning from autologous to fully allogeneic CAR-T therapy manufacturing.
sponsored by Sartorius
4
by Zachary Brennan

Bris­tol My­ers Squibb brought in more than $9 bil­lion in sales from its an­ti­co­ag­u­lant Eliquis in 2020, and it con­tin­ues to see growth with more than $8 bil­lion in sales in the first nine months of 2021 (and an­oth­er near­ly $4.5 bil­lion for Pfiz­er in 2021).

But in 2022, one of the largest PBMs in the US, CVS Care­mark, has re­cent­ly de­cid­ed to no longer cov­er the megablock­buster, and in­stead will on­ly of­fer cov­er­age for war­farin and Janssen's Xarel­to.

That de­ci­sion will like­ly put a dent in Eliquis sales next year for both BMS and Pfiz­er.

But BMS said the de­ci­sion should be lim­it­ed, telling End­points News in an emailed state­ment that while the Bris­tol My­ers Squibb-Pfiz­er al­liance "is dis­ap­point­ed" by this move to hin­der pa­tient ac­cess to Eliquis, the drug will con­tin­ue to have "pre­ferred sta­tus for 85% of CVS Health lives in 2022 and on­ly those pa­tients who have com­mer­cial health in­sur­ance plans with phar­ma­cy ben­e­fits man­aged by Zinc, specif­i­cal­ly, are sub­ject to their for­mu­la­ries and this de­ci­sion, ef­fec­tive Jan­u­ary 1, 2022. Im­por­tant­ly, 95% of Eliquis pa­tients na­tion­al­ly will not be ef­fect­ed by this for­mu­la­ry de­ci­sion by CVS/Zinc." (Bold and ital­ics are theirs.)

For some doc­tors, the de­ci­sion forces them to scram­ble and switch pa­tients to a new an­ti­co­ag­u­lant, and they don't have time to fig­ure out if their pa­tients fall in­to the gap dis­cussed by BMS and Pfiz­er.

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House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images)
5
by Zachary Brennan

Back in Jan­u­ary 2019, the late House Over­sight Com­mit­tee chair Eli­jah Cum­mings kicked off a near­ly 3-year-long drug pric­ing in­ves­ti­ga­tion that cul­mi­nat­ed to­day in a ma­jor new re­port de­tail­ing how prices for vi­tal drugs have risen sub­stan­tial­ly since their launch, while call­ing on the Sen­ate to pass a bill that will al­low Medicare to ne­go­ti­ate some prices.

The com­mit­tee's in­ves­ti­ga­tion fo­cused on 12 of the most ex­pen­sive drugs for Medicare, show­ing mas­sive price spikes that have ac­cu­mu­lat­ed over the years and made some drugs, like in­sulin, en­tire­ly un­af­ford­able for some, to the point where some di­a­bet­ics have had to ra­tion their life-sav­ing in­sulin, and some have died.

Doc­u­ments ob­tained by the com­mit­tee show that sev­er­al of the com­pa­nies tar­get­ed Medicare specif­i­cal­ly to boost rev­enues.

An in­ter­nal No­vo Nordisk slide deck from Oc­to­ber 2013 em­pha­sized, “Part D is the most prof­itable mar­ket for the No­vo Nordisk in­sulin port­fo­lio,” and not­ed that in­sulin vol­ume for the Part D mar­ket was grow­ing three times faster than the com­mer­cial mar­ket. A 2016 pre­sen­ta­tion pre­pared for No­var­tis by an out­side con­sul­tant em­pha­sized, “Medicare is crit­i­cal to brand suc­cess, CMS spent ~$1 bil­lion on Gleevec in 2014.”

Build­ing off the work of three hear­ings with phar­ma­ceu­ti­cal ex­ec­u­tives from sev­en com­pa­nies, as well as oth­er pre­vi­ous re­ports, this fi­nal re­port in­cludes new find­ings from an in­ves­ti­ga­tion in­to Pfiz­er’s mar­ket­ing of its block­buster pain drug Lyri­ca, and a deep­er dive in­to the in­sulin prod­ucts from Eli Lil­ly, No­vo Nordisk, and Sanofi, which col­lec­tive­ly con­trol about 90% of the glob­al in­sulin mar­ket.

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Vlad Coric, Biohaven chariman and CEO
6
by Beth Snyder Bulik

Days af­ter re­port­ing pos­i­tive Phase III re­sults for in­tranasal mi­graine med za­veg­epant, Bio­haven chair­man and CEO Vlad Coric is talk­ing about mar­ket­ing plans. It’s a month or more be­fore Bio­haven will file for FDA ap­proval and like­ly a year be­fore launch, but Coric is al­ready think­ing about mes­sag­ing and com­mer­cial­iza­tion.

