End­points In­sid­er: The world’s old­est new biotech pub ends its 12th month on a roll

We’ve been watch­ing our web traf­fic grow month-to-month at a dou­ble-dig­it pace. In June, traf­fic at End­points News hit 313,439, ex­act­ly 10% high­er than the month be­fore, with 161,226 unique vis­i­tors to the site. And our sub­scriber list broke the 16,000 mark – heav­i­ly con­cen­trat­ed among bio­phar­ma ex­ec­u­tives — as we head straight to 20,000 this fall.

I like to say that End­points is the old­est new bio­phar­ma pub on the block. For those of you who have fol­lowed me over the past 15 years – in­clud­ing much of the 14 years be­fore Ar­salan Arif and I part­nered on the launch on June 20, 2016 – it’s that track record and abil­i­ty to swift­ly add con­text to the news that makes this pub dif­fer­ent from all of the rest. And as we grow the staff this sum­mer, you can bet that we’ll be look­ing to con­tin­ue to broad­en our cov­er­age base and ge­o­graph­ic reach as we look to grow the au­di­ence and web traf­fic to 500,000-plus in the near fu­ture.

What I’m par­tic­u­lar­ly hap­py about is that we ac­com­plished this with a small team and ex­act­ly noth­ing to spend on a mar­ket­ing cam­paign. All of our growth has been through word-of-mouth rec­om­men­da­tions and our so­cial me­dia pres­ence, with a big boost re­cent­ly from Google News. When you’re boot-strap­ping a new, dig­i­tal pub like this, you’ve got noth­ing ex­tra for mar­ket­ing. So we’re all ex­tra­or­di­nar­i­ly grate­ful for your sup­port and the steady stream of notes from read­ers.

This lit­er­al­ly could nev­er have hap­pened with­out your help.

To help fund the sec­ond year of growth, Ar­salan and I are prep­ping a sub­scriber cam­paign for End­points In­sid­er that will get un­der­way ear­ly next week. As we’ve al­ready made clear, we are not go­ing be­hind a pay­wall. The news will re­main on­line and eas­i­ly ac­ces­si­ble. We are look­ing for read­ers who sup­port the mis­sion, or sim­ply no longer wish to get emailed ad­ver­tis­ing, to sub­scribe to End­points for $200 a year.

Pre-reg­is­ter for End­points In­sid­er

No pay­ment de­tails re­quired to­day

There’s al­so a $1,000/per year cor­po­rate rate for groups, no mat­ter what size. That in­cludes full reprint and re­pub­lish­ing rights of our con­tent for all le­git­i­mate busi­ness cas­es — per­fect for PR agen­cies who want to send ar­ti­cles in full to clients, cor­po­rate in­tranets, trade show ad­ver­tis­ing, web­site post­ing, and more. Whether you are a multi­na­tion­al cor­po­ra­tion or a small shop, the en­ter­prise rate is the same.

We’ve had a strong re­sponse from our first word on this new cam­paign. And you can add your name to our pre­reg­is­tra­tion list here. (You won’t be billed to­day or asked to pro­vide pay­ment de­tails.)

It’s been a great start. And the rest of 2017 and all of 2018 are go­ing to be gang­busters. I guar­an­tee you won’t want to miss it. — John Car­roll

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Mer­ck sues Johns Hop­kins for li­cens­ing Keytru­da patents in se­cret and in con­flict with re­search col­lab­o­ra­tion

Merck filed a lawsuit against Johns Hopkins University in Maryland federal court on Tuesday, arguing that the storied university obtained illegal patents as part of its research collaboration with the company and related to its blockbuster cancer drug Keytruda (pembrolizumab).

Merck alleges that the Baltimore-based university obtained and licensed Keytruda-related patents in secret while claiming that Keytruda was developed before and independent of a 2013 research collaboration between the two organizations. Hopkins also sought “hundreds of millions of dollars” tied to Keytruda sales because of the patents, Merck contends.

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