Covid-19 roundup: Eu­ro­pean Com­mis­sion sues As­traZeneca over vac­cine sup­plies; South Africa re­sumes J&J vac­cine tri­al

The Eu­ro­pean Com­mis­sion said Mon­day that it’s tak­ing le­gal ac­tion against As­traZeneca for fail­ing to pro­vide a suf­fi­cient num­ber of vac­cine dos­es as out­lined in its con­tract.

As­traZeneca’s con­tract with the EU al­lowed for the pur­chase of 300 mil­lion dos­es, with an op­tion for 100 mil­lion more. But on­ly 30 mil­lion dos­es were de­liv­ered in the first quar­ter of 2021, ac­cord­ing to the AP, and the com­pa­ny says it can pro­vide 70 mil­lion in the sec­ond quar­ter, rather than the 180 mil­lion it had promised.

As­traZeneca said in a state­ment Mon­day that it is about to de­liv­er al­most 50 mil­lion dos­es to the EU by the end of April, “in line with our fore­cast. As­traZeneca has ful­ly com­plied with the Ad­vance Pur­chase Agree­ment with the Eu­ro­pean Com­mis­sion and will strong­ly de­fend it­self in court. We be­lieve any lit­i­ga­tion is with­out mer­it and we wel­come this op­por­tu­ni­ty to re­solve this dis­pute as soon as pos­si­ble.” — Zachary Bren­nan

South Africa re­sumes J&J vac­cine tri­al

As the US lifts its pause on the roll­out of John­son & John­son’s Covid-19 vac­cine, South Africa is al­so re­sum­ing a study that had been paused over con­cerns of rare blood clots, ac­cord­ing to Reuters

“It is much bet­ter to have the vac­cine than to avoid tak­ing it for fear of get­ting a blood clot,” Health Min­is­ter Zweli Mkhize said, per the out­let.

A con­cern­ing vari­ant emerged in South Africa months ago, which now has the high­est Covid-19 case count on the con­ti­nent. Ear­li­er this month, of­fi­cials halt­ed the roll­out of As­traZeneca and Ox­ford Uni­ver­si­ty’s vac­cine af­ter a study showed it didn’t pro­tect against mild-to-mod­er­ate cas­es caused by the B.1.351 vari­ant, which is now wide­spread in South Africa. The coun­try has since sold its re­main­ing dos­es of the jab to the African Union, Reuters re­port­ed.

Just less than two weeks ago, the US slammed the brakes on roll­out of J&J’s jab over con­cerns about rare but some­times fa­tal blood clots in women be­tween the ages of 18 and 49. But the FDA and CDC de­cid­ed on Fri­day that the vac­cine’s known and po­ten­tial ben­e­fits still out­weigh the risks.

The FDA has up­dat­ed the fact sheets for vac­cine re­cip­i­ents and providers to note the risk of blood clots and low lev­els of platelets, known as throm­bo­sis with throm­bo­cy­tope­nia syn­drome (TTS). The CDC said it has record­ed 15 cas­es of TTS, among about 8 mil­lion re­ceiv­ing the vac­cine. Among those cas­es are three deaths, sev­en peo­ple hos­pi­tal­ized, four of whom are in in­ten­sive care, and five peo­ple dis­charged.

South African au­thor­i­ties promised “in­ten­si­fied pre-vac­ci­na­tion as­sess­ment and post-vac­ci­na­tion mon­i­tor­ing” ac­cord­ing to Reuters. So far, 290,000 health­care work­ers have re­ceived the shot as part of the study, which seeks to en­roll 500,000 peo­ple, the news agency said. — Nicole De­Feud­is

Biden ad­min­is­tra­tion al­lows ex­port of raw vac­cine ma­te­ri­als to In­dia 

In an ef­fort to help In­dia through what’s shap­ing up to be the world’s worst Covid-19 surge yet, the Biden ad­min­is­tra­tion said it would par­tial­ly lift an em­bar­go on raw vac­cine ma­te­ri­als and send vi­tal sup­plies like test kits, ther­a­peu­tics and ven­ti­la­tors to the strug­gling coun­try.

