Covid-19 man­u­fac­tur­ing roundup: Biden pumps $500M in­to do­mes­tic test­ing pro­duc­tion; Val­ne­va mulls pro­duc­tion deal

The US De­part­ment of Health and Hu­man Ser­vices has in­vest­ed an ad­di­tion­al $562 mil­lion in US com­pa­nies to boost the do­mes­tic man­u­fac­tur­ing of Covid-19 tests and sup­plies, it an­nounced last week.

A dozen com­pa­nies were re­cip­i­ents of the fund­ing, which in­clud­ed mon­ey to sup­port the man­u­fac­tur­ing of pipette tips, pro­tec­tive pack­ag­ing, swabs and reagents used to de­tect the virus in sam­ples.

Among the re­cip­i­ents were Ora­Sure Tech­nolo­gies, which re­ceived $109 mil­lion to retro­fit a man­u­fac­tur­ing fa­cil­i­ty and build a new one to up do­mes­tic man­u­fac­tur­ing for rapid anti­gen self-tests; Cepheid, which land­ed $63.8 mil­lion to pro­duce plas­tic over mold; and Nalge Nunc In­ter­na­tion­al, a sub­sidiary of Ther­mo Fish­er Sci­en­tif­ic, which took home $192.5 mil­lion to ramp pipette tip man­u­fac­tur­ing for sam­ple col­lec­tion and test pro­cess­ing.

Oth­er com­pa­nies that re­ceived fund­ing in­clude:

  • Lu­mi­nos­tics, $2 mil­lion
  • Lab­con, $59.3 mil­lion
  • Prince­ton Bio­Meditech, $9.9 mil­lion
  • Steri­pack, $14.7 mil­lion
  • US Cot­ton,$6.5 mil­lion
  • Porex, $16.2 mil­lion
  • Eu­rofins Ge­nomics, $30 mil­lion.

Pres­i­dent Joe Biden’s ad­min­is­tra­tion is mov­ing to in­vest as much as $3 bil­lion in­to the rapid test­ing ef­forts, in hopes of qua­dru­pling the at-home test sup­ply in time for the hol­i­day sea­son. The funds have been pulled from the Amer­i­can Res­cue Plan Act.

Val­ne­va could turn to CMO if de­mand calls for part­ner­ship

Amid high de­mand for its Covid-19 vac­cine fol­low­ing pos­i­tive Phase III tri­al re­sults, Val­ne­va could land a deal with a con­tract man­u­fac­tur­ing or­ga­ni­za­tion to up its pro­duc­tion ca­pac­i­ty for the jab.

The com­pa­ny an­nounced its jab had in­duced su­pe­ri­or neu­tral­iz­ing an­ti­body titer lev­els over As­traZeneca’s AZD1222 when pit­ted head-to-head in the tri­al, though both treat­ment groups saw a sim­i­lar num­ber of in­fec­tions. The com­pa­ny is tout­ing a “sig­nif­i­cant­ly more fa­vor­able” tol­er­a­bil­i­ty pro­file.

Val­ne­va start­ed com­mer­cial­ly man­u­fac­tur­ing VLA2001 in Liv­ingston, Scot­land, in Jan­u­ary. The com­pa­ny’s Sol­na, Swe­den site car­ries out fill-fin­ish op­er­a­tions.

On Sept. 13, Val­ne­va an­nounced that the UK back out of its deal for 100 mil­lion dos­es.

Alexander Lefterov/Endpoints News

A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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In a set­back, FDA or­ders Gilead to hit the brakes on their late-stage, $5B can­cer play

Gilead’s $5 billion drug magrolimab has run into a serious setback.

The FDA ordered Gilead to halt enrollment on their studies of the drug in combination with azacitidine after investigators reports revealed an “apparent imbalance” in the suspected unexpected serious adverse reactions between study arms. And the halt is raising questions about Gilead’s plans for a quick pitch to regulators.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Nabiha Saklayen, Cellino co-founder and CEO (via Cellino)

Backed by Bay­er's Leaps, Boston-based Celli­no lands $80M for cell ther­a­py-in-box

The summer before Cellino CEO and co-founder Nabiha Saklayen started at Harvard, she lost her grandmother following complications to diabetes. Before then, she hadn’t taken a biology class since ninth or tenth grade — the mark of a classic physicist — but it was then she decided she wanted the rest to sit at the intersection of the two for the rest of her career

Combine that with being across the way from the University’s stem cell institute in Cambridge, and you get the birth of Cellino, an autonomous cell therapy manufacturing company that just announced the closing of its Series A.

FDA's do­mes­tic in­spec­tion hold will con­tin­ue un­til Feb­ru­ary

Amid a backlog of inspections, the FDA has announced that it will extend its pause of domestic inspections not considered mission-critical due to the outbreak of the Omicron variant.

While the agency will continue both foreign and domestic inspections deemed mission-critical, others will be paused through at least Feb. 4, and restart as soon as possible after that.

Previously planned foreign inspections will carry on as long as they’re in a country that has been cleared, and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation — otherwise, they’ll be rescheduled. The FDA hopes to return to a regular cadence for foreign inspections in April.