His plan? A dual strat­e­gy to at­tract po­ten­tial pa­tients around speed to re­lief – za­veg­epant study re­sults show the spray can pro­vide re­lief in as fast as 15 min­utes and a re­turn to nor­mal in 30 min­utes – along with a sec­ondary an­ti-nau­sea ben­e­fit in us­ing an in­tranasal ver­sus a pill.

“It’s go­ing to be com­ple­men­tary to Nurtec and many peo­ple are go­ing to want this around be­cause you don’t con­trol when a mi­graine hits,” Coric said. “Now you can con­trol which of these tools you can take to­day to com­bat your mi­graine.”

He’s al­ready scout­ing for a new celebri­ty spokesper­son to add an­oth­er well-known voice to its group of ad­ver­tis­ing am­bas­sadors for Nurtec ODT that in­cludes re­al­i­ty TV star Khloe Kar­dashi­an and ac­tor and talk show host Whoopi Gold­berg.

That’s all of course con­di­tion­al on FDA ap­proval. The pos­i­tive Phase III da­ta Bio­haven de­tailed ear­li­er this week showed za­veg­epant was su­pe­ri­or to place­bo on the co-pri­ma­ry end­points of pain free­dom and free­dom from most both­er­some symp­toms at two hours, and su­pe­ri­or to place­bo in de­liv­er­ing pain re­lief as ear­ly as 15 min­utes.

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Bioregnum: Opinions and views from John Carroll
7

While the ul­ti­mate fate of No­var­tis’ big gener­ics arm San­doz may still be up in the air, there’s no doubt it’s in play as a po­ten­tial buy­out tar­get.

Overnight, Reuters picked up on a re­port out of Ger­many that EQT and the bil­lion­aire Strüng­mann broth­ers — en­joy­ing a huge wind­fall from the overnight suc­cess of BioN­Tech’s mR­NA Covid vac­cine — are kick­ing the tires at San­doz. And No­var­tis CEO Vas Narasimhan con­firmed it.

"There have been var­i­ous re­quests for more in­for­ma­tion,” Narasimhan told WirtschaftsWoche. “But no con­crete of­fers.”

This is the sec­ond re­port out of Ger­many on the dis­cus­sions over San­doz. Han­dels­blatt re­port­ed more than a week ago that EQT and the Strüng­manns — Thomas and An­dreas — were in talks over a $21 bil­lion bid. And it would­n't be their first gener­ics deal, as the bil­lion­aires sold Hexal to No­var­tis in 2005.

Narasimhan's de­ci­sion to con­firm their in­ter­est — rather than just re­main mum — leaves lit­tle doubt in just how much he would like an auc­tion to get go­ing. He just lined up a $21 bil­lion fund for new deals with his sale of the Roche stake. A San­doz sale would make him a for­mi­da­ble po­ten­tial buy­er in 2022.

Narasimhan got every­one’s at­ten­tion at the end of Oc­to­ber when he flagged a plan to un­der­take a strate­gic re­view of San­doz to see whether the gener­ics group should stay in­side No­var­tis, or be sold or spun off in­to an in­de­pen­dent com­pa­ny.

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Catalent
8
by Max Gelman

A new health­care SPAC is ex­pect­ed to price dur­ing Fri­day’s ses­sion, and it’s one that wants to take ad­van­tage of the in­dus­try’s buzzi­est sec­tor.

The blank check com­pa­ny will make a $200 mil­lion de­but on Nas­daq, com­ing to the pub­lic mar­ket on the backs of Stan­ley Cap­i­tal fundrais­ing. This SPAC is not on­ly tar­get­ing life sci­ences, but life sci­ences com­pa­nies with a spe­cif­ic fo­cus on ar­ti­fi­cial in­tel­li­gence. One need not look past the name as ev­i­dence — Health­care AI Ac­qui­si­tion Corp.

Ac­cord­ing to the S-1 fil­ing, the SPAC is aim­ing to tar­get com­pa­nies “with high AI readi­ness and tech­no­log­i­cal trans­for­ma­tion po­ten­tial.” The pri­ma­ry fo­cus will be in the US and Eu­rope in op­er­a­tions “where the ad­di­tion­al in­te­gra­tion of an AI or au­toma­tion so­lu­tion can cre­ate in­cre­men­tal trans­for­ma­tion­al val­ue.”

