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.

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.

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.

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.