At the end of Jan­u­ary, the Eu­ro­pean Med­i­cines Agency of­fi­cial­ly launched its new clin­i­cal tri­als in­fo sys­tem (CTIS), al­though the mi­gra­tion to the new plat­form has on­ly re­al­ly just be­gun, and spon­sors have un­til the end of Jan­u­ary 2023 be­fore all ini­tial tri­al ap­pli­ca­tions must be sub­mit­ted through CTIS.

Over­all, 56 clin­i­cal tri­al ap­pli­ca­tions have been sub­mit­ted in CTIS dur­ing the first 3 months since the launch of the sys­tem on Jan. 31, ac­cord­ing to new da­ta post­ed by the EMA. By com­par­i­son, about 4,000 new tri­als are au­tho­rized each year across Eu­rope.

As far as the num­ber of tri­als for which a de­ci­sion has been is­sued in CTIS by the EU mem­ber states is con­cerned, 4 non-com­mer­cial apps have re­ceived a de­ci­sion so far, and 0 com­mer­cial apps, al­though the vast ma­jor­i­ty of apps sub­mit­ted are still un­der re­view.

“Cur­rent­ly one multi­na­tion­al clin­i­cal tri­al has a de­ci­sion (au­tho­rised) in CTIS with 14 Mem­ber States Con­cerned,” the re­port notes. “An av­er­age will be pro­vid­ed in fu­ture re­ports when more than one multi­na­tion­al tri­al has a de­ci­sion record­ed.”

By Jan. 31, 2025, all on­go­ing tri­als ap­proved un­der the cur­rent EU tri­als di­rec­tive will be gov­erned by the new tri­als reg­u­la­tion, and have to be tran­si­tioned to the new CTIS.

Mean­while, to help tri­al spon­sors ful­fill their trans­paren­cy re­quire­ments un­der the new reg­u­la­tion, EMA said it is prepar­ing guid­ance on the pro­tec­tion of per­son­al da­ta and com­mer­cial­ly con­fi­den­tial in­for­ma­tion in CTIS.

And lat­er this sum­mer, EMA said it will host a CTIS-fo­cused event on lessons learned in the first six months from the CTIS launch.

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.