A vol­un­teer in As­traZeneca’s Covid-19 vac­cine tri­al in Brazil has died, Brazil­ian health au­thor­i­ties said Wednes­day, trig­ger­ing fresh alarms over the fu­ture of the Ox­ford pro­gram. But lat­er re­ports not­ed that the death was in the place­bo group and As­traZeneca is­sued word that there were no con­cerns about con­tin­u­ing the study.

The Brazil­ian health agency An­visa said it had re­ceived da­ta from an in­ves­ti­ga­tion in­to the is­sue, per a Reuters re­port. The re­port was then up­dat­ed cit­ing a source fa­mil­iar with the mat­ter say­ing that the tri­al would have been sus­pend­ed had the vol­un­teer been giv­en the ex­per­i­men­tal Covid-19 vac­cine, im­ply­ing that they were part of the place­bo arm.

Ox­ford Uni­ver­si­ty, which is de­vel­op­ing the vac­cine in tan­dem with As­traZeneca, told Reuters that af­ter as­sess­ing the sit­u­a­tion, “there have been no con­cerns about safe­ty of the clin­i­cal tri­al.” An­visa added that the vac­cine tri­als will con­tin­ue in the wake of the death. The agency gave no fur­ther de­tails in­to the cir­cum­stances.

As­traZeneca $AZN share prices dipped about 2% as the news broke, but since lev­eled off and closed Wednes­day down 1.19%.

A com­pa­ny spokesper­son gave the fol­low­ing com­ment to End­points News:

We can­not com­ment on in­di­vid­ual cas­es in an on­go­ing tri­al of the Ox­ford vac­cine as we ad­here strict­ly to med­ical con­fi­den­tial­i­ty and clin­i­cal tri­al reg­u­la­tions, but we can con­firm that all re­quired re­view process­es have been fol­lowed. All sig­nif­i­cant med­ical events are care­ful­ly as­sessed by tri­al in­ves­ti­ga­tors, an in­de­pen­dent safe­ty mon­i­tor­ing com­mit­tee and the reg­u­la­to­ry au­thor­i­ties. These as­sess­ments have not led to any con­cerns about con­tin­u­a­tion of the on­go­ing study.

Re­ports ear­li­er Wednes­day not­ed that As­traZeneca was sched­uled to restart its Phase III study in the US some­time this week. Dos­ing came to a halt world­wide in ear­ly Sep­tem­ber af­ter a British vol­un­teer de­vel­oped a con­di­tion thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der.

Tri­als have al­ready re­sumed in the UK, In­dia, Japan and South Africa in ad­di­tion to Brazil, and the EMA has since ini­ti­at­ed a rolling re­view of the vac­cine can­di­date.

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

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

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But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

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Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.