Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

Pres­i­dent Joe Biden’s ad­min­is­tra­tion on Mon­day re­vealed the dis­tri­b­u­tion list for 55 mil­lion of the 80 mil­lion dos­es of Covid-19 vac­cines Amer­i­ca plans to do­nate to low­er-in­come na­tions:

  • Rough­ly 14 mil­lion dos­es will head to Latin Amer­i­ca and the Caribbean, for a list of coun­tries that in­cludes Brazil, Ar­genti­na, Do­mini­can Re­pub­lic, Pana­ma and Cos­ta Ri­ca.
  • An­oth­er 16 mil­lion dos­es are head­ed to Asia to help the fol­low­ing coun­tries: In­dia, Nepal, Bangladesh, Pak­istan, Sri Lan­ka, Afghanistan, Mal­dives, Bhutan, Philip­pines, Viet­nam, In­done­sia, Thai­land, Malaysia, Laos, Papua New Guinea, Tai­wan, Cam­bo­dia, and the Pa­cif­ic Is­lands.

About 10 mil­lion dos­es are head­ed to Africa to share with a list of coun­tries that will be de­ter­mined by the African Union.

“Our goals are to in­crease glob­al Covid-19 vac­ci­na­tion cov­er­age, pre­pare for surges and pri­or­i­tize health­care work­ers and oth­er vul­ner­a­ble pop­u­la­tions based on pub­lic health da­ta and ac­knowl­edged best prac­tice, and help our neigh­bors and oth­er coun­tries in need,” the press re­lease said. “And, as we have pre­vi­ous­ly stat­ed, the Unit­ed States will not use its vac­cines to se­cure fa­vors from oth­er coun­tries.”

EU or­ders 150M more dos­es of Mod­er­na’s shot

An­oth­er 150 mil­lion dos­es of Mod­er­na’s vac­cine are head­ed to the EU, the com­mis­sion said Tues­day, af­ter it de­cid­ed to pick up an op­tion for more dos­es.

The an­nounce­ment comes af­ter Cure­Vac’s Covid-19 vac­cine flopped, with tri­al da­ta show­ing just 47% ef­fi­ca­cy and caus­ing ques­tions for coun­tries who al­ready inked deals with the Ger­man drug­mak­er.

The op­tion was a part of the EU’s strat­e­gy to build a stock of vac­cines for fu­ture use against vari­ants. The bloc said the de­ci­sion was not linked to the Cure­Vac an­nounce­ment, Reuters re­port­ed. The EU al­so signed a con­tract with Pfiz­er for 1.8 bil­lion dos­es of its vac­cine un­til 2023.

Mod­er­na’s ad­di­tion­al dos­es will be de­liv­ered next year and will help the 27-coun­try bloc pro­vide jabs for chil­dren and boost­ers.

2 new Eu­ro­pean sites ap­proved to make Pfiz­er/BioN­Tech vac­cine

Pfiz­er and BioN­Tech have gained ap­proval from the EMA for two more man­u­fac­tur­ing sites in Eu­rope, the agency an­nounced Tues­day.

A site in Rein­bek, Ger­many, is op­er­at­ed by Al­ler­gophar­ma GmbH, and an­oth­er in Stein, Switzer­land, op­er­at­ed by No­var­tis will car­ry out fill-fin­ish. The sites are now op­er­a­tional im­me­di­ate­ly, as they do not re­quire any de­ci­sion from the Eu­ro­pean Com­mis­sion.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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Covid-19 roundup: Re­gen­eron's mAB gets ex­pand­ed EUA; mR­NA drug­mak­ers spike price of vac­cines in EU sup­ply deal

The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.

The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who are at high risk of exposure “in an institutional setting” like a nursing home or a prison, and are not fully vaccinated or expected to provide a sufficient immune response.

Regeneron experts predict that 3% of the US population may not be able to fully respond to Covid-19 vaccinations.

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.