One of the 100 limited-edition framed certificates we're sending to the first group of companies that signed up for an Enterprise plan

Un­lock the full End­points ex­pe­ri­ence for your com­pa­ny — and sup­port our mis­sion of in­de­pen­dent bio­phar­ma re­port­ing

I want to give read­ers a quick up­date on the most im­por­tant part of our busi­ness mod­el — pre­mi­um sub­scrip­tions. We have some cru­cial fi­nan­cial goals we hope to achieve by the end of the year, and the team here in Lawrence is ready to ship some swag to kick off this lim­it­ed De­cem­ber pro­mo­tion.

We of­fer two pre­mi­um plans — En­ter­prise for com­pa­nies ($1,000/year, un­lim­it­ed peo­ple), and In­sid­er for in­di­vid­u­als ($200/year). This month of De­cem­ber will be the last chance to en­roll at the orig­i­nal rates — which have re­mained flat since we launched them in 2017.

Both plans un­lock ac­cess to our en­tire pre­mi­um con­tent li­brary like 100 top VCs in bio­phar­ma, Re­al World End­points: the brave new world com­ing in build­ing fran­chise ther­a­pies, and the top 20 pre­clin­i­cal biotech deals, and much more. You get ac­cess to tools like down­load­ing ar­ti­cles to PDF, our VIP sup­port team, and most of all, you’re di­rect­ly fund­ing the fu­ture de­vel­op­ment of End­points. These plans have been the rea­son we’ve been able to make new ed­i­to­r­i­al hires, with more to come. And we’re adding new ben­e­fits next year: paid sub­scribers will have ex­clu­sive ac­cess to watch our an­nu­al event at JP Mor­gan live at no ad­di­tion­al cost.

  • In­di­vid­u­als — sign-up for In­sid­er. All of the ben­e­fits above plus the op­tion to dis­able all ad­ver­tis­ing across web and email, and dis­count­ed tick­ets to End­points events. $200/year, end­ing soon.
  • Com­pa­nies — sign-up for En­ter­prise. Cov­ers every­one at your or­ga­ni­za­tion for $1,000/year. In­cludes a reprint li­cense to re­pur­pose and dis­trib­ute End­points con­tent in­ter­nal­ly. All em­ploy­ees will al­so be­gin to see a new “Your com­pa­ny sup­ports in­de­pen­dent jour­nal­ism” ban­ner in their dai­ly email re­ports.

By up­grad­ing, you’re di­rect­ly sup­port­ing in­de­pen­dent bio­phar­ma re­port­ing, and we’re look­ing for ways big and small to help pro­mote that among our read­ers. And that’s where the swag comes in.

The next 100 In­sid­er ac­counts to sign-up will re­ceive these vinyl stick­ers — 4 in a se­ries — that our stu­dio cre­at­ed.

And the next new 25 En­ter­prise sub­scribers will get stick­ers plus one of these amaz­ing­ly com­fort­able hood­ies. (Our sup­port team will reach out to get your pre­ferred size!)

Fi­nal­ly, the stu­dio cre­at­ed 100 lim­it­ed edi­tion framed cer­tifi­cates in hon­or of the very first batch of com­pa­nies who signed up for the En­ter­prise plan back when we launched it in the sum­mer of 2017. You can see a copy of what they look like at the top of this post.

These sub­scrip­tion plans helped End­points scale up to where we are to­day: serv­ing 400,000 unique read­ers per month on the web and near­ly 70,000 bio­phar­ma pros dai­ly by email, sup­port­ed by a glob­al­ly dis­trib­uted work­force, 15-strong and grow­ing, head­quar­tered in Lawrence, Kansas.

And we have big plans for 2020 — new cov­er­age ar­eas, prod­ucts, and deep­er re­port­ing on the peo­ple and trends that shape the bio­phar­ma world. The best way to help us get there is up­grad­ing to In­sid­er or En­ter­prise.

If you de­pend on End­points, it’s a sure bet we de­pend on you too. So please join us now be­fore De­cem­ber 31 while our orig­i­nal In­sid­er and En­ter­prise rates re­main. You can al­ways con­tact our help­ful sup­port team at help@end­pointsnews.com or by vis­it­ing your Read­er Pro­file.

Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

Mene Pangalos via YouTube

As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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