The 10 most pop­u­lar re­ports in End­points News — so far

A lit­tle more than 5 months ago, Ar­salan Arif and I launched the main edi­tion of End­points News. We hit the ground run­ning and gun­ning for a dai­ly in­dus­try re­port that would pro­vide some re­al in­sights on the deals, da­ta and dra­ma flow­ing around the bio­phar­ma world every day.

We’re all about the lat­est news in con­text, guid­ed by 13+ years of dai­ly cov­er­age. And we re­cent­ly passed is­sue #100, with about a quar­ter mil­lion words of search­able con­tent.

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We’re us­ing the Thanks­giv­ing break to high­light what you, our read­ers, have vot­ed as the most pop­u­lar con­tent we’ve put up in that time. The top 10 links, ranked by web traf­fic, starts with a scoop and ends with two sto­ries about back-to-back dis­as­ters that oc­curred ear­li­er this week and im­me­di­ate­ly went se­mi-vi­ral.

So with­out more ado, here’s the most clicked sto­ries of 2016, so far.

1. Scoop: No­var­tis dis­bands its pi­o­neer­ing cell and gene ther­a­py unit

We got a tip ear­ly on Au­gust 31 that No­var­tis was dis­solv­ing its 400-per­son cell and stem cell unit and lay­ing off a bunch of the staffers. When I first heard it, I thought it had to be wrong. Why now? Just as the first cell ther­a­pies in CAR-T were head­ing for reg­u­la­tors? And with com­pe­ti­tion breath­ing down its neck? It didn’t make any sense. The com­pa­ny, though, con­firmed the sto­ry, and our news break trig­gered a seis­mic re­ac­tion in the in­dus­try, which al­so wasn’t ex­pect­ing it. The moral of this sto­ry is that we are all ears. If you send us a good tip, we’ll check it out. (You can se­cure­ly send us things us­ing PGP.)

This is one of sev­er­al big changes we’ve tracked at No­var­tis in re­cent months. Al­so among our top sto­ries: No­var­tis un­veils a new glob­al R&D struc­ture, cre­at­ing cen­ters in Cam­bridge, MA and Basel. And there was this: No­var­tis’ re­treat on CAR-T in­cludes ax­ing most of its se­nior ex­ecs on the team.

 

2. Where the mon­ey is: The top 100(+) VCs in­vest­ing in the US

There are few in­dus­tries where da­ta is more high­ly re­gard­ed than in biotech. So it’s no sur­prise that a de­tailed list of the top VC out­fits op­er­at­ing in the US — ranked by the num­bers — was a hit just as we start­ed the new on­line news source. And it con­tin­ues to at­tract a steady stream of traf­fic from an in­dus­try which is fu­eled by bil­lions in ven­ture cash each year. Cal­i­for­nia, with a big Bay Area clus­ter and a siz­able hub in San Diego, clear­ly at­tract­ed most of the cash. And Boston/Cam­bridge is clear­ly the sec­ond big US hub. Keep an eye on this site: We’ll be back in 2017 with more de­tailed num­bers.

 

3. The 15 top R&D spenders in the glob­al bio­phar­ma busi­ness

More num­bers, this time break­ing our the top 15 re­search spenders in the in­dus­try. This is the life blood of in­no­va­tion, as we know it. And the con­tin­ued in­vest­ment in R&D is at the heart of the grow­ing de­bate over drug pric­ing in Amer­i­ca. The top 15 spenders ac­count for the li­on’s share of re­search spend­ing in bio­phar­ma, and I’ve been fol­low­ing the chang­ing struc­tures and strate­gies be­hind each of these com­pa­nies for more than a decade. Each year we see more R&D group over­hauls, but un­der­ly­ing every­thing has been a big com­mit­ment to seek­ing out and part­ner­ing with ex­ter­nal col­lab­o­ra­tors. That’s been re­ward­ed with mixed re­sults.

 

4. Top 10 pipeline blowups, set­backs and sna­fus in H1 2016

It’s al­ways a bit of a strug­gle to come up with my lat­est set of top pipeline blowups. Not be­cause they’re rare. Quite the op­po­site. Lim­it­ing my­self to 10 can be dif­fi­cult. At the top of this first list for End­points is Clo­vis, which has nev­er ful­ly ex­plained the mys­te­ri­ous switch-up in the da­ta it pre­sent­ed on rocile­tinib. The com­pa­ny stopped re­spond­ing to my queries months ago as it hun­kered down to weath­er a tsuna­mi of law­suits and a fed­er­al in­ves­ti­ga­tion. Mean­while, it’s been fo­cused on its PARP in­hibitor ru­ca­parib, which looks to be squar­ing off against some tough com­pe­ti­tion. Some of the top 10 are the un­for­tu­nate con­se­quence of a sim­ple bi­o­log­ic mis­take. Some are cau­tion­ary tales that of­fer a glimpse of how not to go about drug de­vel­op­ment. Some­times, that can be hard to dis­tin­guish. But it’s al­ways in­ter­est­ing.

