The top 10 sto­ries from End­points News in 2018

We’ll end this year with a look back at the 10 sto­ries our au­di­ence found most in­ter­est­ing, based on web traf­fic. It’s al­ways fas­ci­nat­ed me when one of our sto­ries gets a vi­ral boost. This year we had a world-class scan­dal that fac­tored in, sev­er­al moves by Big Phar­ma to ex­it key re­search are­nas and some up-and-com­ing in­dus­try play­ers who made the kind of news that at­tract­ed wide­spread at­ten­tion.

One steady theme: Read­ers are in­ter­est­ed in peo­ple now more than mon­ey. Yes, what bleeds still of­ten leads, and there are plen­ty of things that are in des­per­ate shape in this in­dus­try. But a come-from-be­hind suc­cess sto­ry will at­tract a block­buster crowd, too.

The top 10 list this year is par­tic­u­lar­ly in­ter­est­ing to me be­cause we’ve seen a ris­ing tide of ac­tiv­i­ty in bio­phar­ma as new com­pa­nies spring up and go pub­lic faster than ever be­fore. There’s just a lot more R&D-re­lat­ed news these days, so get­ting to the top is hard­er.

And with­out more ado, here’s the top 10.

1 No­var­tis sac­ri­fices its top at­tor­ney in an at­tempt to quell clam­or over $1.2M in Co­hen pay­ments — while ex-CEO Jimenez strug­gles to ex­plain

It’s not of­ten that the head­lines at End­points News re­flect the hur­ley bur­ley of 24/7 ca­ble news cov­er­age. But with Don­ald Trump in the White House, any­thing is pos­si­ble. So it was as No­var­tis $NVS grap­pled with a glob­al up­roar that fol­lowed the rev­e­la­tion that it had qui­et­ly paid Don­ald Trump’s per­son­al lawyer Michael Co­hen more than a mil­lion dol­lars — fun­neled in­to the same busi­ness ac­count that cov­ered mon­ey paid out to porn ac­tress Stormy Daniels fol­low­ing her al­leged af­fair with the pres­i­dent. Hush mon­ey she called it. Now Co­hen is go­ing to jail for the pay­outs while No­var­tis and ex-CEO Joe Jimenez like to call this one over and done with. For No­var­tis, which has been mired in a se­ries of ethics scan­dals, the Co­hen up­roar has to mark a low point. And it def­i­nite­ly left a per­ma­nent mark.

No­var­tis sac­ri­fices its top at­tor­ney in an at­tempt to quell clam­or over $1.2M in Co­hen pay­ments — while ex-CEO Jimenez strug­gles to ex­plain

2 Phar­ma’s bro­ken busi­ness mod­el: An in­dus­try on the brink of ter­mi­nal de­cline

Kelvin Stott put his fin­ger right on one of the sor­est spots in the in­dus­try with this lengthy con­tributed col­umn. Big Phar­ma spends bil­lions on R&D but is steadi­ly los­ing the war on in­no­va­tion. Re­turns from their in­vest­ments have been shrink­ing for years. And Stott came up with his own math to high­light what he called a drift to the brink of ter­mi­nal de­cline. Iron­i­cal­ly, the R&D cri­sis is reach­ing the brink at a time the ma­jors are un­der tremen­dous pres­sure to cap prices, re­mov­ing the an­nu­al hikes that have fu­eled steadi­ly ris­ing rev­enue num­bers for many. They will now be forced to re­ly on their own abil­i­ty to cre­ate a block­buster pipeline, or buy one, be­cause these num­bers from Stott don’t work in the long run.

