Paul Hudson, Sanofi CEO (Sipa via AP Images)

Paul Hud­son is more con­fi­dent in Sanofi's abil­i­ty to pro­duce a Covid-19 vac­cine — re­port

Sanofi CEO Paul Hud­son ex­pressed re­newed con­fi­dence Fri­day re­gard­ing its com­pa­ny’s Covid-19 vac­cine can­di­date be­ing de­vel­oped with GSK.

As the can­di­date is set to start clin­i­cal tri­als some­time next month, Hud­son told Reuters that Sanofi has seen pos­i­tive da­ta so far this sum­mer. That gus­to builds up­on com­ments he made in June about the high­er like­li­hood Sanofi pro­duces a vac­cine with greater than 70% ef­fi­ca­cy com­pared to ri­vals.

“The ear­ly da­ta is say­ing that we’re on the right track and that we have a vac­cine,” Hud­son told Reuters on Fri­day. “Our con­fi­dence has in­creased. We have work to do like every­body on man­u­fac­tur­ing in large vol­umes. But we will have one, maybe two vac­cines next year.”

Cur­rent­ly, the Sanofi/GSK can­di­date ranks 26th in End­points News’ Covid-19 vac­cine track­er.

The French phar­ma was slow out of the gate in the Covid-19 vac­cine race, part­ner­ing with GSK in April to com­bine its can­di­date with an ad­ju­vant from the British drug­mak­er. Though oth­ers in the field had net­ted con­tracts from Op­er­a­tion Warp Speed ear­li­er, Sanofi ul­ti­mate­ly scored one of the biggest deals worth $2.1 bil­lion.

Sanofi has al­so ne­go­ti­at­ed to sup­ply vac­cines to the UK, with talks in ad­vanced stages to pro­vide up to 300 mil­lion vac­cines to the Eu­ro­pean Union as well. How­ev­er, those talks have hit a snag, as the bloc is not plan­ning to of­fer full pro­tec­tion from civ­il li­a­bil­i­ty law­suits.

Ear­li­er this week, a re­port from the Fi­nan­cial Times said that the Eu­ro­pean vac­cines lob­by Vac­cines Eu­rope is push­ing the EU to do so, cir­cu­lat­ing a memo among mem­bers say­ing the “speed and scale of de­vel­op­ment and roll­out do mean that it is im­pos­si­ble to gen­er­ate the same amount of un­der­ly­ing ev­i­dence that nor­mal­ly would be avail­able through ex­ten­sive clin­i­cal tri­als and health­care providers build­ing ex­pe­ri­ence.” That would ul­ti­mate­ly cre­ate “in­evitable” risks.

The bloc is try­ing to come up with a plan to com­pen­sate drug­mak­ers, how­ev­er, giv­en the risks as­so­ci­at­ed with ac­cel­er­at­ed man­u­fac­tur­ing. Sanofi and GSK are two of sev­er­al high-pro­file mem­bers of Vac­cines Eu­rope, which al­so in­cludes Mer­ck, As­traZeneca and Pfiz­er.

“I think with the lev­el of pro­tec­tion, we have reached an ‘agreed lev­el.’ And I think that has al­lowed us to go for­ward and sign. But I am aware there are dif­fer­ent po­si­tions on how strong that is,” Hud­son told Reuters re­gard­ing the li­a­bil­i­ty is­sue.

Sanofi is cur­rent­ly de­vel­op­ing a sec­ond Covid-19 vac­cine can­di­date with the biotech Trans­late Bio, us­ing mR­NA tech­nol­o­gy. A few days ago, an SEC fil­ing from Trans­late said that ear­ly test­ing of that can­di­date in­duced an im­mune re­sponse in pri­mates, show­ing “high neu­tral­iz­ing titers that are com­pa­ra­ble to the up­per range of those ob­served in in­fect­ed hu­mans,” in­duc­ing “TH1-bi­ased T cell re­spons­es.”

The two com­pa­nies agreed to a $2 bil­lion-plus vac­cines R&D agree­ment back in June.

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

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.