Covid vac­cine roundup: US vac­cine sup­plies grow, but ex­perts warn of po­ten­tial hic­cups in sup­ply chain; Emer­gent touts grow­ing Covid vac­cine ca­pac­i­ty

The Biden ad­min­is­tra­tion has been rais­ing hopes in the US that there will be am­ple vac­cine sup­plies to in­oc­u­late more than 250 mil­lion Amer­i­can adults by May. There have been new deals with Mod­er­na and Pfiz­er to ramp up 400 mil­lion dos­es, to cov­er 200 mil­lion, with 100 mil­lion sin­gle-shot vac­cines from J&J top fin­ish the job.

But some ex­perts are sound­ing a warn­ing that there could be a lot more to this than sim­ply sign­ing con­tracts. Vac­cine man­u­fac­tur­ing is not an easy busi­ness.

“You can be go­ing along and get­ting a cer­tain yield and then all of the sud­den your yield drops and you don’t know why,” vac­cine pro­duc­tion con­sul­tant Robert Van Ex­an tells USA To­day. “Test de­lays or fail­ures, raw ma­te­r­i­al sup­ply chain, lot fail­ures and yield prob­lems are just some of the ex­am­ples of things that can re­sult in sup­ply dis­rup­tions.”

Emer­gent touts abil­i­ty to man­u­fac­ture more than 1B dos­es of Covid vac­cine each year

Af­ter ink­ing a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next 2 years, Emer­gent BioSo­lu­tions says that it has now de­vel­oped enough ca­pac­i­ty to make more than a bil­lion dos­es of vac­cine a year.

“We are op­er­at­ing at a lev­el where our ca­pac­i­ty is well in ac­cess of 1 bil­lion dos­es an­nu­al­ly for those prod­ucts,” CEO Bob Kramer said in a “Mad Mon­ey” in­ter­view.

Emer­gent al­so has an arrange­ment to make As­traZeneca’s vac­cine, which is be­ing dis­trib­uted around the world.

Once the ini­tial roll­out is fin­ished it’s like­ly that we’ll see bil­lions of more boost­er shots on of­fer every year, mark­ing a ma­jor new add-on to the world’s vac­cine busi­ness.

EU au­dit in In­dia could be tied to fresh sup­plies — re­port

EU reg­u­la­tors are au­dit­ing the Serum In­sti­tute of In­dia’s man­u­fac­tur­ing site.

There’s no word in the re­port just why they’re do­ing the au­dit, but Reuters notes that it could be a pre­lim­i­nary step to al­low­ing in sup­plies of As­traZeneca’s vac­cine shot, de­vel­oped with Ox­ford. The SII is mak­ing sup­plies for de­vel­op­ing na­tions, though there have been re­ports that its first du­ty is to sup­ply the sub­con­ti­nent.

As­traZeneca has seen some sig­nif­i­cant back­lash against the vac­cine, as doubts were raised about its ef­fi­ca­cy among old­er peo­ple as well as the new vari­ants that are mak­ing the rounds. Ger­many, though, just cleared it for those over 65, sig­nal­ing a more open at­ti­tude that could spark wider us­age on the con­ti­nent.

WTO wants vac­cine man­u­fac­tur­ers to triple glob­al pro­duc­tion in cri­sis

While vac­cine sup­plies are flow­ing in grow­ing quan­ti­ties to the most af­flu­ent coun­tries, poor na­tions are find­ing them­selves at the back of the line. Now the head of the World Trade Or­ga­ni­za­tion is urg­ing its mem­ber na­tions to ne­go­ti­ate new li­cens­ing deals while push­ing vac­cine man­u­fac­tur­ers to triple pro­duc­tion from the usu­al 3.5 bil­lion vac­cine dos­es a year to 10 bil­lion.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Paul Hudson, Sanofi CEO (ROMUALD MEIGNEUX/Sipa via AP Images)

Sanofi and Am­gen are bring­ing cash to cov­er the ta­ble stakes for the Hori­zon M&A game

With the market cap on Horizon Therapeutics $HZNP pushed up to the $23 billion mark today, one of the Big Pharmas in the hunt for a major league buyout deal signaled it’s playing the M&A game with cash.

Paris-based Sanofi, where CEO Paul Hudson has been largely focused on some risky biotech acquisitions to win some respect for its future pipeline prospects, issued a statement early Friday — complying with rule 2.12 of the Irish takeover rules — making clear that while the certainty or size of an offer can’t be determined, any offer “will be solely in cash.” And Amgen CEO Robert Bradway came right in behind him, filing a statement on the London Stock Exchange overnight that any offer they may make will “likely” be in cash as well.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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As the amox­i­cillin short­age drags on, sev­er­al sen­a­tors pres­sure FDA and HHS for so­lu­tions

With the US staring down several drug shortages this year, one in particular is now catching lawmakers’ attention.

A bipartisan group of senators sent a letter to HHS Secretary Xavier Becerra and FDA commissioner Robert Califf expressng “strong concern” about the amoxicillin shortage for patients and general public health. Sens. Amy Klobuchar (D-MN), Sherrod Brown (D-OH), Ed Markey (D-MA) and Bill Cassidy (R-LA) are pushing for FDA and HHS to start working more forcefully to address the amoxicillin shortage along with the other drug shortages.

Man­u­fac­tur­ing roundup: Touch­light nets $2M grant from the Gates Foun­da­tion; Ex­per­ic clos­es $14M Se­ries B

The manufacturer of the “Doggybone DNA” synthetic vector has netted deals with big names, the latest of which is a grant from the Bill & Melinda Gates Foundation to help further Touchlight’s “preclinical development” of its vaccine platform.

The vaccine program aims to build on evidence that the synthetic DNA the company produces can produce strong antibodies and durable T cell responses following vaccine administration.

Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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