That feel­ing you get when you hit the fin­ish line, and then set new goals


Self-con­grat­u­la­tion is an art form most of us mas­ter at an ear­ly age. And I’m no dif­fer­ent from your av­er­age per­son.

Like every­one, I un­der­stand noth­ing is sweet­er than the last step of a 1,000-mile march to the fin­ish line of a big goal. We as­sume that every­one wants to cel­e­brate with us when we ar­rive, but that’s not usu­al­ly the case.

So I’ll keep this short and sweet.

Some­time in the next day or so, End­points News will pass the 50,000 mark on sub­scribers. That is the sec­ond of two goals I set out for my­self at the be­gin­ning — June 20, 2016. The ‘win’ I was look­ing for (along­side 500,000-plus web traf­fic and 250,000-plus month­ly users, a goal we blew the doors off of months ago). And I’ve de­vot­ed a good deal to achiev­ing it.

For me, every­one work­ing in bio­phar­ma R&D is a res­i­dent of a glob­al city. They are part of an or­gan­ic whole, whether they live in Shang­hai, South San Fran­cis­co or ei­ther Cam­bridge. And they can be con­nect­ed in­stant­ly. That’s what we do. We con­nect. We’re the news cir­cuit this net­work plugs in­to, pow­ered by an ever-evolv­ing set of events that re­veals un­der­ly­ing trends.

Now, if you’re as­sum­ing that we blast out to some spam group as­so­ci­at­ed with bio­phar­ma, put that aside. Each and every in­di­vid­ual who sub­scribed in the US, the UK, Chi­na, Switzer­land, or Den­mark or Cana­da, etc. asked for it per­son­al­ly. I know. I have an app on my phone that lets me see the score in re­al time. And every­one can leave at a mo­ment’s no­tice. I check it, um, reg­u­lar­ly.

You mea­sure a long jour­ney in small amounts of progress. You want to win a ball game? Win every in­ning and the last out is a breeze. And I’m two years, 10 months and 20 days in­to this ball game. When I found­ed this boot-strap ven­ture, I was clos­ing in on 60. So I al­so have the rare plea­sure of start­ing out on a mis­sion that can ob­jec­tive­ly be de­fined as clin­i­cal­ly in­sane.

Ini­tial­ly, this busi­ness was just Ar­salan Arif, Shehla Shakoor with some big help from Ig­or Yavych, and me. So you could say it in­volved a lot of work for all of us. We’ve grown, adding great writ­ers and ed­i­tors, con­trib­u­tors, de­sign­ers, and sales/ops peo­ple to the mix. Me­dia is by de­f­i­n­i­tion a team sport. And there was no get­ting to this point alone. Ever.

Achiev­ing one goal is an ex­cel­lent rea­son to set out new ones. 100,000 sub­scribers-plus with a mil­lion-plus in month­ly web traf­fic and 500,000 users lie out there — and maybe not so far out. A much big­ger team will make that hap­pen. And I’ll stay a play­er/coach for some time if the jour­nal­ism gods are kind.

Thank you for read­ing, and thanks for pass­ing us along to your col­leagues, which is our on­ly mar­ket­ing strat­e­gy. For those of you who paid for the pre­mi­um sub­scrip­tion, I’d like to of­fer spe­cial thanks. With­out all of you, this would be me shout­ing down a well on the In­ter­net. I don’t much care for lone­ly pur­suits.

So raise a glass, say cheers and let’s move on to the next goal.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.