Covid-19 man­u­fac­tur­ing roundup: FDA frees up more Emer­gent vac­cine dos­es; Pfiz­er and Viet­nam dis­cuss tech trans­fer — re­port

The FDA has freed up yet an­oth­er batch of J&J Covid-19 vac­cines that were held up due to con­t­a­m­i­na­tion at Emer­gent’s Bal­ti­more Bayview plant.

In a let­ter ad­dressed to J&J’s North Amer­i­can Reg­u­la­to­ry leader Ru­ta Walawalkar, the agency re-is­sued emer­gency use au­tho­riza­tion to one more batch on Ju­ly 13. That will free up an­oth­er 10 mil­lion dos­es Bloomberg re­ports.

“I am waiv­ing Cur­rent Good Man­u­fac­tur­ing Prac­tice re­quire­ments for this batch, and on­ly this batch, for the du­ra­tion of this EUA,” the let­ter, signed by di­rec­tor of vac­cines and re­search Mar­i­on Gru­ber, says. “This con­cur­rence does not add any oth­er batch­es man­u­fac­tured at this fa­cil­i­ty to the EUA at this time and does not add the fa­cil­i­ty it­self to the EUA at this time, nor does the EUA cov­er vac­cine man­u­fac­tured by com­bin­ing this batch with dif­fer­ent batch­es of drug sub­stance that are not au­tho­rized ex­plic­it­ly un­der this EUA.”

That marks the fifth batch of drug sub­stance that has been freed up af­ter a mishap that led to 75 mil­lion to­tal dos­es be­ing de­stroyed and tens of mil­lions more held back for test­ing. This brings the num­ber of J&J batch­es re­leased to about 50 mil­lion.

A batch of the vac­cine dos­es cleared last week had not yet been bot­tled, The New York Times re­port­ed, and US Pres­i­dent Joe Biden’s ad­min­is­tra­tion has not yet re­vealed what it will do with the dos­es. They could be head­ed else­where, as the US has just pledged 1 mil­lion dos­es of J&J’s jab to Bo­livia by Thurs­day, ac­cord­ing to CNN.

Pfiz­er and Viet­nam dis­cuss tech trans­fer: re­port

As Viet­nam sees a record num­ber of new Covid-19 in­fec­tions, the coun­try’s gov­ern­ment says it’s in talks with Pfiz­er about the pos­si­bil­i­ty of a tech­nol­o­gy trans­fer or open­ing a Pfiz­er plant, Reuters re­port­ed Wednes­day.

In June, the coun­try’s health min­istry said a lo­cal com­pa­ny was lined up to man­u­fac­ture the jab af­ter a trans­fer deal was ne­go­ti­at­ed with “an uniden­ti­fied US part­ner.” It did hint that the vac­cine would be mR­NA based and Pfiz­er’s vac­cine is ap­proved for use in the coun­try, along with Chi­na’s Sinopharm and As­traZeneca’s jab.

The coun­try had suc­cess­ful­ly staved off the virus for much of the pan­dem­ic, but since April, has bat­tled a stub­born out­break, which has ap­plied pres­sure on its gov­ern­ment to ramp up its vac­cine in­oc­u­la­tion. Few­er than 300,000 peo­ple in the coun­try have got­ten the shot, Reuters said.

Over 90% of the coun­try’s cas­es have been re­port­ed since May.

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.