End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

End­points News turned five years old over the week­end. I want­ed to mark the hap­py oc­ca­sion by ex­tend­ing our deep­est grat­i­tude to End­points’ pre­mi­um sub­scribers while out­lin­ing sev­er­al oth­er ways to sup­port us as we go broad­er and get big­ger this year and be­yond.

Same as any busi­ness, we’ve got to cre­ate val­ue and get paid for de­liv­er­ing it. So if you de­pend on End­points to stay abreast on bio­phar­ma de­vel­op­ments, we de­pend on you too.

The best way to sup­port us is by up­grad­ing to a pre­mi­um sub­scrip­tion. It’s our most im­por­tant source of rev­enue be­cause it ties our ed­i­to­r­i­al in­cen­tives di­rect­ly to read­er ex­pec­ta­tions — fo­cus­ing on qual­i­ty over quan­ti­ty. We work to de­liv­er some­thing worth pay­ing for every day. Not just an­oth­er email clog­ging your in­box.

We have two plans: In­sid­er for in­di­vid­u­als ($225/year) and En­ter­prise for com­pa­nies ($1,000/year). Both of them un­lock the com­plete End­points ex­pe­ri­ence and con­tent li­brary. The En­ter­prise plan is a flat rate that cov­ers all em­ploy­ees, and you don’t need to ne­go­ti­ate rates with us or pick who on your team gets ac­cess. Every­one does. Check out our en­tire pre­mi­um cat­a­log here.

And if you have ques­tions, our cus­tomer ser­vice team is quick to re­spond — you can chat with them here.

This year we launched three new ti­tles. End­points FDA+ and End­points Man­u­fac­tur­ing — spear­head­ed by se­nior ed­i­tor Zachary Bren­nan and man­ag­ing ed­i­tor Kyle Blanken­ship, re­spec­tive­ly — is your one-stop look at the most crit­i­cal de­vel­op­ments in those fields and what they mean for bio­phar­ma. And se­nior ed­i­tor Am­ber Tong is be­hind our new End­points Week­ly, which re­caps the busy week in bio­phar­ma every Sat­ur­day morn­ing. You can add these ti­tles to your sub­scrip­tion by vis­it­ing your Read­er Pro­file, or if you’re new to End­points, via our sign-up page.

If a pre­mi­um sub­scrip­tion isn’t in the cards yet, but you’d still like to sup­port us, please help spread the word and share End­points with your col­lab­o­ra­tors. Noth­ing is bet­ter than re­fer­rals, and it’s where we get most of our new sub­scribers. Just share our URLs and for­ward our email re­ports to your col­leagues. Most End­points cov­er­age is free to read, with no pay­ment re­quired for a ba­sic sub­scrip­tion.

We’ve al­so spent the past five years op­ti­miz­ing our ad­ver­tis­ing prod­ucts. So for mar­ket­ing lead­ers who need to reach ei­ther a large or tar­get­ed au­di­ence in the life sci­ences, we’d love to talk.

End­points is dif­fer­ent in that we in­ten­tion­al­ly keep ad­ver­tis­ing space tight. That helps pop the brand ad­ver­tis­ing cam­paigns on our site. It re­duces spon­sor­ship fa­tigue from the read­ers and in­creas­es con­ver­sions. Our chief rev­enue of­fi­cer Mike Peck has built a sales team where re­la­tion­ships mat­ter most. We’re in­ter­est­ed in get­ting more from clients who see ex­cel­lent re­sults with us, not milk­ing every deal for pen­nies. And End­points’ cus­tomer ser­vice, led by our tal­ent­ed COO Shelly Whit­field, is sec­ond-to-none. Her team works to ex­e­cute cam­paigns for 200+ ad­ver­tis­ing clients, and they do great work.

Af­ter five years in busi­ness, we’ve grown to 32 full-time em­ploy­ees with more on the way. 100,000+ in­dus­try pros get our news di­rect­ly in their in­box dai­ly. Dur­ing the pan­dem­ic, our vir­tu­al events at­tract­ed 32,000 at­ten­dees. And yet, End­points’ mis­sion hasn’t changed since day one: In­form and con­nect the bio­phar­ma world with re­lent­less dai­ly re­port­ing.

To all of our cur­rent pre­mi­um sub­scribers who’ve di­rect­ly fund­ed our growth: Thank you. Get­ting to this mile­stone was im­pos­si­ble with­out your sup­port. To every­one who is con­sid­er­ing get­ting one to­day for them­selves or their com­pa­ny: We’ll work hard to con­tin­ue earn­ing your sup­port every day.

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.