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.

Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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FDA ex­pert pan­el unan­i­mous­ly rec­om­mends ap­proval for Hori­zon Ther­a­peu­tics eye drug

An FDA advisory committee noted with concern a small safety database but unanimously endorsed a Horizon Therapeutics drug for a rare eye autoimmune disease that can blind patients: teprotumumab for thyroid eye disease (TED).

“It was a pretty easy vote,” said Erica Brittain, an NIH biostatistician and one of the 12 panelists on FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee.

This image shows a lab technician measuring the zone of inhibition during an antibiotic sensitivity test, 1972. The zone of inhibition is measured and compared to a standard in order to determine if an antibiotic is effective in treating the bacterial infection. (Gilda Jones/CDC via Getty Images)

Bio­phar­ma has aban­doned an­tibi­ot­ic de­vel­op­ment. Here’s why we did, too.

Timing is Everything
When we launched Octagon Therapeutics in late 2017, I was convinced that the time was right for a new antibiotic discovery venture. The company was founded on impressive academic pedigree and the management team had known each other for years. Our first program was based on a compelling approach to targeting central metabolism in the most dangerous bacterial pathogens. We had already shown a high level of efficacy in animal infection models and knew our drug was safe in humans.

Shehnaaz Suli­man dives back in­to Alzheimer's at Alec­tor; Pyx­is re­cruits Spring­Works founder Lara Sul­li­van as CEO

Amid Shehnaaz Suliman’s lengthy resume it could be easy to miss her stint leading early-stage Alzheimer’s R&D at Genentech, where she oversaw a program for the ill-fated crenezumab and initiated one of the first prevention studies around the devastating neurodegenerative disease. But it is this experience that she — after thinking long and hard about her next career move over the past months — will be leaning heavily on as the first president and COO of Alector.

PhII fail­ure in rare neu­rode­gen­er­a­tive dis­ease? No mat­ter, Bio­gen will mo­tor on in Alzheimer's

Biogen’s fierce focus on disorders of the brain has hit another roadblock.

On Friday, the US drugmaker — which recently resurrected its amyloid-targeting Alzheimer’s drug, aducanumab — said its anti-tau drug, gosuranemab, failed a mid-stage study in patients with progressive supranuclear palsy (PSP), a rare brain disorder that results from deterioration of brain cells that control movement and thought.