Eu­rope preps for the launch of its new clin­i­cal tri­als data­base, with a push to in­crease tri­al par­tic­i­pa­tion

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.

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.

FDA slams Eli Lil­ly's 'mis­lead­ing' In­sta­gram ad for its type 2 di­a­betes in­jec­tion

In a first for 2022, the FDA’s Office of Prescription Drug Promotion has issued an untitled letter, which was recently sent to Eli Lilly over what the agency calls a “misleading” and “particularly concerning” Instagram ad the company posted for its type 2 diabetes drug Trulicity.

The questionable Instagram post, which has since been deleted by Lilly, failed to adequately communicate the indication and limitations of use associated with Trulicity, FDA says.