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

Covid-19 roundup: Eu­ro­pean Com­mis­sion's le­gal bat­tle against As­traZeneca be­gins; Kaza­khstan gives green light to do­mes­tic vac­cine

The Eu­ro­pean Com­mis­sion’s le­gal case against As­traZeneca for fail­ing to de­liv­er the amount of vac­cine dos­es laid out in a con­tract be­gan in a Brus­sels court on Wednes­day, ac­cord­ing to Reuters. 

The EC re­quest­ed im­me­di­ate de­liv­er­ies from all fac­to­ries list­ed in the con­tract, in­clud­ing ones in Britain, the news agency re­port­ed. It’s been two days since the EC an­nounced it would take le­gal ac­tion.

The dis­pute be­gan back in Jan­u­ary, when As­traZeneca in­formed the EU that it wouldn’t be able to de­liv­er the promised num­ber of dos­es laid out in a sup­ply con­tract due to pro­duc­tion lags. The con­tract al­lowed for the pur­chase of 300 mil­lion dos­es, with an op­tion for 100 mil­lion more. But on­ly 30 mil­lion were de­liv­ered in Q1 2021, and As­traZeneca promised 70 mil­lion in Q2, as op­posed to the 180 mil­lion that had been promised.

The EU pub­lished a heav­i­ly redact­ed ver­sion of the con­tract in an ef­fort to fos­ter trans­paren­cy. But af­ter in­ter­net sleuths and Ger­man jour­nal­ists found the blacked-out sec­tions could be eas­i­ly re­moved, the EU pub­licly apol­o­gized.

CEO Pas­cal So­ri­ot has as­sert­ed the con­tracts are not legal­ly bind­ing due to a “best ef­fort” clause in the text.

As­traZeneca said in a state­ment Mon­day that al­most 50 mil­lion dos­es are com­ing by the end of April, which it said is “in line with our fore­cast.”

“As­traZeneca deeply re­grets the de­ci­sion of the Eu­ro­pean Com­mis­sion to start this le­gal ac­tion in re­la­tion with the COVID-19 sup­ply agree­ment. We hope to re­solve this dis­pute as soon as pos­si­ble,” com­pa­ny lawyer Hakim Boular­bah said in court, per Reuters.

Two more hear­ings are sched­uled on May 26, and a judge is ex­pect­ed to de­cide on the case in June, Reuters re­port­ed.

Kaza­khstan gives green light to vac­cine be­fore it com­pletes test­ing

Kaza­khstan is rolling out its own Covid-19 shot, dubbed Qaz­Vac, be­fore it has com­plet­ed Phase III test­ing.

“The first batch of Qaz­Vac vac­cine ar­rived in the re­gions of the coun­try,” pres­i­dent Kassym-Jo­mart Tokayev tweet­ed on April 23. “Vac­cine pro­duc­tion will be in­creased to make it avail­able to all cit­i­zens.”

The vac­cine, de­vel­oped by the Re­search In­sti­tute for Bi­o­log­i­cal Safe­ty Prob­lems, en­tered a Phase I/II tri­al in Kaza­khstan back in Sep­tem­ber. Sci­en­tist Lep­ek Ku­tum­be­tov re­port­ed­ly test­ed it on him­self, then told the state-owned me­dia or­ga­ni­za­tion Kaz­in­form it is “harm­less.”

Since then, the re­search in­sti­tute has said that all 222 par­tic­i­pants in the first two stages of test­ing have de­vel­oped im­mu­ni­ty, with no ma­jor side ef­fects, ac­cord­ing to Reuters. A 3,000-per­son Phase III tri­al is ex­pect­ed to wrap up in Ju­ly.

Near­ly a mil­lion cit­i­zens have al­ready been vac­ci­nat­ed with Rus­sia’s Sput­nik V, and the coun­try has or­dered a mil­lion dos­es of Chi­na’s Sinopharm vac­cine, Reuters re­port­ed.

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

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

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Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Distribution of Moderna's Covid-19 Vaccine (Photo by Paul Sancya - Pool/Getty Images)

Opin­ion: Ado­les­cents can wait. The US needs to start do­nat­ing Covid-19 vac­cines to needy coun­tries now.

Now that the US is swimming in Covid-19 vaccines and the supply has officially eclipsed the demand, it’s time for America to lead the world and start shipping these excess doses to countries that desperately need them.

Unlike the IP waiver at the World Trade Organization, which Biden now supports and will likely take years to translate into actual shots in arms, the US could easily donate just a tiny fraction of the more than 60 million doses of Pfizer, Moderna and J&J vaccines sitting on American shelves right now.