Man­u­fac­tur­ing brief­ing: Af­ter J&J-Emer­gent mix­up, few­er dos­es ex­pect­ed in US next week; Boehringer taps Ox­ford for vi­ral vec­tors

Amer­i­cans will see a sig­nif­i­cant drop in J&J Covid-19 vac­cines al­lo­cat­ed next week, ac­cord­ing to da­ta from the CDC.

A re­port from Reuters not­ed that just 785,500 dos­es will be doled out, com­pared to 4.95 mil­lion this week.

The New York Times pre­vi­ous­ly re­port­ed that a mix­up at a Bal­ti­more Emer­gent fa­cil­i­ty re­sult­ed in 15 mil­lion fu­ture dos­es be­ing ru­ined. Cal­i­for­nia is the main re­cip­i­ent of the J&J vac­cine, fol­lowed by Texas and Flori­da, Reuters said.

Weeks af­ter Sanofi backed out of vi­ral vec­tors deal, Ox­ford inks agree­ment with Boehringer In­gel­heim

Ox­ford Bio­med­ica an­nounced Tues­day that it signed a new three-year deal with Boehringer In­gel­heim for the man­u­fac­tur­ing and sup­ply of vi­ral vec­tors.

Ox­ford will man­u­fac­ture batch­es for Boehringer In­gel­heim for a sup­ply of var­i­ous types of vi­ral vec­tors, a re­lease said.

The deal is the lat­est in a part­ner­ship be­tween the two com­pa­nies start­ed in 2018.

“We now have a port­fo­lio of part­ner­ships spread across de­vel­op­ment of CAR-Ts, TCR-Ts and in vi­vo gene ther­a­peu­tics, util­is­ing lentivi­ral vec­tors,” Ox­ford CEO John Daw­son said in a state­ment. “We are proud to part­ner with Boehringer In­gel­heim, a busi­ness with proven ex­cel­lence in com­plex man­u­fac­tur­ing projects, as well as ex­per­tise in de­vel­op­ing in­no­v­a­tive med­i­cines for pa­tients with se­ri­ous un­met med­ical needs.”

The UK tries to spur man­u­fac­tur­ing in­vest­ment at home with new grant fund

In a move to en­cour­age man­u­fac­tur­ing at home, the UK gov­ern­ment an­nounced a fund through which man­u­fac­tur­ers can now ap­ply for a share of up to $27.5 mil­lion.

The mon­ey is open to pri­vate man­u­fac­tur­ers in hu­man med­i­cine, med­ical di­ag­nos­tics and medtech. The pro­gram is geared at cre­at­ing jobs and eco­nom­ic growth, as well as cre­ate prod­ucts that will “con­tribute to the build­ing of the UK’s health re­silience.”

Those who re­ceive fund­ing will have so for one year. To be el­i­gi­ble, ap­pli­cants must be able to spend the mon­ey be­fore next March. Busi­ness­es will have to con­firm that their el­i­gi­ble costs are greater than $10.99 mil­lion. Com­pa­nies must al­so be able to pro­ceed with the project, with­out de­lay, with­in four weeks.

Sup­ply chain com­pa­nies are not el­i­gi­ble for the fund­ing, and the mon­ey can­not be used for salaries, R&D or train­ing.

“Dur­ing the ap­pli­ca­tion process, you will al­so be asked to con­firm that the project can­not vi­ably pro­ceed with­out pub­lic sec­tor sup­port,” the scheme guid­ance states.

The ap­pli­ca­tion dead­line is June 30 at 11:59 p.m.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.