Cy­ti­va opens doors at Cardiff site as part of $1.5B glob­al ex­pan­sion

In a Sep­tem­ber in­ter­view with End­points News, Cy­ti­va CMO Conor McK­ech­nie said that the com­pa­ny was fo­cus­ing on in-re­gion, for-re­gion man­u­fac­tur­ing as the bio­phar­ma world felt the im­pact of sup­ply woes that af­fect­ed the en­tire world.

How­ev­er, the com­pa­ny is now tak­ing its next step for­ward in sup­port­ing the glob­al in­dus­try with the open­ing of a new 118,400 square-foot site last week in Cardiff, Wales fo­cused on man­u­fac­tur­ing sin­gle-use bio­pro­cess­ing tech. Em­ploy­ees at the site have al­ready start­ed to make mix­er bags, flow kits and tub­ing as­sem­blies to ship to cus­tomers for the de­vel­op­ment of Covid-19 vac­cines, among oth­er bio­phar­ma­ceu­ti­cals. The site will ser­vice cus­tomers around the world, but pro­vide cus­tomers in the UK and Eu­rope with a clos­er op­er­a­tion to work along­side.

“Since 2020, we have in­vest­ed and sig­nif­i­cant­ly in­creased glob­al ca­pac­i­ty to ad­dress our cus­tomers’ grow­ing needs. We con­tin­ue to ex­pand with new man­u­fac­tur­ing sites, such as that in Cardiff,” Mary Blenn, Cy­ti­va’s VP of the glob­al sup­ply chain, said in a state­ment. “This fa­cil­i­ty al­so gives us an en­hanced pres­ence in the UK, al­low­ing us to pro­vide more re­gion­al op­tions to our cus­tomers there.”

The sin­gle-use tech made in Cardiff will be used by Cy­ti­va’s clients for can­cer, au­toim­mune and rare dis­ease drugs, in ad­di­tion to Covid-19 vac­cines.

In Au­gust, Cy­ti­va out­lined a plan to in­vest $1.5 bil­lion in­to its glob­al op­er­a­tions, in­clud­ing $400 mil­lion for cell cul­ture me­dia and $300 mil­lion for sin­gle-use tech­nolo­gies. Part of the mis­sion is to build up the team in Cardiff. Cy­ti­va is look­ing to hire man­u­fac­tur­ing staff, ware­house work­ers, ma­te­r­i­al han­dlers and R&D sci­en­tists, the com­pa­ny said. Right now on the Dana­her web­site, there are 27 jobs post­ed, rang­ing from glob­al in­fra­struc­ture IT an­a­lyst to ware­house op­er­a­tor to bi­ol­o­gy pro­duc­tion su­per­vi­sor.

In just the last six months, 100 of those roles have been filled al­ready, Blenn said in an email to End­points. The ef­forts are go­ing to con­tin­ue over the next 18 months. The Cardiff site is of­fer­ing in-per­son train­ing and sup­port for roles such as ma­te­r­i­al han­dlers and ware­house op­er­a­tors.

“The bio­phar­ma skills gap is one of the biggest chal­lenges fac­ing the glob­al in­dus­try right now,” Blenn said. “We know re­cruit­ing the right tal­ent starts ear­ly and that’s why we are proud to have links with aca­d­e­m­ic in­sti­tu­tions and in­dus­try bod­ies such as the Life Sci­ences Hub Wales in Cardiff who can sup­port our hir­ing plans. In Cardiff, we are re­cruit­ing spe­cial­ist roles such as in R&D but we al­so need a great many shopfloor work­ers –roles such as ware­house op­er­a­tors and ma­te­r­i­al han­dlers.”

In Ju­ly, a re­port from the BioIn­dus­try As­so­ci­a­tion showed that the UK’s life sci­ences sec­tor was about to en­ter a “gold­en age,” thanks, in part, to a strong de­mand that re­sult­ed in £1.6 bil­lion raised in three months, the largest dol­lar amount ever record­ed for a quar­ter. UK com­pa­nies ac­count­ed for 60% of all biotech ven­ture cap­i­tal in­vest­ed in Eu­rope in 2021. The coun­try ranked third in the world in IPO ac­tiv­i­ty, be­hind Mass­a­chu­setts and San Fran­cis­co, Clar­i­vate’s head of thought lead­er­ship Mike Ward said.

“The UK biotech sec­tor con­tin­ues to main­tain its fundrais­ing mo­men­tum and re­mains one of the world’s lead­ing biotech hotspots. In­deed, in the first half of 2021, UK biotechs raised more mon­ey from VC sources than for the whole of 2020.”

An em­pha­sis has been placed on sus­tain­abil­i­ty. There are en­er­gy me­ters through­out the site to en­sure op­ti­miza­tion of elec­tric­i­ty and re­duce the over­all con­sump­tion of en­er­gy, and the team is in­ves­ti­gat­ing “dy­nam­ic” clean­room con­trols, which Cy­ti­va says would re­duce pow­er use up to 60%. Neigh­bor­ing of­fices will run “very close” to car­bon neu­tral. The com­plet­ed site will help up Cy­ti­va’s sin­gle-use ca­pac­i­ty by about 20%.

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.

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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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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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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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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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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