Seat­tle Chil­dren's col­lab­o­ra­tion to dive in­to cell ther­a­py man­u­fac­tur­ing; Af­ter suc­cess in court, Te­va found guilty in NY

A cell and gene ther­a­py com­pa­ny is ex­tend­ing its col­lab­o­ra­tion with Seat­tle Chil­dren’s Hos­pi­tal to es­tab­lish man­u­fac­tur­ing prac­tices for cell ther­a­py, the com­pa­ny an­nounced Tues­day.

Bi­o­Life’s new lentivi­ral vec­tor man­u­fac­tur­ing site, dubbed Vec­tor­Works, will be used to find best prac­tices in bio­p­reser­va­tion and closed-sys­tem man­u­fac­tur­ing with the in­tro­duc­tion and in­te­gra­tion of Sex­ton’s AF-500. Seat­tle Chil­dren’s, and its sub­sidiary Seat­tle Chil­dren’s Ther­a­peu­tics, have used Bi­o­Life’s CryoStar for freez­ing me­dia for sev­er­al years in clin­i­cal ap­pli­ca­tions and tri­als to im­prove the post-thaw vi­a­bil­i­ty and re­cov­ery of cells.

“This ex­pand­ed col­lab­o­ra­tion is an ex­cit­ing step for Seat­tle Chil­dren’s Ther­a­peu­tics as we work to­wards de­vel­op­ing closed-sys­tem process­es for cell ther­a­py man­u­fac­tur­ing,” said Matt Sel­l­ey, di­rec­tor of GMP man­u­fac­tur­ing for Seat­tle Chil­dren’s. “Lentivi­ral vec­tor man­u­fac­tur­ing is a crit­i­cal com­po­nent of the cell pro­duc­tion process.”

The col­lab­o­ra­tion will com­bine AF-500 with Seat­tle Chil­dren’s man­u­fac­tur­ing ex­per­tise. AF-500 can fill and seal up to 560 vials in 90 min­utes, the com­pa­ny says. The CellSeal Con­nect, which builds up­on the tech­nol­o­gy used for the orig­i­nal CellSeal cryo­genic stor­age vials, al­lows for a closed-sys­tem re­trieval of vi­ral vec­tors.

Af­ter big wins in court, Te­va found guilty in NY

Drug man­u­fac­tur­er Te­va Phar­ma­ceu­ti­cals was found guilty by a New York ju­ry for cre­at­ing a pub­lic nui­sance by man­u­fac­tur­ing opi­oid pills that have killed thou­sands of peo­ple across the state, and what the CDC es­ti­mates are more than 600,000 peo­ple across the coun­try.

The man­u­fac­tur­er re­leased a press re­lease stat­ing that it “strong­ly dis­agrees” with the out­come, and is prepar­ing an ap­peal, as well as pur­su­ing a mis­tri­al.

“In NY, the plain­tiffs pre­sent­ed no ev­i­dence of med­ical­ly un­nec­es­sary pre­scrip­tions, sus­pi­cious or di­vert­ed or­ders, no ev­i­dence of over­sup­ply by the de­fen­dants – or any in­di­ca­tion of what vol­umes were ap­pro­pri­ate – and no causal re­la­tion­ship be­tween Te­va’s con­duct in­clud­ing its mar­ket­ing and any harm to the pub­lic in the state,” the state­ment said.

In No­vem­ber, Te­va was found not guilty in Cal­i­for­nia by Or­ange Coun­ty, Los An­ge­les Coun­ty, the City of Oak­land, and San­ta Clara Coun­ty on grounds that it caused a pub­lic nui­sance. A su­pe­ri­or court judge in Cal­i­for­nia ruled that opi­oid man­u­fac­tur­ers were not re­spon­si­ble for the cri­sis be­cause of their mis­lead­ing mar­ket­ing. The mu­nic­i­pal­i­ties sought $50 bil­lion in dam­ages from J&J, Ab­b­Vie, En­do and Te­va.

Mean­while in Ok­la­homa, the state’s Supreme Court over­turned an ear­ly rul­ing, stat­ing that the pub­lic nui­sance law in Ok­la­homa doesn’t ex­tend to man­u­fac­tur­ing, mar­ket­ing and sell­ing pre­scrip­tion opi­oids.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

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.

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

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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

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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)

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

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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.

Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

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Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.