 

5. Mer­ck trig­gers a new round of lay­offs in R&D re­or­ga­ni­za­tion, push­ing more jobs in­to Cam­bridge, San Fran­cis­co

One of the biggest sin­gle trends over the past few years has been the mi­gra­tion of bio­phar­ma R&D in­to the big hubs. And Mer­ck demon­strat­ed its com­mit­ment to that hub strat­e­gy back in Ju­ly as it set off a new round of lay­offs while mov­ing more of its re­search op­er­a­tions in­to Boston and the Bay Area, the two gi­ant clus­ters in the US. In just the last few months we’ve seen new over­hauls — both big and small — at No­var­tis, As­traZeneca, Pfiz­er and Glax­o­SmithK­line as well, con­tin­u­ing a years-long process. It may nev­er end. Con­stant change is the rule in R&D, whether you push it or it push­es you.

 

6.  Two more pa­tients die as Juno’s lead CAR-T turns lethal again; tri­al halt­ed

This is not your typ­i­cal pipeline cat­a­stro­phe. Juno al­ready ex­pe­ri­enced an ex­tra­or­di­nar­i­ly short clin­i­cal hold for its lead CAR-T back in the sum­mer, fol­low­ing the deaths of 4 pa­tients in two stud­ies. At the time, they man­aged to con­vince the FDA that they were quite cer­tain that drop­ping one of the drugs used to con­di­tion pa­tients would solve that nasty neu­ro­tox­i­c­i­ty is­sue. The FDA agreed in a mat­ter of days, and now two more pa­tients have been killed. I sus­pect that Juno’s next move will be to drop JCAR015 and in­stant­ly shift fo­cus to JCAR017, their next top pipeline hope­ful. But we need a much, much bet­ter ac­count­ing of what hap­pened here, from the com­pa­ny as well as the FDA. A call with an­a­lysts by the com­pa­ny and a long-wind­ed ‘no com­ment’ from the FDA isn’t go­ing to cut it.

 

7. Don­ald Trump sends a vague­ly word­ed love let­ter to bio­phar­ma as stock ral­ly con­tin­ues

I’ll ad­mit that we don’t have a whole lot of de­tailed in­sight in­to what Don­ald Trump is think­ing about when it comes to bio­phar­ma. Maybe that’s one rea­son why this sto­ry about his en­thu­si­as­tic, though com­plete­ly un­ex­plained, po­si­tion sup­port­ing a re­formed FDA and faster drug ap­provals at­tract­ed so much at­ten­tion. We want to know what he’s think­ing, but for now we’ll have to set­tle for what we can get. Based on sev­er­al sur­veys we did dur­ing the cam­paign, it’s clear that the big ma­jor­i­ty of ex­ecs in the in­dus­try were op­posed to a Trump pres­i­den­cy. But a stock ral­ly af­ter the elec­tion and an up­beat at­ti­tude about a sup­port­ive pol­i­cy — with­out any new hints about Medicare ne­go­ti­a­tions on drug prices or reim­por­ta­tion — has start­ed to turn the tide in his fa­vor. Bio­phar­ma may nev­er love Trump, but the in­dus­try is start­ing to like what lit­tle it’s seen so far.

 

8. Al­ny­lam shares crater af­ter tri­al deaths force in­ves­ti­ga­tors to scrap PhI­II RNAi drug

Any­time a promi­nent com­pa­ny gets hit with an un­ex­pect­ed dis­as­ter, like this one at Al­ny­lam, it tends to raise big­ger ques­tions. Did the fail­ure of one drug have im­pli­ca­tions for the pipeline? How about ri­vals? How did it get this far? Al­ny­lam tried might­i­ly to put the col­lapse of its late-stage ef­fort in­to a more com­fort­ing con­text, but the de­ci­sion to halt the pro­gram clear­ly rat­tled in­vestors. Now any new hint of trou­ble is like­ly to get the spot­light of care­ful at­ten­tion, along with a bliz­zard of mixed com­ments on Twit­ter.

 

9. It’s over: Eli Lil­ly shares tank af­ter its huge gam­ble on Alzheimer’s drug solanezum­ab ends in fail­ure

Give Eli Lil­ly points for try­ing. But be sure to deduct a few for re­fus­ing to ad­mit de­feat. When you run a huge Phase III study and your drug flops, maybe it’s time to walk away. For Eli Lil­ly, though, there was enough clin­i­cal ev­i­dence of suc­cess to war­rant an­oth­er mon­u­men­tal­ly ex­pen­sive ef­fort. CEO John Lech­leit­er has al­ready timed his de­par­ture, so you can’t say he re­signed over this mess. But this is one black eye that will cause more ex­ecs to be more care­ful about how they spend their in­vestors’ mon­ey. So­la at best may have turned in­to a weak but mar­ketable drug. Its loss shouldn’t be mourned. We’re bet­ter off look­ing at bet­ter al­ter­na­tives in the pipeline. And maybe now com­pa­nies will stop tout­ing their prospects to the press. Pa­tients don’t need to be giv­en false hope. This is a ter­ri­ble, tough dis­ease. And for the past decade, all in­ves­ti­ga­tors have ex­pe­ri­enced when it comes to ac­tu­al­ly slow­ing this dis­ease is de­feat.