Phar­ma’s bro­ken busi­ness mod­el: An in­dus­try on the brink of ter­mi­nal de­cline

3 Pfiz­er is ax­ing its neu­ro­sciences di­vi­sion, lay­ing off 300 and dis­card­ing new drugs

None of the Big Phar­ma’s are ever quite fin­ished with re­align­ing their core R&D fo­cus­es, as we’ve seen re­cent­ly at Glax­o­SmithK­line. But af­ter years of heavy in­vest­ments with noth­ing to show for it, Pfiz­er $PFE still man­aged to shock every­one with its abrupt ex­it out of neu­ro­sciences. And true to form, the phar­ma gi­ant sim­ply took out the ax and cut the di­vi­sion out. Can­cer has been a much more lu­cra­tive are­na for Pfiz­er. Maybe they will get back in­to neu­ro some day, when peo­ple ac­tu­al­ly fig­ure out how to make new drugs for the field. In the mean­time, their de­par­ture un­der­scores the harsh re­al­i­ties of R&D. At some point, you have to put up or stop do­ing the work.

Pfiz­er is ax­ing its neu­ro­sciences di­vi­sion, lay­ing off 300 and dis­card­ing new drugs

4 CRISPR pi­o­neer Feng Zhang co-founds a ‘lim­it­less’ biotech up­start with big plans for speed­ing new drug de­vel­op­ment

Just about any sto­ry on CRISPR tech­nol­o­gy could get eye­balls this year. The promise of gene edit­ing as a new tool for tack­ling dis­ease has fas­ci­nat­ed every­one in and out­side the in­dus­try for years. And when one of the field’s founders, the Broad’s Feng Zhang, backs a start­up, you can ex­pect the news will turn heads. The mon­ey in­volved was rel­a­tive­ly small, on­ly $15.6 mil­lion. But peo­ple are more im­por­tant than mon­ey in at­tract­ing an au­di­ence. Zhang has been at the cen­ter of a bit­ter patent dis­pute in­volv­ing the pi­o­neers in this field. But he al­ways main­tained that the field was still in its in­fan­cy, with much more work to be done re­fin­ing and im­prov­ing the tech­nol­o­gy. You can ex­pect more head­lines from Zhang in the year ahead. 

CRISPR pi­o­neer Feng Zhang co-founds a ‘lim­it­less’ biotech up­start with big plans for speed­ing new drug de­vel­op­ment

5 No­var­tis joins the Big Phar­ma ex­o­dus out of an­tibi­otics, dump­ing re­search, cut­ting 140 and out-li­cens­ing pro­grams

Think neu­ro is tough? Try mak­ing com­mer­cial sense out of an­tibi­otics. The R&D work is high risk and the mar­ket, dom­i­nat­ed by cheap gener­ics, looks ex­treme­ly low mar­gin. That’s not the kind of pro­file that Big Phar­ma ever en­joyed. One of the big sur­pris­es here is that No­var­tis was still di­rect­ly en­gaged in the re­search work, while most of the ma­jors had bowed out long ago. Pub­lic health of­fi­cials glob­al­ly have been sound­ing the alarm about drug-re­sis­tant pathogens, rais­ing a hue and cry for new an­tibi­otics. But un­til the mon­ey starts to look at­trac­tive, there won’t be near­ly enough R&D work done to avert a grow­ing threat. Some­thing needs to change, but it nev­er does.

No­var­tis joins the Big Phar­ma ex­o­dus out of an­tibi­otics, dump­ing re­search, cut­ting 140 and out-li­cens­ing pro­grams

6 Ax­o­vant: That pos­i­tive p-val­ue we re­port­ed yes­ter­day? Um, we screwed that up too

Ax­o­vant $AX­ON had been try­ing to find a sil­ver lin­ing around the time that its Alzheimer’s drug blew up in Phase III when they stum­bled — bad­ly — on this mon­u­men­tal screwup. Who­ev­er did the num­bers for this par­tic­u­lar p-val­ue failed to dou­ble check the math, and a com­pa­ny that al­ready had egg on its face had to awk­ward­ly walk it back a day lat­er. Built by Vivek Ra­maswamy and then helmed by David Hung, Ax­o­vant ul­ti­mate­ly had to lev­el the pro­grams for its first two drugs and start all over again as a gene ther­a­py com­pa­ny un­der new man­age­ment. But this is the kind of cau­tion­ary tale that should in­spire every­one to make ab­solute­ly cer­tain not to get slop­py with da­ta. Some things re­al­ly are in­ex­cus­able. 

