The busi­ness mod­el of End­points News — and why you should sub­scribe

Pisa, Italy – 2008
From the pub­lish­er

Our busi­ness mod­el is ex­pand­ing to­day. In short: you can keep read­ing us for free, but we’re adding new ben­e­fits with paid sub­scrip­tions, and not tak­ing any con­tent away. We re­main com­mit­ted to ac­ces­si­ble jour­nal­ism.  But we plan on grow­ing the group at End­points, and we’d like your sup­port for that. So we’re ask­ing read­ers — both com­pa­nies and in­di­vid­u­als — to pur­chase one of two new sub­scrip­tion prod­ucts.

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Li­cense Un­lim­it­ed cut-and-paste and reprint rights; pri­vate news­feed for com­pa­ny re­broad­cast, print to PDF, and ex­clu­sive opin­ion con­tent. The best way a com­pa­ny can sup­port End­points News. One li­cense cov­ers every em­ploy­ee no mat­ter how large or small the firm.


For over a year now, co-founder John Car­roll and I have been build­ing a busi­ness news com­pa­ny on an open mod­el be­cause we be­lieve the news ought to be free, ac­ces­si­ble, and eas­i­ly dis­cov­er­able by the right au­di­ences. Our job is to cre­ate a news­feed which bio­phar­ma read­ers seek out and will­ing­ly re­turn to.

We think 60% of you will not, un­der any cir­cum­stance, pay for con­tent. And that’s no prob­lem. We wel­come you, and noth­ing much will change.

Free sub­scribers will con­tin­ue get­ting full-fi­deli­ty Ear­ly Edi­tion and Fea­ture Edi­tion dai­ly email newslet­ters, plus up to four spon­sored emails per month, and en­joy one-click reg­is­tra­tion ac­cess to spe­cial re­ports and deep dives. This is all sup­port­ed by email mar­ket­ing cam­paigns from spon­sors who part­ner with us di­rect­ly to show you rel­e­vant cam­paigns.

For com­pa­nies and in­di­vid­u­als who want to sup­port our work, or could use the new ben­e­fits we’re in­tro­duc­ing to­day, the In­sid­er and En­ter­prise plans are for you.

Do I/we need a sub­scrip­tion? 

(1) Do you cut-and-paste lib­er­al­ly, be­yond fair use, from our web­site and share con­tent with col­leagues or with clients?

(2) Do you for­ward our emails or ar­ti­cles to a com­pa­ny-wide dis­tri­b­u­tion?

If the an­swer is yes to ei­ther, you need an En­ter­prise Plan li­cense.

The plan is made for near­ly all busi­ness pur­pos­es and in­tents. If you work in PR, me­dia mon­i­tor­ing, or ad­ver­tis­ing, and we re­port on your clients, chances are you might want to legal­ly use our con­tent to present it in your own for­mat or medi­um. This plan is for you.

If we buy an En­ter­prise Plan, does that mean every­one in my com­pa­ny is cov­ered?

Yes. Every­one in your com­pa­ny is cov­ered if just one per­son is the hold­er of a cur­rent En­ter­prise sub­scrip­tion. If you work at Mer­ck or Lemon­ade Stand Biotech, the price is the same.

Does the En­ter­prise plan in­clude every­thing the In­sid­er has?

No. The In­sid­er plan in­cludes the ad-free ex­pe­ri­ence. En­ter­prise plans on­ly in­clude it for the ac­count hold­er, but that ben­e­fit does not ex­tend to the en­tire com­pa­ny.

Why are you do­ing sub­scrip­tions? Isn’t the spon­sored con­tent busi­ness de­cent?

Top-class brands like Catal­ent, PPD, Brack­et, in­Ven­tiv Health Con­sult­ing, and more, all got on the ground floor and part­nered with us on smart, high-im­pact cam­paigns for their brands in our first year. You will be see­ing a lot more of that in the years to come be­cause it’s a cru­cial piece of our fu­ture.

Ar­salan Arif

But the truth is, no­body can tell the fu­ture of the news busi­ness, so like any good en­ter­prise, we’re di­ver­si­fy­ing our rev­enue. And for us, there can be no bet­ter rev­enue than the kind we get di­rect­ly from our au­di­ence. Our goal is to be around for a while. Noth­ing is more im­por­tant to our fu­ture than this pro­gram.

We have a few non-ne­go­tiables. Sharp writ­ing, con­sis­ten­cy, an­swer­able on­ly to read­ers, re­li­ably de­liv­ered, pre­sent­ed clean­ly — with full fi­deli­ty in email and on the web. No tech­ni­cal lim­i­ta­tions placed on read­ers. These are our prin­ci­ples.

And all of those ideals cost re­al mon­ey. We’re aware of the mar­gin­al cost of cre­at­ing con­tent on­line to­day. It’s painful­ly and ab­solute­ly ze­ro. But we think good con­tent and ideas will win, but not with­out the di­rect sup­port of our read­ers.

We’re go­ing to keep work­ing for it every day. We hope you join us.

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

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2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

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Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.

Daphne Zohar (PureTech)

PureTech bags $200M from sale of Karuna shares — still siz­zling from promis­ing schiz­o­phre­nia da­ta

Cashing in on the exuberance around Karuna Therapeutics and its potential blockbuster CNS drug, PureTech has sold a chunk of the biotech’s shares to Goldman Sachs for $200 million.

Boston-based PureTech had helped Eli Lilly vet Steve Paul launch Karuna and invent its lead program, which combines two old drugs that both act on the muscarinic receptor and balances each other out. Xanomeline, a discard from Lilly, stimulates the M1 and M4 receptors; trospium is an muscarinic receptor antagonist approved to treat overactive bladders.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

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UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

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Roche cracks Chi­na's ADC mar­ket open as Kad­cy­la scores its first breast can­cer OK in the coun­try

Roche’s Kadcyla has become the first antibody-drug conjugate to enter the Chinese market, marking a dramatic advance for both the Swiss pharma giant and the therapeutic class.

The local arm of Roche announced the approval late Tuesday, which covers the therapy’s use in the adjuvant setting in patients with early HER-2 positive breast cancer who still have residual invasive disease after receiving paclitaxel and Herceptin as neoadjuvant treatment.