Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Sanofi lands 3rd Covid-19 vac­cine man­u­fac­tur­ing part­ner as it works to push for­ward its own jab

As the de­mand for mR­NA-based Covid-19 vac­cines per­sists, Sanofi is jump­ing in­to the fray.

The French drug­mak­er has en­tered an agree­ment with Mod­er­na to man­u­fac­ture the com­pa­ny’s Covid-19 vac­cine. The agree­ment marks the third dif­fer­ent com­pa­ny Sanofi has paired with to man­u­fac­ture a Covid-19 vac­cine, since their own ef­fort to de­vel­op a pan­dem­ic in­oc­u­la­tion faced sig­nif­i­cant set­backs.

The com­pa­ny will per­form fill-and-fin­ish at its Ridge­field, NJ site to com­plete up to 200 mil­lion dos­es of the vac­cine. That will be­gin in Sep­tem­ber.

“Since the be­gin­ning of the pan­dem­ic, we have been mo­bi­liz­ing on mul­ti­ple fronts and we showed sol­i­dar­i­ty across the in­dus­try,” CEO Paul Hud­son said in a state­ment. “We are one of the few phar­ma­ceu­ti­cal com­pa­nies to lever­age many in­dus­tri­al part­ner­ships to im­prove eq­ui­table glob­al sup­ply and ac­cess to Covid-19 vac­cines, while in par­al­lel, al­so con­tin­u­ing to de­vel­op our 2 Covid-19 vac­cine pro­grams.”

In Feb­ru­ary, Sanofi an­nounced that it would sup­port man­u­fac­tur­ing for 12 mil­lion dos­es a month of J&J’s vac­cine at its man­u­fac­tur­ing site in France. Be­fore that, the com­pa­ny signed on to pro­vide 125 mil­lion dos­es of the Pfiz­er-BioN­Tech vac­cine for the EU, step­ping up as some coun­tries wor­ried if they’d re­ceive enough dos­es and Italy threat­ened le­gal ac­tion.

Its own at­tempt at a Covid-19 vac­cine, along­side Glax­o­SmithK­line, hit a ma­jor set­back in De­cem­ber, af­ter the com­pa­nies an­nounced the shot failed among adults old­er than 49 years old in an ear­ly study. A low im­mune re­sponse “like­ly due to suf­fi­cient con­cen­tra­tion of the anti­gen” was to blame, ac­cord­ing to re­searchers. The 2 com­pa­nies had an­tic­i­pat­ed get­ting hun­dreds of mil­lions of the vac­cine on the mar­ket to help parts of the world in dire need of pan­dem­ic help, and re­lied on a slow­er but more proven tech­nol­o­gy.

That vac­cine can­di­date us­es the same re­com­bi­nant pro­tein-based tech­nol­o­gy as 1 of the com­pa­ny’s sea­son­al flu vac­cines. In Feb­ru­ary, Sanofi an­nounced the start of a Phase II study with an im­proved anti­gen fo­mu­la­tion, and a to­tal of 720 par­tic­i­pants. The ear­li­est that vac­cine would be avail­able would be Q4 2021. It pre­vi­ous­ly was look­ing to head to Phase III tri­als in De­cem­ber 2020.

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

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, via Getty Images)

FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

As a matter of official policy, the FDA doesn’t comment about unapproved drugs and the data gathered to back them.

As an unofficial policy, though, the agency can still be provoked by a seemingly unending stream of promotional releases to call a company out for a complete and utter failure.

So it was today with CytoDyn, a biotech company that has a habit of blasting statements out about their drug leronlimab, which has been touted as a potential treatment for Covid-19.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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Charles Riv­er keeps adding on to its CD­MO arm, snatch­ing up a vi­ral vec­tor play­er for a tidy $350M

Contract researcher Charles River Laboratories has been on a roll recently to flesh out its manufacturing arm with a specific focus on its capabilities in gene therapy. Now, the firm is putting its name to a big check for a Maryland-based viral vector firm it thinks will add to its growing expertise in the field.

Charles River will dole out $292.5 million for gene therapy CDMO Vigene Biosciences with the possibility for an additional $57.5 million in performance-based payments, the companies said Monday. The deal will close at the start of Q3, a Charles River spokesman said.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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