Led by Stan­ley Cap­i­tal’s found­ing part­ners Si­mon Cot­tle and Patrick Hargutt, the SPAC team be­lieves such val­ue can be found in any of three sec­tors in health­care. The first two deal less with drug R&D but re­main tan­gen­tial: with­in the S-1, the team lays out how AI will blos­som in clin­i­cal tri­al soft­ware and health­care IT.

But the com­pa­ny lays out most of its de­tails re­gard­ing the third area — out­sourced phar­ma­ceu­ti­cal ser­vices, such as CROs and CMOs. The S-1 lays out how such out­sourc­ing has trend­ed up in the last sev­er­al years, cit­ing a BCC Re­search es­ti­mate say­ing this ser­vices mar­ket will grow to $266 bil­lion by 2025.

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9
by Paul Schloesser

Two years ago, life sci­ences VC No­valis Life­Sciences an­nounced that it had raised $85 mil­lion for its first fund, look­ing to in­vest in­to any­where be­tween 8 to 12 com­pa­nies "in var­i­ous seg­ments of the life sci­ence in­dus­try." No­valis now wants to go big­ger, an­nounc­ing ear­li­er this week it raked in $300 mil­lion for No­valis Life­Sciences In­vest­ments II.

The New Hamp­shire-based VC, found­ed in 2017 by Gink­go Bioworks board chair­man and ex-Bay­er CEO Mar­i­jn Dekkers, plans to in­vest in­to any­where be­tween 10 and 15 more life sci­ence com­pa­nies.

So far, No­valis has not list­ed from where — or who — it's got­ten its fund­ing, but in to­tal, the firm man­ages ap­prox­i­mate­ly $500 mil­lion in the two in­vest­ment funds.

Over the past few years, No­valis has in­vest­ed and backed quite a few com­pa­nies un­der the biotech um­brel­la, from ther­a­peu­tics to food pro­duc­tion. On the ther­a­peu­tics side, some of those biotechs in­clude:

  • Gink­go, where Dekkers is chair­man of the board, and the biotech was the sub­ject of a short sell at­tack last month — amidst it re­veal­ing it­self as a tar­get of a DOJ probe;
  • De­ci­pher Bio­sciences, an on­col­o­gy di­ag­nos­tics com­pa­ny that em­pha­sizes can­cer ge­nomics and was bought out by Ve­r­a­cyte ear­li­er this year;
  • Cerev­el Ther­a­peu­tics, a Cam­bridge, MA biotech fo­cus­ing on CNS drug can­di­dates that went pub­lic via SPAC in Oc­to­ber 2020.

In ad­di­tion, sev­er­al oth­er peo­ple had re­cent­ly joined No­valis: trust op­er­a­tions vet­er­an Con­stan­tine Pan­telis as COO, and ex-Ther­mo Fish­er sci­en­tist and for­mer head of DNA syn­the­sis at Gink­go, Devin Leake, as man­ag­ing di­rec­tor. Paul Meis­ter, who as then-vice chair­man of Fish­er Sci­en­tif­ic and worked with Dekkers close­ly on the Ther­mo Fish­er merg­er back in 2006, has got­ten on board and joined the VC firm as part­ner.

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sponsored by Catalent, PWC, Takeda, FUJIFILM Diosynth Biotechnologies, Metagenomi, MedRhythms, Akili, Linus Health and Cognito Therapeutics
10
by Max Gelman

An­gion’s lead or­gan dam­age drug took two strikes ear­li­er this year, flop­ping as a re­pur­posed ef­fort for Covid-19 and whiff­ing in high-risk kid­ney trans­plant pa­tients. The biotech re­port­ed a third on Thurs­day, rais­ing se­ri­ous ques­tions about the pro­gram’s fu­ture.

In a Phase II study look­ing at some car­diac surgery pa­tients at risk of kid­ney in­jury, An­gion re­port­ed its ANG-3777 can­di­date missed bad­ly on the pri­ma­ry end­point. The re­sults come about a month and a half af­ter the kid­ney trans­plant study and less than five months af­ter the Covid-19 tri­al, os­ten­si­bly leav­ing the can­di­date on the chop­ping block.

ANGN shares were down about 18% af­ter the bell Thurs­day evening and in­to ear­ly Fri­day morn­ing.

