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.

The FDA plans to re­duce the amount of da­ta re­quired to start a new drug tri­al in the US, cut­ting out most parts that aren’t safe­ty-re­lat­ed, FDA Com­mis­sion­er Mar­ty Makary told re­porters on Wednes­day.

The goal is to sim­pli­fy and ex­pe­dite the process of ap­ply­ing for an in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion, said Makary, who is en­ter­ing his sec­ond year lead­ing the FDA un­der the Trump ad­min­is­tra­tion. It’s a goal sup­port­ed by drug de­vel­op­ers, who have framed these re­forms as es­sen­tial to com­pet­ing against Chi­na's speedy clin­i­cal tri­al process.

“We are go­ing to re­duce the re­quire­ments of the IND ap­pli­ca­tion, re­mov­ing parts of the ap­pli­ca­tion that are not im­por­tant for safe­ty,” Makary said on the call. Ca­reer sci­en­tists at the agency will de­cide what parts aren’t nec­es­sary or could be re­viewed lat­er in the ap­proval process, he said.

Now Eli Lil­ly has an obe­si­ty pill, too.

On Wednes­day, the FDA ap­proved or­for­glipron, the agency an­nounced. It will be sold as Foun­dayo, and Lil­ly has pre­vi­ous­ly said it plans to sell a start­ing dose for $149 a month and high­er dos­es for up to $349 a month.

The ini­tial price ris­es to $349 for sub­se­quent dos­es if the pa­tient does not re­fill with­in a 45-day win­dow, a Lil­ly spokesper­son con­firmed to End­points News. If they do re­fill with­in that time, it would be a max­i­mum of $299 per month through the Foun­dayo self-pay pro­gram.

The pill was ap­proved un­der the FDA's new Com­mis­sion­er's Na­tion­al Pri­or­i­ty Vouch­er pro­gram, an ex­pe­dit­ed re­view path­way that sparked both promise and con­cern when it launched last year. The agency claimed that Foun­dayo was the fastest ap­proval of a new mol­e­c­u­lar en­ti­ty in more than two decades.

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.