An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

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.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,300+ biopharma pros reading Endpoints daily — and it's free.

Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.