Endpoints News Executive Editor Drew Armstrong

What's next at End­points: a big­ger, more am­bi­tious news­room

I’ve had a lit­tle over a month in the Ex­ec­u­tive Ed­i­tor seat here at End­points News, and I want to take a mo­ment to in­tro­duce my­self to this great com­mu­ni­ty of read­ers and talk about where we’re head­ed next.

For the last 20 years, I’ve been lucky to cov­er some of the biggest sto­ries in health­care. I had a front-row seat on Capi­tol Hill for the Af­ford­able Care Act, wrote the first sto­ries about our cur­rent drug price de­bate, and spent three years lead­ing projects on the Covid-19 pan­dem­ic. Dur­ing that time, we’ve wit­nessed amaz­ing ad­vances in the treat­ment of can­cer, the ma­nip­u­la­tion of ge­net­ics and our un­der­stand­ing of hu­man bi­ol­o­gy.

I came to End­points be­cause those sto­ries are on­ly get­ting more com­plex, ask­ing more from jour­nal­ists, and hope­ful­ly of­fer­ing more to read­ers.

The fu­ture of End­points, and much of news me­dia, is in that com­plex­i­ty. “Trade jour­nal­ism” for me has al­ways been a mis­lead­ing and un­der-am­bi­tious de­scrip­tion of what we do. I pre­fer the term “spe­cial­ty jour­nal­ism.” We’re a news­room of ex­perts fo­cused on the bio­phar­ma in­dus­try – with the abil­i­ty and am­bi­tion to com­pete with (and beat!) the biggest pub­li­ca­tions for scoops and smart analy­sis on our turf.

To that end, we’re hir­ing: To­day we’ve post­ed six new jobs at End­points that will ex­pand the size and am­bi­tion of our news­room. You can find the list­ings here (along with de­scrip­tions of our great ben­e­fits and our work-from-home/any­where pol­i­cy). We’re adding to our edit­ing ranks, and plan to hire writ­ers and re­porters to boost our sci­ence, ven­ture cap­i­tal and reg­u­la­to­ry cov­er­age.

We want peo­ple who are pas­sion­ate about cov­er­ing med­ical in­no­va­tion and busi­ness, but al­so who see the jour­nal­ism world the way we do: who be­lieve that fo­cus cre­ates great­ness, and that the next thriv­ing news­rooms will be built by be­ing smarter and break­ing more news than any­one else on your beat.

The amaz­ing writ­ers and ed­i­tors in this news­room have made End­points in­to the first read for de­ci­sion-mak­ers in the bio­phar­ma world. As we ex­pand, we’re go­ing to de­liv­er more scoops, more ex­clu­sive news, more smart per­spec­tive, and more ideas and re­port­ing that you can’t get any­where else.

As found­ing ed­i­tor John Car­roll men­tioned in his note in No­vem­ber, this will al­so al­low him to spend more time writ­ing, in­ter­view­ing and grow­ing our busi­ness. You can ex­pect to hear more from John over the com­ing months, as well as from the new voic­es that we’re ex­cit­ed to add.

Since I start­ed ex­plor­ing this job ear­ly in 2022, I’ve al­so been able to talk to many of you about what you read and how you read it. There are more changes ahead as we think about how to de­liv­er news that makes the best use of our read­ers’ time, with the depth, analy­sis and se­ri­ous­ness they need.

As we make those changes, we want to hear from you. If you’ll be at JP Mor­gan next month, please stop in at our End­points event and say hel­lo.

Thank you for read­ing, sub­scrib­ing, and sup­port­ing us – I can’t wait to start show­ing you what this great news­room has com­ing!

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.