What is End­points?

Let me start by out­lin­ing a few things we’re not do­ing.

We’re not an­oth­er ag­gre­ga­tion ma­chine. There are plen­ty of places that will give you a quick and ster­ile snap­shot of the bio­phar­ma R&D world. And that’s not us.

We’re not the AP or any oth­er wire ser­vice. There’s al­ready an AP, Reuters, Bloomberg, and they do a fine job. That job is cov­ered.

We’re not stock pick­ers. Frankly, we wouldn’t know where to be­gin.

Many of you may know Pub­lish­er Ar­salan Arif and I from an ear­li­er com­pa­ny we worked at.

We’re not that com­pa­ny, ei­ther.

So what are we?

We’re a deeply ex­pe­ri­enced team of own­er/ed­i­tors that has spent more than a decade learn­ing about glob­al drug de­vel­op­ment and dig­i­tal me­dia. We aim to put that ex­pe­ri­ence, and the con­tacts we’ve de­vel­oped in-per­son and on­line to work for you; an­a­lyz­ing in­dus­try news for in­dus­try pro­fes­sion­als, pro­vid­ing the da­ta and in­for­ma­tion need­ed to in­tel­li­gent­ly as­sess where the bio­phar­ma re­search in­dus­try is head­ed.

Yes, in ad­di­tion to break­ing sto­ries and plen­ty of en­tire­ly orig­i­nal con­tent, we will al­so source pubs around the globe in pur­suit of a big goal. But we will al­ways put the news in con­text. And we will al­ways cut to the chase. That’s our se­cret sauce. And it’s some­thing that can’t be cloned.

Over the past two years, Ar­salan has been de­vel­op­ing a new dig­i­tal news plat­form that em­ploys its own orig­i­nal ap­proach to high­light­ing the re­ports from around the globe that mat­ter most. That’s our Ear­ly Edi­tion, which he ham­mers away at dur­ing predawn hours. And he al­so has an en­ter­tain­ing/in­sight­ful col­lec­tion of links to the most sought-af­ter con­tent, ranked by Twit­ter pop­u­lar­i­ty.

You’ll find Ar­salan and I again in our main edi­tion at noon EST (pub time, Lon­don; Star­bucks time, San Fran­cis­co; the mid­night spe­cial in Shang­hai), pro­vid­ing an an­a­lyt­i­cal, da­ta dri­ven dai­ly re­port on the drug R&D world. I’ll spend my day fo­cused on in­ter­pret­ing the top news and pro­vid­ing a da­ta-dri­ven set of an­a­lyt­ics specif­i­cal­ly for bio­phar­ma pro­fes­sion­als. Go to endpts.com to catch the live stream, as I pur­sue a re­al-time con­ver­sa­tion with read­ers.

On­line fi­nan­cial news hasn’t just cre­at­ed a new out­let for me­dia. It’s fun­da­men­tal­ly de­mand­ed a new style that re­quires a lot of hands-on ex­pe­ri­ence.

That’s who we are.

It won’t all be 100% fin­ished. We’ll prob­a­bly nev­er be 100% done with any­thing. The busi­ness we’re in is chang­ing in ex­plo­sive ways. We’ll try to keep up, some­times we may try to lead.

If you’ve got ques­tions, drop me a line. The best way to un­der­stand is to read one of our re­ports.

We hope you sub­scribe and stay with us for this ride. We’ll work for it.

— John Car­roll   john@end­pointsnews.com

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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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

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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