Pascal Soriot, AstraZeneca CEO (Photo by Chris Jackson/Getty Images)

Pas­cal So­ri­ot would­n't 'do any­thing dif­fer­ent­ly' in Covid-19 vac­cine de­vel­op­ment — re­port

While Mod­er­na and Pfiz­er have tak­en much of the lime­light when it comes to Covid-19 vac­cines, As­traZeneca’s boss is stand­ing by his com­pa­ny’s de­vel­op­ment ef­forts.

In an in­ter­view with the BBC on Mon­day, As­traZeneca CEO Pas­cal So­ri­ot claimed the com­pa­ny’s Covid-19 vac­cine has man­aged to save a mil­lion lives de­spite fac­ing set­backs. So­ri­ot ad­dressed stud­ies link­ing the vac­cine to rare blood clots, but in look­ing back on the vac­cine’s de­vel­op­ment, he told BBC: “I don’t think I would do any­thing dif­fer­ent­ly from what we did.

In 2021, the EMA found rare but dan­ger­ous blood clots linked to the vac­cine, but Eu­ro­pean of­fi­cials still tout­ed its safe­ty and ef­fi­ca­cy. The shot was nonethe­less rolled out across the globe and So­ri­ot re­ceived a knight­hood dur­ing the Queen’s Ju­bilee cel­e­bra­tion last week.

So­ri­ot did ac­knowl­edge that the ini­tial roll­out of the vac­cine did come with set­backs, BBC’s re­port said.

“We de­cid­ed to do it at no prof­it, we de­cid­ed to part­ner with a net­work of part­ners around the world to scale up man­u­fac­tur­ing. De­spite the set­backs, we de­liv­ered three bil­lion dos­es [of the vac­cine] and saved a mil­lion lives,” he told BBC. “When you launch your­self in some­thing like this, which is a huge un­der­tak­ing, you have to ac­cept that you will have set­backs.”

It is no se­cret that the As­traZeneca vac­cine has had a tough time get­ting off the ground in the US. In 2021, As­traZeneca’s top re­searcher Mene Pan­ga­los sig­naled that the com­pa­ny may cut away from sub­mit­ting its Covid-19 vac­cine to the US FDA for ap­proval. The com­pa­ny has had to com­pete with Mod­er­na and Pfiz­er, who have been rul­ing the roost in terms of get­ting jabs in­to arms, and the US has do­nat­ed mil­lions of As­traZeneca’s vac­cines to oth­er na­tions.

And in April of this year, the com­pa­ny saw its vac­cine sales be­gin to di­min­ish as the pan­dem­ic is en­ter­ing a dif­fer­ent phase where an­tivi­rals are be­com­ing more of a main­stay.

So­ri­ot claimed to an­a­lysts at the time that there is an over­abun­dance of sup­ply and still sticks to that line to­day, but with the pan­dem­ic en­ter­ing a new phase, the CEO wants As­traZeneca to switch gears as well. In May, the com­pa­ny part­nered with Van­der­bilt Uni­ver­si­ty re­searchers to de­vel­op the long-act­ing an­ti­body com­bo now known as Evusheld and ob­tained world­wide li­cens­es to a suite of ear­ly-stage an­ti­bod­ies tar­get­ing SARS-CoV-2 from up­start RQ Biotech­nol­o­gy in a $157 mil­lion deal.

While So­ri­ot still touts his vac­cine and the side ef­fects as be­ing ex­treme­ly rare, some shots have been on the shelf so long they are be­ing de­stroyed. As­traZeneca, like its ri­vals, is al­so deal­ing with vac­cine hes­i­tan­cy in some na­tions, with in­di­vid­u­als in de­vel­op­ing coun­tries re­fus­ing to take the shots.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Up­dat­ing the Covid-19 vac­cine: FDA of­fers a qual­i­fied thumbs-up ahead of ad­comm

The FDA’s adcomm of outside vaccine experts will meet tomorrow to discuss how to protect the US from a likely coming wave of Omicron cases in the fall and winter, and whether to deploy vaccines that specifically target the Omicron variant.

While the data so far are limited, the FDA sounded an upbeat tone in the briefing documents on Pfizer/BioNTech’s candidates, released this weekend ahead of the VRBPAC meeting.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.