FDA faults IQVIA for er­rors in opi­oid sales da­ta, calls for qual­i­ty re­view

The FDA is call­ing up­on IQVIA to re­view its da­ta qual­i­ty and method­olo­gies af­ter find­ing er­rors re­gard­ing sales vol­ume da­ta on cer­tain con­trolled sub­stance, in­clud­ing opi­oids. Cit­ing “se­ri­ous con­cerns about sys­temic is­sues with IQVIA’s da­ta and qual­i­ty con­trol pro­ce­dures,” the agency has re­quest­ed IQVIA run an in­de­pen­dent au­dit.

In a state­ment, IQVIA — the world’s largest clin­i­cal out­sourc­ing firm and a wide­ly used da­ta ven­dor — said it’s been ad­dress­ing the is­sue, which it had al­ready iden­ti­fied pri­or to the no­ti­fi­ca­tion. It al­so says it’s work­ing with the FDA to re­solve con­cerns — some­thing that the FDA ac­knowl­edged in its own re­lease.

The da­ta in ques­tion were meant to bol­ster the FDA’s un­der­stand­ing of the scope of pre­scrip­tion opi­oid use, the agency said, and were used to make rec­om­men­da­tions to the Drug En­force­ment Ad­min­is­tra­tion.

FDA sci­en­tists first no­ticed a dis­crep­an­cy with the re­port­ed amount of fen­tanyl sold, caus­ing IQVIA to over­es­ti­mate the to­tal amount of fen­tanyl dis­trib­uted in the mar­ket when ex­pressed in kilo­grams. Sub­se­quent dis­cus­sions and in­ves­ti­ga­tion re­vealed that the er­ror stems from IQVIA’s use of wrong weight-based con­ver­sion fac­tors. They al­so found prob­lems with da­ta for oxy­mor­phone and hy­drocodone.

“Hav­ing re­li­able and ac­cu­rate da­ta is es­sen­tial to the FDA’s mis­sion to pro­tect and pro­mote pub­lic health, and IQVIA is of­ten the sole source provider for cer­tain da­ta,” the FDA said be­fore in­tro­duc­ing Com­mis­sion­er Scott Got­tlieb’s di­rec­tions to the com­pa­ny.

Got­tlieb wants IQVIA to hire a third par­ty au­di­tor to as­sess all IQVIA prod­ucts that FDA uti­lizes and “pro­vide more trans­paren­cy on the meth­ods IQVIA us­es to gen­er­ate its da­ta.” Giv­en that IQVIA al­so serves da­ta to the DEA and oth­er HHS agen­cies, the FDA will al­so be work­ing with fed­er­al part­ners and — no­tably — “brief­ing mem­bers of Con­gress on IQVIA’s da­ta qual­i­ty is­sues and their po­ten­tial pub­lic health im­pli­ca­tions.”

The high pro­file lash­ing against one spe­cif­ic ven­dor on a tech­ni­cal is­sue was an un­usu­al move for the FDA, which tends to stick to trends. It does, how­ev­er, come at a time Con­gress is con­sid­er­ing a slate of opi­oid leg­is­la­tions, fu­eled by the in­tense pub­lic at­ten­tion to the opi­oid cri­sis, in which Got­tlieb has been giv­en a big role.

Even though this type of in­for­ma­tion was on­ly used nar­row­ly, the FDA said, it chose to share the in­for­ma­tion pub­licly “be­cause these da­ta have been used in fore­casts that have the po­ten­tial to im­pact on­go­ing work to fight the opi­oid epi­dem­ic.”

“We stand be­hind our da­ta method­olo­gies,” IQVIA stat­ed in its re­sponse. “We val­ue our long-stand­ing re­la­tion­ship with the FDA. We take the FDA’s con­cerns se­ri­ous­ly and will con­tin­ue work­ing with the FDA to re­solve these con­cerns to its sat­is­fac­tion.”

Im­age: FDA Com­mis­sion­er Scott Got­tlieb. GET­TY IM­AGES

Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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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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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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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.