Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Sev­er­al coun­tries had restart­ed their por­tions of As­traZeneca’s glob­al Phase III Covid-19 vac­cine tri­al af­ter the study was paused world­wide in ear­ly Sep­tem­ber, but the US no­tably stayed on the side­lines — un­til now. Fri­day af­ter­noon the phar­ma gi­ant an­nounced the all clear from US reg­u­la­tors. And on top of that, J&J an­nounced Fri­day evening that it’s prepar­ing to re­sume its own Phase III vac­cine tri­al.

The FDA gave As­traZeneca the go-ahead to con­tin­ue the tri­al state­side af­ter con­clud­ing that it would be safe to press ahead, ac­cord­ing to a com­pa­ny state­ment sent to End­points News. The green light comes rough­ly a month-and-a-half af­ter the study had been vol­un­tar­i­ly stopped. Reg­u­la­tors had been in­ves­ti­gat­ing two cas­es of a pos­si­ble neu­ro­log­i­cal side ef­fect in the ex­per­i­men­tal vac­cine, but ap­pear sat­is­fied with their find­ings.

The news on the As­traZeneca tri­al was first re­port­ed by the Wall Street Jour­nal. The FDA did not find the vac­cine was re­spon­si­ble for the side ef­fects, ac­cord­ing to the Jour­nal, but could not rule out a link, ei­ther. Lat­er on Fri­day, J&J an­nounced that the in­de­pen­dent DSMB had rec­om­mend­ed re­sum­ing tri­al re­cruit­ment and fol­low­ing dis­cus­sions with the FDA, J&J is now prepar­ing to pro­ceed.

“The restart of clin­i­cal tri­als across the world is great news as it al­lows us to con­tin­ue our ef­forts to de­vel­op this vac­cine to help de­feat this ter­ri­ble pan­dem­ic,” As­traZeneca CEO Pas­cal So­ri­ot said in their state­ment. “We should be re­as­sured by the care tak­en by in­de­pen­dent reg­u­la­tors to pro­tect the pub­lic and en­sure the vac­cine is safe be­fore it is ap­proved for use.”

Go­ing for­ward, re­searchers and clin­i­cians at As­traZeneca tri­al sites will be re­quired to in­form vol­un­teers of the cas­es and look out for any po­ten­tial neu­ro­log­i­cal events, such as numb­ness.

As­traZeneca’s vac­cine had been on pace to re­ceive au­tho­riza­tion for emer­gency use be­fore the end of year pri­or to the tri­al’s halt in Sep­tem­ber. The com­pa­ny re­mains 3rd in End­points News’ Covid-19 vac­cine race track­er, be­hind on­ly Pfiz­er and Mod­er­na. With the US tri­al able to get back up and run­ning, As­traZeneca says it’s an­tic­i­pat­ing to have the re­sults of the study lat­er this year, de­pend­ing on the rate of in­fec­tion in the tri­al sites’ com­mu­ni­ties.

The two cas­es stud­ied by the agency in­clude an in­stance in Ju­ly when a pa­tient de­vel­oped what was thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der, but turned out to be mul­ti­ple scle­ro­sis un­re­lat­ed to the vac­cine. Then in Sep­tem­ber, an­oth­er neu­ro­log­i­cal event in a British pa­tient al­so be­lieved to be trans­verse myelitis caused the glob­al tri­al halt.

Tri­als had al­ready re­sumed in the UK, home of As­traZeneca’s head­quar­ters, as well as Brazil, Japan, South Africa and In­dia. The EMA ini­ti­at­ed a rolling re­view of the vac­cine at the start of Oc­to­ber.

J&J had or­dered a pause to its late-stage Covid-19 vac­cine tri­als on Oct. 12 af­ter an in­ci­dent of a stroke, ac­cord­ing to an ear­li­er Wash­ing­ton Post re­port, though the ill­ness was orig­i­nal­ly undis­closed. J&J said that there was no clear cause of the event and no ev­i­dence it was a re­sult of its vac­cine.

The com­pa­ny al­so not­ed it will not say whether or not that par­tic­i­pant re­ceived an ex­per­i­men­tal vac­cine dose or place­bo in or­der to main­tain the dou­ble-blind­ed­ness of the study.

Like As­traZeneca, J&J is re­search­ing an ade­n­ovirus vac­cine, though the lat­ter’s vac­cine on­ly re­quires a sin­gle dose. J&J is plan­ning on re­cruit­ing 60,000 pa­tients.

Reuters had pre­vi­ous­ly re­port­ed that the As­traZeneca tri­al could re­sume this week, and Warp Speed chief Mon­cef Slaoui had told Bloomberg that he ex­pect­ed both to restart be­fore the end of the week.

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

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Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

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Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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FDA re­view­ers en­dorse J&J sin­gle-dose shot, lay­ing path for 3rd US vac­cine

J&J’s single-dose vaccine may not have produced quite the stellar numbers of the mRNA shots, but it still won a ringing endorsement from FDA reviewers, who argued in briefing documents that it could provide robust protection against the still-raging virus.

The FDA confirmed that across just under 40,000 volunteers, the vaccine proved 66% effective at preventing symptomatic Covid-19, including 72% effective in the United States. Although that’s short of the 95% figures put up by Moderna and Pfizer-BioNTech, the shot was still 85% effective at stopping severe disease 28 days after administration. There were seven deaths in the placebo group — zero in the vaccine group.

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