Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.