End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

End­points News turned five years old over the week­end. I want­ed to mark the hap­py oc­ca­sion by ex­tend­ing our deep­est grat­i­tude to End­points’ pre­mi­um sub­scribers while out­lin­ing sev­er­al oth­er ways to sup­port us as we go broad­er and get big­ger this year and be­yond.

Same as any busi­ness, we’ve got to cre­ate val­ue and get paid for de­liv­er­ing it. So if you de­pend on End­points to stay abreast on bio­phar­ma de­vel­op­ments, we de­pend on you too.

The best way to sup­port us is by up­grad­ing to a pre­mi­um sub­scrip­tion. It’s our most im­por­tant source of rev­enue be­cause it ties our ed­i­to­r­i­al in­cen­tives di­rect­ly to read­er ex­pec­ta­tions — fo­cus­ing on qual­i­ty over quan­ti­ty. We work to de­liv­er some­thing worth pay­ing for every day. Not just an­oth­er email clog­ging your in­box.

We have two plans: In­sid­er for in­di­vid­u­als ($225/year) and En­ter­prise for com­pa­nies ($1,000/year). Both of them un­lock the com­plete End­points ex­pe­ri­ence and con­tent li­brary. The En­ter­prise plan is a flat rate that cov­ers all em­ploy­ees, and you don’t need to ne­go­ti­ate rates with us or pick who on your team gets ac­cess. Every­one does. Check out our en­tire pre­mi­um cat­a­log here.

And if you have ques­tions, our cus­tomer ser­vice team is quick to re­spond — you can chat with them here.

This year we launched three new ti­tles. End­points FDA+ and End­points Man­u­fac­tur­ing — spear­head­ed by se­nior ed­i­tor Zachary Bren­nan and man­ag­ing ed­i­tor Kyle Blanken­ship, re­spec­tive­ly — is your one-stop look at the most crit­i­cal de­vel­op­ments in those fields and what they mean for bio­phar­ma. And se­nior ed­i­tor Am­ber Tong is be­hind our new End­points Week­ly, which re­caps the busy week in bio­phar­ma every Sat­ur­day morn­ing. You can add these ti­tles to your sub­scrip­tion by vis­it­ing your Read­er Pro­file, or if you’re new to End­points, via our sign-up page.

If a pre­mi­um sub­scrip­tion isn’t in the cards yet, but you’d still like to sup­port us, please help spread the word and share End­points with your col­lab­o­ra­tors. Noth­ing is bet­ter than re­fer­rals, and it’s where we get most of our new sub­scribers. Just share our URLs and for­ward our email re­ports to your col­leagues. Most End­points cov­er­age is free to read, with no pay­ment re­quired for a ba­sic sub­scrip­tion.

We’ve al­so spent the past five years op­ti­miz­ing our ad­ver­tis­ing prod­ucts. So for mar­ket­ing lead­ers who need to reach ei­ther a large or tar­get­ed au­di­ence in the life sci­ences, we’d love to talk.

End­points is dif­fer­ent in that we in­ten­tion­al­ly keep ad­ver­tis­ing space tight. That helps pop the brand ad­ver­tis­ing cam­paigns on our site. It re­duces spon­sor­ship fa­tigue from the read­ers and in­creas­es con­ver­sions. Our chief rev­enue of­fi­cer Mike Peck has built a sales team where re­la­tion­ships mat­ter most. We’re in­ter­est­ed in get­ting more from clients who see ex­cel­lent re­sults with us, not milk­ing every deal for pen­nies. And End­points’ cus­tomer ser­vice, led by our tal­ent­ed COO Shelly Whit­field, is sec­ond-to-none. Her team works to ex­e­cute cam­paigns for 200+ ad­ver­tis­ing clients, and they do great work.

Af­ter five years in busi­ness, we’ve grown to 32 full-time em­ploy­ees with more on the way. 100,000+ in­dus­try pros get our news di­rect­ly in their in­box dai­ly. Dur­ing the pan­dem­ic, our vir­tu­al events at­tract­ed 32,000 at­ten­dees. And yet, End­points’ mis­sion hasn’t changed since day one: In­form and con­nect the bio­phar­ma world with re­lent­less dai­ly re­port­ing.

To all of our cur­rent pre­mi­um sub­scribers who’ve di­rect­ly fund­ed our growth: Thank you. Get­ting to this mile­stone was im­pos­si­ble with­out your sup­port. To every­one who is con­sid­er­ing get­ting one to­day for them­selves or their com­pa­ny: We’ll work hard to con­tin­ue earn­ing your sup­port every day.

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; 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.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.

Alan Hirzel, Abcam

Drug sup­pli­er Ab­cam brings a long­time col­lab­o­ra­tor in house as part of $340M buy­out pact

BioVision has supplied Abcam with research tools since 1999, and now the two are making it official as part of a merger unveiled Monday.

Abcam will buyout BioVision as part of a $340 million acquisition deal to bring aboard the supplier’s biochemical and cell-based assays for biological research, as well as recombinant proteins, antibodies and enzymes.

The deal will give Abcam control of BioVision’s portfolio and allow for both the expansion of research existing areas of focus such as oncology, neuroscience and epigenetics and preparation to expand into new products. As a part of the deal, Abcam will develop and supply products and services to NKY, the previous owner of BioVision and receive support for ongoing development and commercialization of in vitro diagnostic products.