Mod­er­na bags an­oth­er US CD­MO to help with fill-fin­ish work for its vac­cine amid boost­er push

Mod­er­na has en­list­ed an­oth­er CD­MO to ramp up Covid-19 vac­cine man­u­fac­tur­ing ca­pa­bil­i­ty in its ef­fort to pro­vide 3 bil­lion dos­es in 2022.

Juan An­dres

Start­ing in Q3, Ther­mo Fish­er Sci­en­tif­ic will car­ry out fill-fin­ish, la­bel­ing and pack­ag­ing ser­vices to sup­port Mod­er­na at the CD­MO’s Greenville, NC site, the com­pa­ny said in a re­lease.

“Ther­mo Fish­er has been a crit­i­cal part­ner in sup­ply­ing raw ma­te­ri­als for our COVID-19 vac­cine and we are now pleased to fur­ther ex­pand our re­la­tion­ship as an im­por­tant man­u­fac­tur­ing part­ner as well,” said Juan An­dres, Mod­er­na’s chief tech­ni­cal op­er­a­tions and qual­i­ty of­fi­cer, in a state­ment. “The ad­di­tion of Ther­mo Fish­er to our net­work will sup­port our ef­forts to scale up our man­u­fac­tur­ing abil­i­ty.”

Mod­er­na has al­so reached an agree­ment with Lon­za to es­tab­lish a new pro­duc­tion line at the com­pa­ny’s Geleen, Nether­lands site, which will add an ad­di­tion­al 300 mil­lion dos­es per year in ca­pac­i­ty.

The pro­duc­tion in Geleen will help Mod­er­na halve the dosage of its vac­cine for pe­di­atric use and as boost­ers against vari­ants. Mod­er­na has stud­ied low­er-dose ver­sions of its jab to help stretch out the sup­ply. So far, dos­es have con­sist­ed of 100 mi­cro­grams, but Mod­er­na has al­so teamed with ROVI in Grana­da, Spain, to sup­ply 600 mil­lion 50 mi­cro­gram dos­es per year. Both of those pacts will be op­er­a­tional be­fore the end of 2021, the com­pa­ny said in the re­lease.

ROVI and France’s Re­ci­pharm have al­ready been per­form­ing fill-fin­ish ser­vices for Mod­er­na’s vac­cine in Eu­rope. These moves are the lat­est an­nounce­ments in a rapid ramp-up in pro­duc­tion.

Last week, Mod­er­na and Sam­sung Bi­o­log­ics inked a deal for fill-fin­ish du­ties at its In­cheon, South Ko­rea plant. Mod­er­na’s al­so pledged to dou­ble its Mass­a­chu­setts lab space for a 50% in­crease in man­u­fac­tur­ing, dou­ble man­u­fac­tur­ing at Lon­za’s Visp, Switzer­land site and Rovi’s Spain fa­cil­i­ty. In April, Sanofi signed on with Mod­er­na to pro­duce its vac­cine. That marked the third com­pa­ny Sanofi part­nered with to pro­duce the Covid-19 shot af­ter its own at­tempts failed. The French drug­mak­er is al­so pro­duc­ing Pfiz­er-BioN­Tech and J&J’s jab at its man­u­fac­tur­ing sites, in­clud­ing the one in Ridge­field, NJ.

Catal­ent — a Mod­er­na part­ner — and Ster­ling are work­ing to­geth­er to pro­vide more ul­tra-low tem­per­a­ture freez­ers for the CD­MO to pre­serve high­ly tem­per­a­ture-sen­si­tive ma­te­r­i­al used in vac­cines.

Mean­while, Mod­er­na’s pledged 50o mil­lion dos­es to CO­V­AX ear­ly last month. Those dos­es will be sold at the low­est tiered price, and go to 92 of the low­est in­come coun­tries by the end of next year. Ac­cord­ing to the agree­ment, 34 mil­lion of those dos­es are set to be de­liv­ered in Q4. Gavi, the vac­cine al­liance has al­ready shipped 49 mil­lion Covid-19 vac­cines do­nat­ed from Pfiz­er, As­traZeneca and the Serum In­sti­tute of In­dia.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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J. Kelly Ganjei, AmplifyBio CEO and president

Af­ter pri­vate and state in­vest­ment, Am­pli­fy­Bio plans to ex­pand to an­oth­er Colum­bus, OH lo­ca­tion

An Ohio-based biotech spinout is garnering even more investment and space even after only being around for about a year.

AmplifyBio, a CRO and R&D biotech, has received a nine-figure investment to expand its facilities to a second location in New Albany, a suburb of the state capital of Columbus.

The company is receiving an investment of around $150 million to establish a new 350,000-square-foot facility. With this investment, the company is also expected to create over 200 new jobs both at its new location and at an existing location in West Jefferson, another Columbus suburb. That location, which has 220,000-square-feet of space for the young biotech, is the headquarters for nonprofit Battelle, which spun out AmplifyBio last year.

Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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