Ax­o­vant: That pos­i­tive p-val­ue we re­port­ed yes­ter­day? Um, we screwed that up too

7 Stormy Daniels’ lawyer: No­var­tis made $400K in ‘sus­pi­cious’ pay­ments to Trump at­tor­ney Michael Co­hen

This was the sto­ry that got me start­ed on the role No­var­tis had to play in the epic Stormy Daniels saga. Of course, the mon­ey was big­ger than ini­tial­ly re­port­ed, and No­var­tis CEO Vas Narasimhan hun­kered down in Basel to wait out the storm as com­pa­ny ex­ecs point­ed the fin­ger at the re­cent­ly de­part­ed Joe Jimenez for his role in mak­ing it hap­pen. No­var­tis in­sist­ed the con­tact with Co­hen was dra­mat­i­cal­ly short lived, but a probe by Sen­ate De­moc­rats reached a dif­fer­ent con­clu­sion. Scan­dals tend to linger in phar­ma­land long af­ter the head­lines are for­got­ten. Here’s an­oth­er one. 

Stormy Daniels’ lawyer: No­var­tis made $400K in ‘sus­pi­cious’ pay­ments to Trump at­tor­ney Michael Co­hen

8 Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

Here’s an­oth­er top sto­ry of the year that un­der­scores a ma­jor theme for the year. Af­ter watch­ing Bris­tol-My­ers Squibb $BMY take a com­mand­ing lead on the PD-1 front, Mer­ck’s R&D team $MRK un­der Roger Perl­mut­ter ex­e­cut­ed a mas­sive R&D ef­fort to catch up. Their prime strat­e­gy was a com­bi­na­tion of Keytru­da with chemo, while oth­ers went with CT­LA-4. Chemo won and over the course of 2018 Mer­ck caught up and then passed Bris­tol-My­ers as the leader in mar­ket­ing check­points for non-small cell lung can­cer. Mer­ck now has hun­dreds of tri­als un­der­way to help main­tain its mo­men­tum. Bris­tol-My­ers may have won the first bat­tle, but now the war is go­ing Mer­ck’s way.

Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

9 Back­ers of Tes­la and SpaceX fund 29-year-old Al­ice Zhang’s AI-pow­ered neu­ro­science start­up

In an in­dus­try that heaps praise on the el­der states­men, it’s the up-and-com­ers like Al­ice Zhang — just like Feng Zhang — that read­ers grav­i­tate to­ward the most. A new name and a new tech­nol­o­gy like AI is all but as­sured wide at­ten­tion. There are no sure things in bio­phar­ma, of course, and new tech­nolo­gies com­mon­ly take years be­fore they tru­ly re­veal their po­ten­tial for dis­rup­tion. But the Cal­i­for­nia dream­ers are get­ting their shot.

Back­ers of Tes­la and SpaceX fund 29-year-old Al­ice Zhang’s AI-pow­ered neu­ro­science start­up

10 The un­der-40s: How does the next gen­er­a­tion of bio­phar­ma ex­ec­u­tives view the fu­ture?

Just to dri­ve that point about new faces and new tech­nol­o­gy home for you, our fi­nal piece for this year’s top 10 fea­tured some of the most promi­nent younger ex­ecs on the way up the lad­der in bio­phar­ma. You can see for your­self who made the first list. We’ve al­ready be­gun to plan for our sec­ond look in 2019, so be sure to keep a look­out when we ask for nom­i­na­tions. Peo­ple care. It’s im­por­tant.

The un­der-40s: How does the next gen­er­a­tion of bio­phar­ma ex­ec­u­tives view the fu­ture?


Im­age: SHUT­TER­STOCK

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.