At the end of this month, the Eu­ro­pean Med­i­cines Agency will roll out its new, long-await­ed Clin­i­cal Tri­als In­for­ma­tion Sys­tem, a one-stop-shop for all clin­i­cal tri­al doc­u­men­ta­tion in the EU that will al­so sup­port the spon­sors and reg­u­la­tors through­out the tri­als.

Once it’s live, CTIS will of­fer a sin­gle clin­i­cal tri­al ap­pli­ca­tion dossier, cov­er­ing clin­i­cal tri­al ap­pli­ca­tions sub­mit­ted to EU/EEA mem­ber states (and to Na­tion­al Com­pe­tent Au­thor­i­ties and ethics com­mit­tees) and reg­is­tra­tion of the tri­al, all in one in­te­grat­ed sub­mis­sion.

The launch is the cul­mi­na­tion of the adop­tion of the Clin­i­cal Tri­al Reg­u­la­tion, which en­tered in­to force back in 2014. But its ap­pli­ca­tion was de­pen­dent on the full func­tion­al­i­ty of CTIS, fol­low­ing an in­de­pen­dent au­dit that was com­plet­ed last April.

Lin­da Bowen, glob­al head of reg­u­la­to­ry pol­i­cy and in­tel­li­gence at Seagen, told End­points News that the CTIS is vol­un­tary for the time be­ing and most com­pa­nies will like­ly start with one or two sub­mis­sions in 2022.

“EMA has done a great job in pro­vid­ing train­ing, es­pe­cial­ly for the mas­ter train­ers. We will just have to see how it re­al­ly works. My gut feel­ing is that spon­sors will start slow­ly,” she said.

CTIS will al­so of­fer the gen­er­al pub­lic and re­searchers a search­able clin­i­cal tri­al data­base, with re­sults avail­able both as a tech­ni­cal sum­ma­ry and in lay lan­guage, ac­cord­ing to the EMA.

The launch of the new CTIS, which the EMA clar­i­fies is not meant to re­place a clin­i­cal tri­al man­age­ment sys­tem for spon­sors, comes as about 40% of tri­als in Eu­rope are spon­sored by acad­e­mia. Those are of­ten small and on­ly con­duct­ed in a sin­gle coun­try. The oth­er 60% of tri­als are spon­sored by the phar­ma in­dus­try.

The EMA not­ed “a re­cent shift to more aca­d­e­m­ic tri­als be­ing done dur­ing the COVID-19 pan­dem­ic,” adding that both acad­e­mia and phar­ma spon­sors “need greater sup­port and en­able­ment for Eu­rope to flour­ish as a glob­al fo­cus for clin­i­cal re­search, both in the de­vel­op­ment of new med­i­cines and in the re­fine­ment of use of ex­ist­ing med­i­cines.”

As part of this push for more tri­als and tri­al par­tic­i­pa­tion in Eu­rope, the reg­u­la­tors this week es­tab­lished a new ini­tia­tive, known as the Ac­cel­er­at­ing Clin­i­cal Tri­als in the EU (ACT EU), which lists among its ob­jec­tives the need to sup­port more large-scale multi­na­tion­al tri­als “with broad­er ge­o­graph­i­cal scope,” as well as “re­duc­ing ad­min­is­tra­tive bur­den and in­creas­ing ef­fi­cien­cy.”

Among its plans, ACT EU wants to de­vel­op key per­for­mance in­di­ca­tors and a dash­board to track the per­for­mance of the Eu­ro­pean clin­i­cal tri­als en­vi­ron­ment.

ACT EU, which is run by the EMA, the Heads of Med­i­cines Agen­cies and the Eu­ro­pean Com­mis­sion, al­so plans to de­vel­op and pub­lish key method­olo­gies guid­ance, in­clud­ing on the im­pact of AI and ma­chine learn­ing on clin­i­cal tri­als, com­plex tri­als, de­cen­tral­ized tri­als and more, as part of its work to “strength­en links be­tween in­no­va­tion and sci­en­tif­ic ad­vice fo­ra.”

And by lever­ag­ing the var­i­ous aca­d­e­m­ic, non-prof­it, Eu­ro­pean and in­ter­na­tion­al ini­tia­tives around tri­als, they’re al­so look­ing to im­prove the way re­search is fund­ed with ev­i­dence-based de­ci­sion mak­ing.

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.