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.

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Two and a half years after setting out on another foray into oncology R&D, a biotech headed by David Hung — of Medivation fame — has run into its first setback.

San Francisco-based Nuvation Bio announced early Monday the FDA placed a partial clinical hold on a Phase I dose-escalation study of NUV-422, its CDK inhibitor program for certain types of solid tumors. The trial began enrolling patients in December 2020, and, according to Nuvation, researchers were in the middle of exploring dose escalation and defining the maximum dose tolerable in patients.