WuXi Bi­o­log­ics in­spec­tion rais­es prospects for get­ting off US 'un­ver­i­fied list' — re­port

WuXi Bi­o­log­ics may be inch­ing clos­er to work­ing its way off the US “un­ver­i­fied list,” an event that wiped out some $10 bil­lion in mar­ket val­ue ear­li­er this year.

Reuters is re­port­ing that Chi­nese of­fi­cials al­lowed a US ex­port con­trol of­fi­cer to con­duct an in­spec­tion in the city of WuXi, which the wire ser­vice iden­ti­fied as WuXi Bi­o­log­ics, cit­ing an un­named source. And the re­port al­so quot­ed a US ex­port con­trol of­fi­cer who not­ed that an in­spec­tion in An­hui may fol­low, un­less Covid in­ter­feres again.

The lack of in­spec­tions — used to ver­i­fy a com­pa­ny’s “le­git­i­ma­cy and re­li­a­bil­i­ty” — trig­gered tighter ex­port con­trols on WuXi Bi­o­log­ics, which builds drug man­u­fac­tur­ing fa­cil­i­ties and pro­vides equip­ment to com­pa­nies around the world.

Covid-19 has thrown the in­spec­tion process re­quired for cer­ti­fi­ca­tion in­to tur­moil as Chi­nese au­thor­i­ties have strict­ly en­forced lock­downs through­out the coun­try dur­ing the most re­cent out­break. That led to the un­ver­i­fied list for WuXi Bi­o­log­ics in Shang­hai and WuXi, where it was one of two com­pa­nies cit­ed.

Re­cent moves to add com­pa­nies to the US un­ver­i­fied list came amid a rise in ten­sion be­tween Chi­na and the US. Chi­nese of­fi­cials have harsh­ly crit­i­cized the move, but the Reuters re­port in­di­cates lit­tle flex­i­bil­i­ty on the US’s part.

“Covid aside, it’s re­al­ly de­pen­dent on them to agree to sched­ule the pend­ing end-use checks that we have,” the of­fi­cial said, ac­cord­ing to Reuters.

At the time, WuXi Bi­o­log­ics dis­count­ed the im­pact of the move.

So­cial im­age: WuXi web­site

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

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Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has approved the world’s first gene therapy for hemophilia B, ushering into the market a treatment that’s historic in both what it promises to do and how much it will cost.

CSL will be marketing the drug, Hemgenix, at a list price of $3.5 million — which sets a new record for the most expensive single-use gene therapy in the US.

In a statement provided to Endpoints News, the Australian company noted that the current costs of treating people with moderate to severe hemophilia B can be significant over a lifetime. By some estimates, healthcare systems could spend more than $20 million per person.

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Image: Shutterstock

MIT re­searchers re­veal DNA "Paste" tech be­hind lat­est gene edit­ing start­up

MIT scientists have developed a tool that they say can insert large gene sequences where they want in the genome.

In a paper published Thursday in Nature Biotechnology, MIT fellows Omar Abudayyeh, Jonathan Gootenberg and colleagues detail a technology they call PASTE, which they say can potentially be used to insert long strands of DNA and treat genetic diseases caused by many different mutations, such as cystic fibrosis and Leber congenital amaurosis, a rare eye disorder that causes blindness.

Elon Musk (GDA via AP Images)

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Almost all of the drug industry’s biggest advertisers cut their spending on Twitter to zero or near-zero over the last two weeks amid worries about impersonation of their brands by pranksters and the future of the social media company.

Among 18 of the biggest pharmaceutical advertisers in the US market, 12 cut their Twitter ad spending to nothing for the week beginning Nov. 14, according to Pathmatics, which tracks data on prescription drug ad spending as well as general corporate advertising. The list of drugmakers cutting spending to zero includes Merck, AstraZeneca, Eli Lilly, Novartis, Pfizer and others.

Rob Davis, Merck CEO

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Merck is making an acquisition, the Big Pharma announced before Monday’s opening bell. No, Seagen is not entering the fold, as had been speculated for quarters.

Folding under Merck’s wings will be Pfizer-backed Imago BioSciences. For nearly a year, Merck CEO Rob Davis has been saying the pharma giant needs to “do more” on the business development front after its 2021 $11.5 billion acquisition of Acceleron.

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Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

As the Japanese conglomerate Fujifilm continues to invest heavily in its CDMO arm, one of its manufacturing divisions is teeing up a major investment.

Fujifilm Irvine Scientific announced on Tuesday that parent Fujifilm is making a $188 million investment to build a cell culture media manufacturing site in the Research Triangle Park in North Carolina. The new site will mark Fujifilm Irvine’s fifth manufacturing site globally and its second in the US.

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

A day before Thanksgiving, J&J’s Janssen has a new cut of Phase III Spravato data to be grateful for.

The pharma giant announced on Wednesday that its nasal spray, also known as esketamine, beat extended-release quetiapine, previously sold by AstraZeneca as Seroquel XR, in treatment-resistant depression (TRD). Of 676 adults, a significantly higher number of patients on Spravato were able to achieve remission and avoid relapse after 32 weeks, according to J&J.

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

A cell therapy outfit in California that manufactures a human umbilical cord derived cellular product and exosome products is facing a warning from the FDA over several major observations related to quality.

The FDA notes the site’s “deficient donor screening practices, inadequate aseptic practices, unvalidated manufacturing,” and the “risk that your products may be contaminated with microorganisms or have other serious product quality defects.”

Dermavant Sciences' first consumer TV ad for its Vtama psoriasis med shows people ready for a new topical treatment.

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

Dermavant Sciences has been marketing its first product, psoriasis med Vtama, to dermatologists for months, but on Tuesday it rolled out its first consumer campaign. The debut DTC effort including a streaming TV commercial encourages patients to a “Topical Uprising” in a nod to Vtama being a topical cream.

In the new commercial, a swell of people discards scarves and jacket coverings, gathering in the street to converge on a pharmacy to demand a steroid-free prescription. A moment of levity follows when a pharmacist says, “You know you can just talk to your doctor, right?” The gathered crowds collectively says, “Oh.”

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