 

10. Clin­ton cam­paign staff: “We have start­ed the war with phar­ma!!”

Cred­it where it’s due. End­points News‘ Shehla Shakoor re­al­ly got in­to search­ing the Wik­iLeaks col­lec­tion of emails from the Clin­ton cam­paign, and she found a re­al eye-open­er in this one. It turns out that Clin­ton’s care­ful­ly aimed barb at Mar­tin Shkre­li was part of a care­ful­ly cal­i­brat­ed plan to spot­light her pledge to rein in drug prices and bad ac­tors like Shkre­li. And se­nior staffers were ready to do a high-five as the mar­kets made quite a to-do over the Twit­ter af­fair. In­ter­est­ing­ly, ab­solute­ly noth­ing came out of the hub­bub. No one reined in Tur­ing or its big price hike. Shkre­li was in­dict­ed on un­re­lat­ed charges and Clin­ton lost. But the po­lit­i­cal war with phar­ma goes on.


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Tillman Gerngross, Adagio Therapeutics CEO

An­ti­body leg­end Till­man Gern­gross is el­bow­ing his way in­to the Covid-19 R&D cru­sade: 'I don’t see this end­ing any­time soon'

One of the most influential — and outspoken — scientists at work in the field of antibody discovery is jumping into the frenzied race to create new therapeutics to treat and prevent Covid-19. And he’s operating with the conviction that the current outbreak now once again spreading like wildfire will create plenty of demand for what he has in mind.

Dartmouth professor and Adimab CEO Tillman Gerngross tells me he’s raised $50 million from a group of close VCs to spin out a new company — Adagio Therapeutics — with a full C-suite team assembled to hire up a staff and keep rolling toward the clinic.

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Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

GSK’s Shin­grix leader Guil­laume Pfe­fer has jumped on board Flag­ship to helm a biotech hy­brid as Afeyan’s lat­est CEO-part­ner

After spending 4 years in a senior post with GlaxoSmithKline’s star team positioning Shingrix for a blockbuster approval, Guillaume Pfefer is headed back to the biotech world — in style.

Pfefer has signed on to join Noubar Afeyan’s busy group of partners at Flagship, and he’s taking the helm of an upstart — which today is being merged with another Flagship startup — with some grand plans of its own. The announcement this morning notes that Pfefer will run Kintai Therapeutics, one of the grads of the Flagship labs.

Mer­ck KGaA takes its I/O op­tion on F-star Ther­a­peu­tics; Nephron spends $215M, eye­ing spot in Covid-19 vac­cine chain

→Merck KGaA has taken an early option on an immuno-oncology program developed at F-star Therapeutics. This is their second option in the collaboration. And they added a pair of preclinical discovery programs to the alliance as well.

Any biotech going public these days wouldn’t feel right if they didn’t upsize the offering. And that’s just what Phase I biotech Pandion Therapeutics did. The autoimmune company is now selling 7 million shares, a 1.5 million share bump, for $16 to $18 a share.

Full Bril­in­ta study re­sults show the blood thin­ner re­duces rate of sec­ondary stroke

AstraZeneca once projected its Brilinta drug to peak at $3.5 billion in sales, and though the blood thinner never reached that lofty goal, it received the latest positive signs in a string of recent good news.

The pharma released full details from its THALES study Thursday morning, which measured the effects of Brilinta and aspirin against aspirin alone in treating patients who had an acute ischemic stroke or transient ischemic attack. When taken twice daily with once-a-day aspirin for 30 days, the Brilinta combo reduced the risk of stroke and death by 17 percent, meeting the primary endpoint of the study.

Norbert Bischofberger, Kronos CEO

Gilead­'s ex-R&D chief Bischof­berg­er heads back to the biotech gi­ant to pick up a pair of late-stage drugs that had been put aside

Norbert Bischofberger knows entospletinib well.

Back during his long, blockbuster run as head of R&D at Gilead, researchers had once held some high hopes for this drug. But to make it work, he and the team felt it would need a new companion diagnostic to identify patients. There was talk of a combo approach to give it more punch. But the market was small, making them wonder if it would be worth going through a lengthy development cycle to get it through a pivotal.

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The $1B Mer­ck-Bay­er drug that di­vid­ed car­di­ol­o­gists in March gets pri­or­i­ty re­view

Three months after Merck published in the New England Journal of Medicine data that left doctors and investors divided over just how well its experimental heart drug worked, the FDA has handed that drug priority review. A decision is now due by January 20, 2021.

Merck first announced the drug, known as vericiguat, as a Phase III success last November. In 2016, Merck had paid $1 billion upfront for US rights to the Bayer-developed drug. Early projections foresaw a few hundred million a year in sales, but the unspecified late-stage success raised the possibility for far more. After all, Novartis’s flagship heart drug, Entresto, was earning $1.7 billion per year and was expected to reach up to $4 billion in annual sales.