Pres­i­dent Don­ald Trump is re­port­ed­ly set to im­ple­ment 100% phar­ma­ceu­ti­cal tar­iffs as soon as Thurs­day, but ac­cord­ing to a draft seen by End­points News, it ap­pears they would on­ly af­fect a small por­tion of drug­mak­ers.

The draft doc­u­ment lays out how Trump is plan­ning to im­ple­ment the tar­iffs on the phar­ma in­dus­try and how drug­mak­ers with “most fa­vored na­tion” deals with the White House will be ex­empt un­til 2029.

While the White House did not im­me­di­ate­ly re­spond to ques­tions from End­points, Bloomberg News re­port­ed some de­tails of the plan Wednes­day, in­clud­ing that they could be an­nounced as soon as to­day. The draft doc­u­ment could still be sub­ject to change be­fore the ad­min­is­tra­tion of­fi­cial­ly an­nounces it.

Last year's suc­cess­ful treat­ment of an in­fant known as Ba­by KJ en­cour­aged sci­en­tists to try again. But now, five weeks af­ter the FDA out­lined its plans to make such in­di­vid­u­al­ized ge­net­ic med­i­cines more ac­ces­si­ble, re­searchers are re­al­iz­ing how dif­fi­cult it will be to meet those new re­quire­ments.

“The door is open. It's just not very wide­ly open,” Ki­ran Musunuru, the gene edit­ing sci­en­tist at the Uni­ver­si­ty of Penn­syl­va­nia who co-led the cre­ation of Ba­by KJ’s ther­a­py, told End­points News in an in­ter­view.

The Ba­by KJ sto­ry has been tout­ed by US health of­fi­cials as a shin­ing ex­am­ple of the type of drug de­vel­op­ment they want to make eas­i­er and faster. But many times over the last year, the agency has pub­licly promised to dereg­u­late or cre­ate new path­ways, on­ly for com­pa­nies to run in­to road­blocks.

Near­ly all of In­cheon-head­quar­tered Sam­sung Bi­o­log­ic­s' union mem­bers have sup­port­ed plans to strike over wage ne­go­ti­a­tions, af­ter an in­ter­nal em­ploy­ee da­ta leak in No­vem­ber.

The Sam­sung Bi­o­log­ics La­bor Union said Mon­day that 95.52% of its mem­bers vot­ed in fa­vor of the strikes. The union group rep­re­sents about 75% of Sam­sung Bio’s rough­ly 5,000-per­son work­force. The la­bor ac­tion would be­gin in May un­less work­ers reach an agree­ment with the CD­MO be­fore then, ac­cord­ing to the union.

The work­er­s' con­cerns fol­low an in­ter­nal da­ta breach in No­vem­ber that caused per­son­al em­ploy­ee da­ta, in­clud­ing salaries and per­for­mance as­sess­ments, to be ac­ces­si­ble to any Sam­sung Bio work­er, ac­cord­ing to a re­port from Busi­ness Ko­rea. 

No­vo Nordisk is lay­ing off rough­ly 400 staffers at the Bloom­ing­ton, IN, fac­to­ry it re­cent­ly ac­quired, af­ter man­u­fac­tur­ing is­sues led the FDA to re­ject drugs from three sep­a­rate com­pa­nies that had con­tract­ed with the fa­cil­i­ty.

The job cuts will take place in May, and are most­ly man­u­fac­tur­ing po­si­tions, a No­vo spokesper­son told End­points News. Once com­plet­ed, the fa­cil­i­ty will em­ploy around 1,400 work­ers, the spokesper­son said.

The Dan­ish drug­mak­er told End­points it is re­duc­ing its head­count over "busi­ness re­al­i­ties" in a com­pet­i­tive mar­ket. “It's work that re­quires a fo­cused, right-sized team. We're align­ing our staffing ac­cord­ing­ly,” the spokesper­son said.

No­vo ac­quired the In­di­ana fac­to­ry in a deal with its par­ent en­ti­ty, No­vo Hold­ings, fol­low­ing the lat­ter’s $16.5 bil­lion pur­chase of the con­tract man­u­fac­tur­er Catal­ent. The trans­ac­tion was first an­nounced in Feb­ru­ary 2024.

The FDA has post­poned its dead­line on whether to ap­prove Or­ca Bio’s T cell ther­a­py by three months to Ju­ly 6.

The agency was ex­pect­ed to reach a ver­dict by April 6, but pushed back the de­ci­sion date af­ter the pri­vate com­pa­ny sub­mit­ted ad­di­tion­al da­ta around the man­u­fac­tur­ing of its cell ther­a­py. Known as Or­ca-T, it is de­signed to cut the risk of chron­ic graft-ver­sus-host dis­ease, a po­ten­tial se­ri­ous com­pli­ca­tion of stem cell trans­plants used for blood can­cer pa­tients.

“As part of that nor­mal re­view process, we had sub­mit­ted quite a bit of da­ta with re­gards to the CMC pack­age late in the re­view cy­cle, in the March time­frame, in re­sponse to some of the FDA ques­tions,” Or­ca Bio co­founder and CEO Nate Fern­hoff told End­points News.

The FDA fi­nal­ly green­lit No­vo Nordisk’s once-week­ly in­sulin for type 2 di­a­betes, mak­ing it the first US-ap­proved longer-act­ing al­ter­na­tive to dai­ly basal treat­ment for this in­di­ca­tion.

The Thurs­day ap­proval of the 700 units/ml basal in­jec­tion gives adults with type 2 di­a­betes a more con­ve­nient op­tion, re­duc­ing the num­ber of in­jec­tions need­ed from sev­en to one. It will be sold as Aw­iqli and will be avail­able to US pa­tients in the com­ing months.