In­dia has long held the world’s sec­ond-high­est Covid-19 case count, be­hind on­ly the US. How­ev­er, the coun­try re­port­ed 2,767 deaths in the last 24 hours, as op­posed to 868 in the US.

On Thurs­day, the coun­try record­ed 314,000 new in­fec­tions — the world’s high­est ever sin­gle-day jump, ac­cord­ing to the Wall Street Jour­nal. And cas­es have on­ly gone up since.

Emi­ly Horne, a spokes­woman for the Na­tion­al Se­cu­ri­ty Coun­cil, said in a state­ment that the US has iden­ti­fied sources of raw ma­te­r­i­al to be used for the man­u­fac­tur­ing of Co­v­ishield, In­dia’s ver­sion of the As­traZeneca/Ox­ford vac­cine. It has promised to send ther­a­peu­tics, rapid di­ag­nos­tic test kits, ven­ti­la­tors and per­son­al pro­tec­tive equip­ment, and fund an ex­pan­sion at vac­cine man­u­fac­tur­er BioE that would en­able it to pro­duce at least a bil­lion dos­es by the end of 2022. Plus, the ad­min­is­tra­tion is send­ing a team of pub­lic health ad­vi­sors from the CDC.

“Just as In­dia sent as­sis­tance to the Unit­ed States as our hos­pi­tals were strained ear­ly in the pan­dem­ic, the Unit­ed States is de­ter­mined to help In­dia in its time of need,” Horne said in the email state­ment.

Un­til now, the Biden ad­min­is­tra­tion has avoid­ed lift­ing an em­bar­go on raw vac­cine ma­te­ri­als, ac­cord­ing to the New York Times. Just last week, State De­part­ment spokesman Ned Price told re­porters the coun­try is “first and fore­most is en­gaged in an am­bi­tious and ef­fec­tive and, so far, suc­cess­ful ef­fort to vac­ci­nate the Amer­i­can peo­ple.”

De­spite lift­ing the em­bar­go, the ad­min­is­tra­tion has blocked re­quests made by In­dia and South Africa for a tem­po­rary waiv­er to an in­tel­lec­tu­al prop­er­ty agree­ment that would pave the way for gener­ic ver­sions of vac­cines and treat­ments, the Times re­port­ed. — Nicole De­Feud­is

South Ko­rea pres­i­dent to meet with No­vavax about ac­cel­er­at­ed ap­proval of vac­cine — re­port

South Ko­rea pres­i­dent Moon Jae-in is re­port­ed­ly in talks with No­vavax CEO Stan­ley Er­ck about ex­pand­ing pro­duc­tion of the drug­mak­er’s Covid-19 vac­cine — and po­ten­tial­ly ap­prov­ing it ear­li­er.

The pres­i­dent will meet with Er­ck face-to-face to “ex­change opin­ions on the ex­pan­sion of the vac­cine pro­duc­tion part­ner­ship with No­vavax and dis­cuss ways to ad­vance the adop­tion, in­clud­ing an ear­li­er reg­u­la­to­ry ap­proval,” spokesper­son Park Kyung-mee said, per the Ko­rea Her­ald.

The vac­cine sub­sidiary of Ko­rea’s SK Group ex­pand­ed on its orig­i­nal man­u­fac­tur­ing pact with No­vavax back in Feb­ru­ary, giv­ing it a li­cense to man­u­fac­ture and com­mer­cial­ize NVX-CoV2373. SK con­cur­rent­ly struck an agree­ment to sup­ply the Ko­re­an gov­ern­ment with 40 mil­lion dos­es of the vac­cine. — Nicole De­Feud­is

*A pre­vi­ous ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed that there is a surge of Covid-19 cas­es in South Africa. A cor­rec­tion has been made to re­flect that the coun­try is not cur­rent­ly in a surge, but has the high­est case count on the con­ti­nent. 

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.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.