In a sup­ply chain short­age workaround, Aus­trali­a's Vic­to­ria state aims to build its own mR­NA fa­cil­i­ty

As coun­tries all around the world have ex­pe­ri­enced trou­bles with vac­cine short­ages, Aus­tralia’s Vic­to­ria state is de­vel­op­ing its own mR­NA man­u­fac­tur­ing fa­cil­i­ty in an ef­fort to up its num­ber of vac­ci­nat­ed res­i­dents.

Vic­to­ria will spend $39 mil­lion to set up the fa­cil­i­ty, which could be the first in the south­ern hemi­sphere, Reuters re­port­ed. The mR­NA tech­nol­o­gy is used in the Pfiz­er-BioN­Tech and Mod­er­na vac­cines, and has got­ten more at­ten­tion, as ade­n­ovirus-based vac­cines from As­traZeneca and J&J have had re­ports of rare, but sim­i­lar blood clots in some pa­tients. There have been no re­ports of ma­jor side ef­fects in ei­ther Mod­er­na or Pfiz­er’s jab.

Lo­cal man­u­fac­tur­ing ca­pa­bil­i­ty would avoid glob­al sup­ply chain is­sues and “pro­vide vac­cine se­cu­ri­ty,” a re­lease from the Vic­to­ri­an gov­ern­ment said. Act­ing Pre­mier James Mer­li­no said that it would like­ly take a year for vac­cines to be made in the coun­try, ac­cord­ing to Reuters.

The As­traZeneca vac­cine is pro­duced in Aus­tralia, but is on­ly ad­min­is­tered to those over the age of 50 right now. The coun­try’s virus num­bers have been low, com­pared to the US. As of Tues­day, there were 186 ac­tive cas­es in the en­tire coun­try. There have been 29,578 to­tal cas­es, 910 deaths and 47 to­tal hos­pi­tal­iza­tions due to the virus. Just one case has been ac­quired lo­cal­ly in the past week, ac­cord­ing to Aus­tralian health of­fi­cials.

“There are ma­jor ad­van­tages to this tech­nol­o­gy in­clud­ing high ef­fi­ca­cy, rapid speed in de­vel­op­ment, and flex­i­ble man­u­fac­tur­ing process­es,” min­is­ter for health Mar­tin Fo­ley said in a state­ment. “Vic­to­ria is well po­si­tioned to be at the fore­front of this ef­fort.”

Near­ly 1.3 mil­lion Covid-19 vac­cine dos­es have been ad­min­is­tered as of April 14, ac­cord­ing to health of­fi­cials. That’s far short of the Aus­tralian gov­ern­ment’s goal of 4 mil­lion by the end of March.

Aus­tralia re­strict­ed the use of As­traZeneca’s vac­cine last month, and some ship­ments of the vac­cine in­tend­ed to come from Italy have been blocked by EU of­fi­cials. The short­age has been wide­spread, as Cana­da and Spain, among oth­er coun­tries, have strug­gled to ob­tain an ad­e­quate num­ber of dos­es.

A study in the UK has ex­plored the use of mix­ing 2 dif­fer­ent Covid-19 vac­cines to in­crease the num­ber of peo­ple vac­ci­nat­ed while dos­es are in short sup­ply. Mod­er­na — an mR­NA-based vac­cine — and No­vavax — a pro­tein-based vac­cine that teach­es the im­mune sys­tem to make an­ti­bod­ies — were added to that study a week ago.

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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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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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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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.