Dur­ing a Thurs­day af­ter­noon in­vestor call, CEO Jay Venkate­san im­plied this could be end of the road for ANG-3777, say­ing An­gion’s “pri­ma­ry fo­cus” mov­ing for­ward will be its Phase II ty­ro­sine ki­nase re­cep­tor in­hibitor, ANG-3070. But An­gion and its part­ner Vi­for Phar­ma will need to fur­ther re­view the da­ta, he said, not­ing a de­ci­sion will like­ly be made some­time in ear­ly 2022 about next steps.

Much of An­gion’s fo­cus post-re­veal dealt with a sec­ondary end­point that al­so missed sta­tis­ti­cal sig­nif­i­cance, but one which the com­pa­ny said is more com­mon­ly used as a reg­u­la­to­ry bench­mark. In dam­age con­trol mode on the in­vestor call, Venkate­san stressed this point and not­ed An­gion still wants to take a clos­er look at the da­ta.

“We have been clear with in­vestors that this tri­al was not in­tend­ed to gen­er­ate sta­tis­ti­cal­ly sig­nif­i­cant re­sults, par­tic­u­lar­ly on the MAKE90 end­point, where we be­lieve we were not suf­fi­cient­ly pow­ered,” Venkate­san said.

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Peer Review: Weekly biopharma job report
11
by Alex Hoffman, Kathy Wong, Paul Schloesser

Mar­garet Koziel has bounced back and forth be­tween acad­e­mia and biotech through­out her ca­reer — and af­ter 25 years, she has land­ed her first po­si­tion as part of a biotech's top brass.

Koziel joined Ax­cel­la Ther­a­peu­tics — found­ed by Flag­ship’s Noubar Afeyan, Ge­of­frey von Maltzahn and David Berry as Ax­cel­la Health — in 2019, and as of Mon­day, she is now in the C-suite as the biotech’s new CMO.

As a self-de­scribed ap­plied sci­en­tist, Koziel’s ca­reer has been star-stud­ded: af­ter grad­u­at­ing from Dart­mouth and its med­ical school, she went to Har­vard Med­ical School, where she taught as an as­so­ciate pro­fes­sor of med­i­cine for 12 years. And af­ter Har­vard, Koziel first crossed over in­to biotech and took a job with No­var­tis as their head of trans­la­tion­al med­i­cine in in­fec­tious dis­ease.

Af­ter jump­ing from No­var­tis to Ver­tex, she re­turned to acad­e­mia — but this time at UMass, wear­ing a va­ri­ety of hats for the five years she was there: every­thing from pro­fes­sor of med­i­cine to di­rec­tor of clin­i­cal re­search and up to as­sis­tant vice provost in clin­i­cal re­search.

And then, she crossed right back in­to the realm of biotech with a job at Kalei­do Bio­sciences, which then led her to Ax­cel­la two and a half years ago, where she climbed the lad­der from glob­al pro­gram team lead to VP of clin­i­cal de­vel­op­ment and ul­ti­mate­ly to CMO.

For Koziel, she joined the com­pa­ny be­cause of its mod­el us­ing “en­doge­nous meta­bol­ic mod­u­la­tors” — mol­e­cules that could po­ten­tial­ly re­store health across a net­work of dis­reg­u­lat­ed path­ways.

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12
by Zachary Brennan

Vi­a­tris (My­lan/Pfiz­er's Up­john) and In­di­a's Bio­con Bi­o­log­ics are re­port­ed­ly pon­der­ing whether to fur­ther en­twine their biosim­i­lar busi­ness­es in­to a $10 bil­lion stand­alone com­pa­ny, ac­cord­ing to sources from Nisha Pod­dar at an In­di­an af­fil­i­ate of CN­BC.

Ear­li­er this sum­mer, the two com­pa­nies won the first high­ly-cov­et­ed in­ter­change­abil­i­ty des­ig­na­tion for their biosim­i­lar Sem­glee, which is an in­sulin that's in­ter­change­able with Sanofi's Lan­tus. Al­though, in a bizarre twist with the way the US in­sulin mar­ket works, the com­pa­nies had to launch two ver­sions of the in­ter­change­able — one at a 65% dis­count, and one at a much high­er price in or­der to gain mar­ket share.

https://twit­ter.com/CN­BCTV18News/sta­tus/1468792319625203713

A Vi­a­tris spokesper­son told End­points News via email, "We don’t com­ment on mar­ket ru­mors and spec­u­la­tion."

Such a deal would bring clos­er to­geth­er two com­pa­nies that are al­ready de­vel­op­ing, man­u­fac­tur­ing and com­mer­cial­iz­ing a port­fo­lio of biosim­i­lars and in­sulin analogs, in­clud­ing biosim­i­lars to Hu­mi­ra, Her­ceptin, Neu­las­ta, and En­brel.

