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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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; 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.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ap­proach­es

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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