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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.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

What con­tro­ver­sy? Eli Lil­ly plots Alzheimer's BLA fil­ing lat­er this year as FDA taps more an­ti-amy­loid drugs as break­throughs

The FDA is keeping the good news coming for Alzheimer’s drug developers. And Eli Lilly is taking them up on it.

Amid continued controversy around whether Biogen’s new flagship drug, Aduhelm, should have been approved at all — and swelling, heated debates surrounding its $56,000 price tag — the agency had no issue handing them and their Japanese partner Eisai a breakthrough therapy designation for a second anti-amyloid beta antibody, lecanemab, late Wednesday.

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Hervé Hoppenot, Incyte CEO (Jeff Rumans)

ODAC echoes FDA con­cern over In­cyte PD-1, as Paz­dur sig­nals broad­er shift for ac­cel­er­at­ed ap­proval

After the FDA lambasted their PD-1 ahead of an adcomm earlier this week, Incyte ran into new trouble Thursday as ODAC panelists voted against an accelerated OK by a wide margin.

Members of the Oncologic Drugs Advisory Committee recommended with a 13-4 vote to defer a regulatory decision on Incyte’s retifanlimab until after more data can be collected from a placebo-controlled trial. The PD-1 therapy is due for a PDUFA date in late July after receiving priority review earlier this year.

New FDA doc­u­ments show in­ter­nal dis­sent on Aduhelm ap­proval

In a lengthy review document and a pair of memos from top officials, the FDA released on Tuesday night its most detailed argument yet for approving Biogen’s intensely controversial Alzheimer’s drug aducanumab.

The documents amount to an agency attempt to quench the firestorm their decision kindled, as outside advisors members resigned and experts warned that an unproven drug now could stretch Medicare’s budget to a breaking point. Ultimately, the documents show how CDER director Patrizia Cavazzoni and Office of New Drugs director Peter Stein both concurred with FDA neuroscience head Billy Dunn on the accelerated approval while the staff at FDA’s Office of Biostatistics did not think an approval was warranted.

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Karen Flynn, Catalent

Q&A: When the pan­dem­ic struck, Catal­en­t's CCO had just joined the team

Karen Flynn came aboard Catalent’s team just in time.

The company was going through a surge of changes, and she had been brought over from her role as CCO of West Pharmaceutical Services to serve in the same capacity for the New Jersey-based CDMO. Then a few months later, the pandemic was in full-force.

Since then, Catalent’s been in hyper-expansion mode. In early May, it acquired Promethera’s Hepatic Cell Therapy Support SA subsidiary and its 32,40-square-foot facility in Gosselies, Belgium. Prior to that, the company acquired Belgian CDMO Delphi Genetics, wrapped up the expansion of an already-existing site in Madison, WI and added an ultra-low temperature freezer partner in Sterling. As Emergent has botched millions of doses of AstraZeneca’s vaccine, the company has swooped in to move that production to its Maryland plant as well.

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Richard Pazdur (vis AACR)

FDA en­cour­ages in­clud­ing in­cur­able can­cer pa­tients in tri­als, re­gard­less of pri­or ther­a­pies

The FDA on Thursday called to include those with incurable cancers (when there is no potential for cure or for prolonged/near normal survival) in appropriate clinical trials, regardless of whether they have received existing alternative treatments.

Historically, many cancer clinical trials have required that participating patients previously received multiple therapies, according to Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

On heels of Aduhelm ap­proval, Bris­tol My­ers jumps back in­to Alzheimer's race

Bristol Myers Squibb last put major resources behind an Alzheimer’s drug nearly a decade ago, when their own attempt at targeting amyloid flamed out in mid-stage studies. They invented another molecule, a Tau-targeted antibody, but jettisoned it to Biogen in 2017 as they dropped out of neuroscience altogether.

But on Thursday, the New York pharma announced they were getting back in the game. Bristol Myers exercised an $80 million option to bring a tau-targeted antibody from Prothena into a Phase I study. The opt-in, which Bristol Myers triggered ahead of analyst expectations, opens the door for another $1.7 billion in milestones down the road.

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James Peyer, Cambrian

Can a cell ther­a­py treat mus­cu­lar dy­s­tro­phy? A Ger­man bil­lion­aire's an­ti-ag­ing start­up is try­ing to find out

Gene therapy companies have faced huge hurdles trying to deliver healthy genes into muscular dystrophy patients’ muscle cells, so here’s an idea: Why don’t we just replace the muscle cells themselves?

Over the last two years, Vita Therapeutics has been exploring that possibility, building on early stem cell work from Johns Hopkins professor Peter Andersen. And on Tuesday they announced a $32 million Series A to begin to move their first therapy into the clinic, where they hope it will help rebuild muscle in patients with a type of dystrophy that afflicts the arms and legs.

Alexis Borisy (file photo)

EQRx and Ex­sci­en­tia, a pair of self-styled dis­rup­tors, team up to over­turn the drug pric­ing ap­ple cart

The biotech industry has seen no shortage of innovation in recent years, but in one area — drug pricing — the field has been anything but innovative. Now, two brash startups taking different roads to upset the drug pricing model will partner up to create a sort of “super-disruptor.”

EQRx and UK-based AI specialist Exscientia will team up on a discovery-through-commercialization collaboration the partners hope will work better than the sum of its parts to bring cheaper medicines to patients faster, the companies said Thursday.