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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The fire­hose of bio­phar­ma news is gush­ing these days.

That’s why broad­er and deep­er is the theme for 2021 at End­points. You can ex­pect new cov­er­age out­side our core R&D fo­cus, with deep­er re­port­ing in some key ar­eas. When John Car­roll and I launched End­points near­ly five years ago, we were wad­ing in waist-high wa­ters. Now we’re a team of 25 full-time staffers (and grow­ing) with plans to cov­er the flood of bio­phar­ma news, End­points-style.

If you re­ly on us for news, we’re go­ing to need your help.

The sin­gle best way to sup­port us is en­rolling in End­points Pre­mi­um, our an­nu­al sub­scrip­tion pro­gram that un­locks the full End­points ex­pe­ri­ence.

We of­fer two pre­mi­um plans: In­sid­er for in­di­vid­u­als and En­ter­prise for com­pa­nies.

  • En­ter­prise — $1,000/year for your en­tire or­ga­ni­za­tion, re­gard­less of size. We of­fer a rare un­lim­it­ed-seat li­cense, which makes every em­ploy­ee el­i­gi­ble for End­points Pre­mi­um. In ad­di­tion to un­lock­ing the pay­wall for all, em­ploy­ees will re­ceive a cus­tom ver­sion of the dai­ly email re­ports, sig­ni­fy­ing your com­pa­ny’s sup­port of in­de­pen­dent jour­nal­ism. You can see an ex­am­ple of that in the graph­ic above. Oth­er ben­e­fits in­clude two free pre­mi­um job list­ings at End­points Ca­reers and a reprints li­cense for shar­ing our con­tent in­ter­nal­ly any way you see fit. The ap­pli­ca­tion form is here; ac­cess is grant­ed in­stan­ta­neous­ly af­ter pay­ment. We al­so have a fan­tas­tic cus­tomer sup­port team to help you get the most from sub­scrib­ing. You can con­tact them here.
  • In­sid­er — $225/year for in­di­vid­u­als. With an In­sid­er plan, in­di­vid­ual sub­scribers have the op­tion to dis­able ad­ver­tis­ing, in ad­di­tion to un­lock­ing the con­tent li­brary. If you want just the news con­tent and noth­ing else, this is the plan for you.

Most im­por­tant­ly, with both plans, you’re di­rect­ly sup­port­ing the fu­ture de­vel­op­ment of End­points News. As an in­de­pen­dent pub­li­ca­tion, we’ve avoid­ed rais­ing cash from in­vestors. We re­port to our paid sub­scribers and no one else.

To be sure, join­ing End­points Pre­mi­um is op­tion­al. We be­lieve that high-qual­i­ty re­port­ing ought to be free and eas­i­ly ac­ces­si­ble. So we’re com­mit­ted to keep­ing the most es­sen­tial bits avail­able with our no-cost Ba­sic email sub­scrip­tion.

But as we get broad­er and deep­er in 2021, End­points Pre­mi­um is where you’ll find more of that work. So any com­pa­ny or read­er look­ing for the com­plete pic­ture should sign up for a paid plan to­day.

One ex­am­ple of the deep­er work you’ll have ac­cess to is a print­able PDF of all new drug ap­provals in 2020.

Broad­er and deep­er

We’ve got big plans to cov­er new ground and it will be­gin with a new prod­uct launch: End­points Man­u­fac­tur­ing.

Start­ing in Feb­ru­ary, every Thurs­day we’ll de­liv­er the most im­por­tant sto­ries in man­u­fac­tur­ing in one con­ve­nient email re­port. End­points re­porter Con­ner Mitchell will be lead­ing our bio­man­u­fac­tur­ing cov­er­age. It’s a crit­i­cal beat in the bio­phar­ma world and we’re dou­bling down.

Un­der the main End­points News ban­ner, our grow­ing team has af­ford­ed us op­por­tu­ni­ties to go deep­er, too.

We’re do­ing more pre­clin­i­cal sto­ries and phar­ma news too, break­ing ex­clu­sives, and pick­ing more spots to re­port sci­ence news.

Some­times, it’s in the form of In Fo­cus pieces, like Ja­son Mast’s ex­plo­ration in­to a med­ical mys­tery be­hind a gene ther­a­py tri­al. It’s al­so in the End­points 11, where John Car­roll pro­filed eleven of bio­phar­ma’s most promis­ing star­tups in Sep­tem­ber. We went be­yond write-ups and de­liv­ered lengthy video in­ter­views with the win­ners at our vir­tu­al event, and there’s a trea­sure trove of knowl­edge to un­cov­er in these con­ver­sa­tions. It’s a must-watch if you’re in­to biotech en­tre­pre­neur­ship.

That same de­tail went in­to Women in Bio­phar­ma, our De­cem­ber vir­tu­al event. Here you saw con­tri­bu­tions from our en­tire team, led by ed­i­tors Am­ber Tong and Nicole De­Feud­is. I con­sid­er it some of our best work. If you haven’t yet, please take a few min­utes to watch the videos of our hon­orees. It’s a rare treat to hear and learn from these lu­mi­nar­ies di­rect­ly.

We’re go­ing to be do­ing much more of that in 2021.

For cur­rent End­points Pre­mi­um sub­scribers, thank you — there’s no chance we’d be here to­day with­out you. For those of you get­ting one to­day, be sure that we have nev­er been more ap­pre­cia­tive of your sup­port for the in­de­pen­dent mis­sion we have carved out for our­selves as we boot­strapped this start­up.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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Andy Jassy, Amazon CEO (Isaac Brekken/AP Images for NFL, File)

Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Center for Drug Evaluation and Research on Tuesday released a warning letter sent last week to Amazon CEO Andy Jassy in Seattle for selling mole removal products over-the-counter, or, as the FDA explains, “introducing, delivering, or causing the introduction or delivery into interstate commerce of products that are unapproved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legally sold for mole or skin tag removal, and FDA has safety concerns about drugs marketed OTC directly to consumers for these uses,” the agency said in its Aug. 4 warning.

Craig Thompson, Cerevance CEO

UP­DAT­ED: Mer­ck makes first big splash for Alzheimer’s drug R&D since 2017 fail, ink­ing re­search pact with Cere­vance

For the first time since discontinuing its late-stage Alzheimer’s program, Merck has found promise on the path forward in the memory-robbing disease.

After a Phase III flop of its drug verubecestat, the New Jersey Big Pharma axed the study in early 2018. More than four years later, the company is ready to sign up for another pact to test the waters of the befuddling disease.

This time, there’s $1.1 billion in biobucks on the line and a target that its partner says no other biopharma is looking at en route to finding the next treatment for Alzheimer’s, a neuroscience field that has hit hurdle after hurdle for decades.

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