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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; 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.

Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.