Large phar­ma com­pa­nies that have made “most fa­vored na­tion” deals with the White House will have un­til the end of Pres­i­dent Don­ald Trump’s cur­rent term to ful­fill some of their com­mit­ments to in­vest in the US, ac­cord­ing to a frame­work of the agree­ments re­viewed by End­points News.  

The doc­u­ment, ti­tled a “let­ter of agree­ment,” is a tem­plate that ap­pears to for­mal­ize agree­ments be­tween com­pa­nies and the US De­part­ment of Com­merce. Its au­then­tic­i­ty was con­firmed by mul­ti­ple sources in­volved in those ne­go­ti­a­tions.

The ex­act amounts com­pa­nies will have to in­vest in the US are be­ing ne­go­ti­at­ed in­di­vid­u­al­ly, ac­cord­ing to two drug­mak­ers in­volved in talks. At least one ex­pects to ful­fill the en­tire­ty of its multi­bil­lion-dol­lar pledge by the Jan. 1, 2029 dead­line.

WuXi AppTec’s re­prieve from a Wash­ing­ton crack­down may not last.

The Pen­ta­gon is re­port­ed­ly seek­ing to add WuXi AppTec to a list of com­pa­nies that aid the Chi­nese mil­i­tary. Such a des­ig­na­tion would height­en scruti­ny of the com­pa­ny, and once again make it a tar­get of the pro­posed Biose­cure Act that seeks to re­strict cer­tain Chi­nese bio­phar­ma con­trac­tors.

A let­ter sent Oct. 7 by Deputy De­fense Sec­re­tary Stephen Fein­berg to the heads of con­gres­sion­al de­fense com­mit­tees rec­om­mend­ed adding eight com­pa­nies, in­clud­ing WuXi AppTec, to the Pen­ta­gon’s so-called 1260H list, Bloomberg News re­port­ed. It’s un­clear why Fein­berg rec­om­mend­ed WuXi AppTec for the list, and the Pen­ta­gon did not re­spond to a re­quest for com­ment.

The UK gov­ern­ment on Mon­day an­nounced a ma­jor drug pric­ing deal with the White House in which the UK will pay bil­lions more pounds for med­i­cines in ex­change for a re­prieve from phar­ma tar­iffs on US-bound ex­ports for three years.

Ne­go­ti­a­tions on the UK-US trade deal have been on­go­ing since at least Oc­to­ber. US trade en­voy Jamieson Greer was in Lon­don on Nov. 24 to fi­nal­ize the terms of the deal.

As part of the arrange­ment, the UK gov­ern­ment will raise its cost-ef­fec­tive­ness thresh­old for new drugs by 25%. That thresh­old de­ter­mines whether the UK’s Na­tion­al In­sti­tute for Health and Care Ex­cel­lence (NICE) will rec­om­mend a new drug to the NHS, and has been un­changed for two decades. In essence, NICE will be able to rec­om­mend more drugs that would have been pre­vi­ous­ly re­ject­ed be­cause they were be­lieved to be too ex­pen­sive.

A New York start­up that's look­ing to ac­cel­er­ate how quick­ly pre­clin­i­cal small mol­e­cule can­di­dates en­ter clin­i­cal tri­als has cor­ralled $95 mil­lion.

Ex­cel­sior Sci­ences has raised $70 mil­lion in a Se­ries A round, led by Deer­field Man­age­ment, Khosla Ven­tures and Sofinno­va Part­ners, with Eli Lil­ly and oth­ers pitch­ing in. The start­up al­so se­cured a $25 mil­lion grant from New York’s Em­pire State De­vel­op­ment, which sup­ports lo­cal busi­ness­es, the com­pa­ny said Wednes­day. The start­up is op­er­at­ing from a 1,500-square-foot lab­o­ra­to­ry on Park Av­enue.

The Se­ries A will be used in part to de­vel­op its chem­i­cal syn­the­sis tech­nol­o­gy, co-founder and chief op­er­at­ing of­fi­cer Jana Jensen told End­points News in an in­ter­view. It will al­so use the raise to de­vel­op its own pipeline of small mol­e­cules, she added.

Im­vax, a biotech led by for­mer Spark Ther­a­peu­tics ex­ec­u­tives, says its glioblas­toma treat­ment was suc­cess­ful at keep­ing pa­tients alive about six months longer than stan­dard of care in a Phase 2b study. But the ex­per­i­men­tal ap­proach did not suc­ceed on the pri­ma­ry end­point of pro­gres­sion-free sur­vival.

The Philadel­phia start­up is forg­ing ahead, though. It be­lieves over­all sur­vival is the agen­cy's de­sired reg­u­la­to­ry end­point, and there's a "pauci­ty of op­tions for pa­tients over the last 20 years and no re­al im­prove­ment in stan­dard of care,” ex­ec­u­tive chair John Furey told End­points News.

The five-year sur­vival rate is about 7%, ac­cord­ing to the Glioblas­toma Foun­da­tion.

No­var­tis plans to re­or­ga­nize two Swiss fa­cil­i­ties, which it says could re­sult in 550 lay­offs as it dis­con­tin­ues some man­u­fac­tur­ing at its site in Stein.

The com­pa­ny in­tends to dis­con­tin­ue tablet and cap­sule man­u­fac­tur­ing and pack­ag­ing at the fa­cil­i­ty by the end of 2027, it said Tues­day in a re­lease. The po­ten­tial job cuts could oc­cur by the end of 2027, but that could change de­pend­ing on a con­sul­ta­tion process, No­var­tis said.

The Stein fac­to­ry will con­tin­ue to fo­cus on cell and gene ther­a­py man­u­fac­tur­ing, with No­var­tis plan­ning to in­vest $26 mil­lion at the site to boost ster­ile dosage form ca­pac­i­ty.

Mean­while, the drug­mak­er is al­so plan­ning to in­vest $80 mil­lion at its Schweiz­er­halle fa­cil­i­ty to ex­pand small in­ter­fer­ing RNA pro­duc­tion for its car­dio­vas­cu­lar, re­nal and meta­bol­ic ther­a­pies. The Schweiz­er­halle ex­pan­sion will cre­ate 80 new jobs.