Months af­ter a slate of phar­ma com­pa­nies slammed the brakes on some op­er­a­tions in both Rus­sia and Ukraine, No­var­tis an­nounced that it’s re­sum­ing busi­ness re­mote­ly in Ukraine “to help the war-torn coun­try re­store some ba­sic crit­i­cal busi­ness process­es.”

No­var­tis came to the de­ci­sion af­ter study­ing safe­ty pro­to­cols and re­ceiv­ing ad­vice “which we will reg­u­lar­ly re­view,” the com­pa­ny said on Wednes­day.

“The safe­ty and se­cu­ri­ty of our peo­ple re­mains our num­ber one ob­jec­tive, and we will con­stant­ly re­view the sit­u­a­tion and our busi­ness op­er­a­tions in Ukraine,” the com­pa­ny said in a state­ment.

The phar­ma gi­ant once again con­demned the war, which has trig­gered Eu­rope’s largest refugee cri­sis since World War II and tak­en more than 4,000 civil­ian lives, ac­cord­ing to the UN.

No­var­tis joined sev­er­al Big Phar­ma com­pa­nies in tak­ing ac­tion against Rus­sia back in March, sus­pend­ing cap­i­tal in­vest­ments, me­dia ad­ver­tis­ing and oth­er pro­mo­tion­al ac­tiv­i­ties in the coun­try. And while it promised to con­tin­ue sup­ply­ing med­i­cine to Rus­sia, it paused the ini­ti­a­tion of new clin­i­cal tri­als and the en­roll­ment of new par­tic­i­pants in ex­ist­ing tri­als.

At the time, J&J, GSK, Mer­ck, Bris­tol My­ers Squibb and Roche had al­ready put new site ac­ti­va­tion and new pa­tient en­roll­ment on hold in Rus­sia. A hand­ful of com­pa­nies — in­clud­ing Mer­ck, As­traZeneca, GSK, Bris­tol My­ers Squibb, Pfiz­er and oth­ers — al­so sus­pend­ed en­roll­ment in some Ukraine tri­als.

Back in March, clin­i­cal­tri­als.gov list­ed more than 600 on­go­ing tri­als in var­i­ous re­cruit­ing stages with at least one study site in Ukraine. In April, the EMA is­sued new guid­ance de­signed to help spon­sors of on­go­ing stud­ies nav­i­gate dis­rup­tions that are ex­pect­ed to con­tin­ue.

Over the last few months, No­var­tis has de­liv­ered more than 1.3 mil­lion packs of an­tibi­otics, painkillers, and car­dio­vas­cu­lar and on­col­o­gy treat­ments — worth more than $33 mil­lion — to Ukraine and its refugees in bor­der coun­tries. The com­pa­ny has al­so do­nat­ed $3 mil­lion to char­i­ties sup­port­ing refugees and is giv­ing an­oth­er $1 mil­lion to pa­tient or­ga­ni­za­tions, which help pa­tients get treat­ment abroad, trans­late med­ical re­ports, and dis­sem­i­nate knowl­edge of hos­pi­tals ready to ad­mit pa­tients.

“Our team in Ukraine is ea­ger to come back to their work, and to play their part in main­tain­ing our pri­or­i­ty to en­sure that those in need of life-chang­ing med­i­cines gain the best pos­si­ble sup­port from No­var­tis and San­doz,” No­var­tis said.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.