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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

The slate of products we’re offering here at Endpoints is continuing to grow, and it’s not just limited to editorial. If you haven’t, do visit your reader profile to see if there are any other weekly newsletters you’re interested in — as each comes with its own exclusive content. And don’t miss the publisher’s note from Arsalan Arif on Endpoints Studio, our latest avenue for advertising on Endpoints.

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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