Vi­a­tris, which saw its com­plex gener­ics and biosim­i­lars busi­ness bring in about $1 bil­lion in net sales in the first nine months of 2021, has ex­clu­sive com­mer­cial­iza­tion rights for the biosim­i­lars in the US, Cana­da, Aus­tralia, New Zealand, the EU and Eu­ro­pean Free Trade As­so­ci­a­tion coun­tries. Bio­con Bi­o­log­ics has ex­clu­sive com­mer­cial­iza­tion rights for Japan and cer­tain emerg­ing mar­kets. And they have co-ex­clu­sive com­mer­cial­iza­tion rights in the rest of the world.

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13
by Zachary Brennan

With re­ports of Omi­cron cas­es in over 50 coun­tries, and at least 19 US states, some re­gions like the UK are now ex­pect­ing a rapid rise of Omi­cron as com­mu­ni­ty spread takes off.

While the UK has on­ly seen about 800 Omi­cron cas­es so far, the gov­ern­ment’s Health Se­cu­ri­ty Agency warned that if the re­cent growth rate con­tin­ues, “we ex­pect to see at least 50 per­cent of Covid-19 cas­es to be caused by the Omi­cron vari­ant in the next two to four weeks,” ac­cord­ing to the New York Times.

John Ed­munds, an epi­demi­ol­o­gist at the Lon­don School of Hy­giene & Trop­i­cal Med­i­cine, said that plan B mea­sures an­nounced by PM Boris John­son were “ab­solute­ly not an over­re­ac­tion” even if Omi­cron turned out to be milder than the cur­rent dom­i­nant vari­ant, ac­cord­ing to The Guardian.

Ed­munds told a Roy­al So­ci­ety of Med­i­cine we­bi­nar Thurs­day that it was “ex­treme­ly like­ly” there's more Omi­cron in com­mu­ni­ties, adding, "With the speed of spread of this virus, we may well have re­al­ly sig­nif­i­cant num­bers of cas­es by Christ­mas."

Mean­while, CDC di­rec­tor Rochelle Walen­sky said Wednes­day that her staff is "avail­able 24/7, as they have been through­out this en­tire pan­dem­ic, to pro­vide in-per­son and re­mote tech­ni­cal sup­port for the pub­lic health re­sponse to the Omi­cron vari­ant, in­clud­ing in­ves­ti­ga­tions of the epi­demi­o­log­ic and clin­i­cal char­ac­ter­is­tics of Omi­cron or oth­er SARS-CoV-2 in­fec­tions."

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14
by Beth Snyder Bulik

Peo­ple with cer­tain chron­ic con­di­tions are far­ing worse than oth­ers dur­ing the pan­dem­ic. A new sur­vey from The Har­ris Poll com­mis­sioned by Glax­o­SmithK­line finds that peo­ple with asth­ma, specif­i­cal­ly se­vere eosinophilic asth­ma, are among them.

More than two-thirds (68%) of pa­tients di­ag­nosed with se­vere eosinophilic asth­ma sur­veyed de­scribe their health as fair or poor – and that may be down­play­ing the re­al­i­ty. Nine­ty per­cent of physi­cians who see se­vere asth­ma pa­tients sur­veyed rate their pa­tients’ over­all qual­i­ty of life us­ing the same fair or poor de­scrip­tors.

"We know that pa­tients will of­ten ac­cept where they are and just feel this is how it is with se­vere asth­ma," Tom Cor­bridge, se­nior med­ical lead at GSK in the US, said. "When they come in­to the of­fice and are asked how they're do­ing, they may say 'OK.' But that type of un­der­re­port­ing may set the doc­tor up for po­ten­tial­ly un­der-rec­og­niz­ing where they tru­ly are."

Mean­while, the on­go­ing Covid-19 pan­dem­ic has been both bless­ing and curse for asth­mat­ics. Few­er pa­tients are hav­ing flare-ups thanks to less ex­po­sure to trig­gers like res­pi­ra­to­ry in­fec­tions and poor air qual­i­ty aid­ed by mask­ing and stay­ing home more of­ten. How­ev­er, it’s al­so like­ly that few­er pa­tients have been di­ag­nosed be­cause of skipped or de­layed doc­tors' vis­its and less test­ing, Cor­bridge said.

The Har­ris Poll re­sults show that while GSK has made some progress in se­vere asth­ma, it needs to dou­ble down on ed­u­ca­tion and aware­ness ef­forts with both pa­tient ad­vo­ca­cy groups and physi­cians, he said.

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