Emer Cooke, EMA executive director (Martial Trazzini/Shutterstock)

Rare blood clot events more com­mon among women re­ceiv­ing As­traZeneca Covid-19 vac­cine, EMA says

The EMA is stick­ing with its state­ment that As­traZeneca’s Covid-19 vac­cine is safe and ef­fec­tive, but the agency al­so dis­cussed new da­ta show­ing that younger women are more fre­quent­ly see­ing these very rare cas­es of some­times fa­tal blood clots when com­pared with the gen­er­al pop­u­la­tion, al­though more women al­so re­ceived the vac­cine than men.

EMA ex­ec­u­tive di­rec­tor Emer Cooke said Wednes­day at a press con­fer­ence that the agency’s safe­ty com­mit­tee is still re­view­ing the rare events, known as cere­bral ve­nous si­nus throm­bo­sis (CVST), which as of March 22, to­tal 62 out of 9.2 mil­lion As­traZeneca vac­ci­na­tions across the Eu­ro­pean Eco­nom­ic Area (EEA). Four­teen of those 62 cas­es were fa­tal, and 44 oc­curred in the EEA, she not­ed.

The to­tal cas­es show that about 1 in 100,000 re­ceiv­ing the As­traZeneca vac­cine are see­ing these rare and se­vere events in Eu­rope, al­though a causal or as­so­cia­tive link be­tween the vac­cine and the events has not been es­tab­lished, ac­cord­ing to Pe­ter Ar­lett, head of the phar­ma­covig­i­lance and epi­demi­ol­o­gy de­part­ment at the EMA.

The num­ber of rare events for the As­traZeneca vac­cine al­so com­pares with less than 1 in 1 mil­lion for the Pfiz­er and Mod­er­na vac­cines each. But Cooke stressed that dif­fer­ent groups and num­bers of peo­ple have re­ceived each of the vac­cines so it’s dif­fi­cult to com­pare them.

The EMA’s safe­ty com­mit­tee, known as PRAC, will con­tin­ue to re­view the da­ta as it comes in on a dai­ly ba­sis and make an­oth­er an­nounce­ment on the As­traZeneca vac­cine next week, Cooke not­ed, ex­plain­ing that the EMA’s con­clu­sion two weeks ago has not changed and the ben­e­fits of the As­traZeneca vac­cine still out­weigh the risks.

But cas­es of CVST are oc­cur­ring at a high­er rate among those un­der the age of 60 and re­ceiv­ing the As­traZeneca vac­cine. Ar­lett added, “If we look at in­di­vid­u­als un­der 60, then we do see more cas­es of cere­bral ve­nous si­nus throm­bo­sis than we would ex­pect to see from the back­ground.”

Cooke al­so not­ed a high­er in­ci­dence among women be­tween the ages of 30 and 45, when com­pared to the gen­er­al pop­u­la­tion. CVST is more com­mon in women in gen­er­al, but about two-thirds of those re­ceiv­ing the As­traZeneca vac­cine in Eu­rope were women, Ar­lett added.

An As­traZeneca spokesper­son told End­points News via email: “While the EMA re­port­ed that the PRAC’s in­ves­ti­ga­tion did show some pre­dom­i­nance of cas­es in cer­tain groups in­clud­ing younger women they said it is pre­ma­ture to draw any con­clu­sions on that point right now. PRAC is cur­rent­ly as­sess­ing many pos­si­bil­i­ties in­clud­ing that the high­er pro­por­tion of cas­es seen in young women may be due to a high­er pro­por­tion of women vac­ci­nat­ed or a high­er risk of throm­bot­ic events in this pop­u­la­tion.”

The up­date from the EMA comes as Ger­many said it will stop us­ing As­traZeneca’s vac­cine on res­i­dents younger than 60. Sev­er­al jour­nal­ists ques­tioned the EMA on the to­tal of 62 CVST cas­es, not­ing that Ger­many alone has re­port­ed 31 cas­es, but Cooke said the 62 events do not ac­count for all of the Ger­man cas­es and the EMA’s safe­ty com­mit­tee will look at new­er fig­ures be­fore mak­ing its an­nounce­ment next week.

Cana­da al­so re­cent­ly said it would halt As­traZeneca shots for peo­ple 55 and younger, while Swe­den and Fin­land are on­ly us­ing the vac­cine for those over 65.

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

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, 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.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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Joe Biden (Carolyn Kaster, AP Images)

Covid-19 roundup: Biden in­vests $1.7B to ad­dress Covid vari­ants; EU puts faith in Pfiz­er with new vac­cine deals

The Biden administration said Friday that it’ll pump $1.7 billion into various programs to address Covid-19 variants as the original strain of Covid-19 makes up only about half of all US cases today.

Most of those new funds, $1 billion in total, will go to expand genomic sequencing so the CDC, states and other jurisdictions can improve their capacity to identify Covid mutations and monitor the circulation of variants. Back in February, US labs were only sequencing about 8,000 Covid-19 strains per week, although the rate of sequencing has increased substantially since then, the administration said.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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