An an­nu­al re­port to Con­gress on Chi­na’s glob­al reach says the US is over­re­liant on Chi­na’s pro­duc­tion of ac­tive phar­ma­ceu­ti­cal in­gre­di­ents, pos­ing a na­tion­al se­cu­ri­ty con­cern to the phar­ma sup­ply chain.

The US-Chi­na Eco­nom­ic and Se­cu­ri­ty Re­view Com­mis­sion’s re­port rec­om­mends that Con­gress “build U.S. phar­ma­ceu­ti­cal sup­ply chain re­silience.” The vast ma­jor­i­ty of all drugs used in the US are gener­ics, but near­ly a quar­ter of their in­gre­di­ents are “po­ten­tial­ly” sourced from Chi­na, the re­port found.

The prob­lem is worse for oral gener­ic pills. The US man­u­fac­tures less than a quar­ter of its oral gener­ics and in­stead re­lies heav­i­ly on In­dia and Chi­na.

"The Unit­ed States cur­rent­ly faces a fu­ture in which it de­pends on Chi­na for ac­cess to the most cut­ting-edge biotech­nol­o­gy in­no­va­tions, so­phis­ti­cat­ed bio­man­u­fac­tur­ing equip­ment, and ad­vanced bio­ma­te­ri­als," a sum­ma­ry of the re­port says.

Tar­iffs on brand­ed phar­ma­ceu­ti­cal prod­ucts from Switzer­land and Liecht­en­stein will be capped at 15% un­der a new trade deal with the US, the White House an­nounced.

The US will ap­ply whichev­er is high­est out of the "most fa­vored na­tion" (MFN) tar­iff rate or a 15% tax on goods orig­i­nat­ing from the two coun­tries, the Trump ad­min­is­tra­tion said on Fri­day. These levies will not ex­ceed 15% for any prod­ucts that are sub­ject to fu­ture phar­ma tar­iffs aris­ing from the De­part­ment of Com­merce's Sec­tion 232 in­ves­ti­ga­tion.

This lat­est deal mir­rors the de­tails of the US-EU deal an­nounced in Ju­ly and re­flects the Trump ad­min­is­tra­tion's goal of boost­ing drug man­u­fac­tur­ing in the US, with over $480 bil­lion pledged to the coun­try so far this year.

Schol­ar Rock said it in­tends to launch its spinal mus­cu­lar at­ro­phy drug apite­gromab next year, even af­ter the FDA re­ject­ed the drug over is­sues it found at a man­u­fac­tur­ing site run by No­vo Nordisk.

An­a­lysts ex­pect­ed Schol­ar Rock would have to launch apite­gromab in 2027, af­ter the com­pa­ny re­ceived a com­plete re­sponse let­ter in Sep­tem­ber. Schol­ar Rock’s stock SRRK was up near­ly 26% on Fri­day, but is now down about 2% as of Mon­day morn­ing.

Schol­ar Rock was the sec­ond com­pa­ny to re­ceive a CRL due to is­sues at No­vo’s site in Bloom­ing­ton, IN, which com­pletes fill-fin­ish for apite­gromab. Catal­ent for­mer­ly ran the site.

The FDA has OK'd Re­gen­eron’s Eylea HD in­jec­tion for an­oth­er in­di­ca­tion and as a month­ly dos­ing op­tion, de­spite is­sues at its third-par­ty man­u­fac­tur­ing site run by No­vo Nordisk.

Re­gen­eron se­cured ap­provals for Eylea HD in pa­tients with mac­u­lar ede­ma af­ter a reti­nal vein oc­clu­sion (RVO), in­ject­ing it every eight weeks af­ter ini­tial month­ly dos­ing, ac­cord­ing to a Wednes­day re­lease. Mac­u­lar ede­ma oc­curs when a part of the reti­na swells, lead­ing to blurred or lost vi­sion.

The reg­u­la­tor al­so ap­proved a month­ly dos­ing op­tion of Eylea HD for all ap­proved in­di­ca­tions, in­clud­ing as a treat­ment for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion, di­a­bet­ic mac­u­lar ede­ma, di­a­bet­ic retinopa­thy and RVO.

The FDA and gener­ic drug­mak­ers kicked off closed-door ne­go­ti­a­tions late last month over the fourth round of user fees, with the agency of­fer­ing up its wish list of changes it wants to see from in­dus­try.

Meet­ing at the FDA's White Oak, MD cam­pus on Oct. 22, the FDA told in­dus­try rep­re­sen­ta­tives that it wants to help ad­dress the oc­cur­rence of "da­ta fi­deli­ty is­sues," ac­cord­ing to meet­ing min­utes the agency post­ed on Thurs­day. Da­ta in­tegri­ty has been a ma­jor fo­cus for the agency as it says it will look to im­prove trans­paren­cy around man­u­fac­tur­ing fa­cil­i­ty and con­tract re­search or­ga­ni­za­tion (CRO) da­ta.

Wel­come to End­points News’ man­u­fac­tur­ing briefs, where we bring you es­sen­tial news on new builds, col­lab­o­ra­tions, re­calls and more.

Some phar­ma com­pa­nies are start­ing to add de­tail to their US man­u­fac­tur­ing pledges, af­ter over $480 bil­lion has al­ready been com­mit­ted to the coun­try since the start of the year. Mean­while, oth­er com­pa­nies are an­nounc­ing new pledges to the US.

And drug­mak­ers are rush­ing to on­shore US man­u­fac­tur­ing as Pres­i­dent Don­ald Trump con­tin­ues to threat­en phar­ma-spe­cif­ic tar­iffs, de­spite no fur­ther de­tails on the De­part­ment of Com­merce’s 232 in­ves­ti­ga­tion in­to the sec­tor.

• Re­gen­eron Phar­ma­ceu­ti­cals is in­vest­ing $2 bil­lion for a new fa­cil­i­ty in Sarato­ga Springs, NY, which will cre­ate 1,000 new jobs, ac­cord­ing to a Nov. 13 press re­lease.
• CSL has bud­get­ed about $1.5 bil­lion to ex­pand its foot­print in the US over the next five years for its phar­ma-de­rived as­sets. In a Tues­day re­lease, CEO and man­ag­ing di­rec­tor Paul McKen­zie not­ed that the US is “the world’s lead­ing source of plas­ma.” The com­pa­ny says the move will lead to “hun­dreds” of jobs and bol­ster its US sup­ply chain. In Au­gust, CSL an­nounced sweep­ing changes to its op­er­a­tions, which in­clud­ed lay­offs and clos­ing 22 “un­der­per­form­ing” plas­ma cen­ters.
• Cell­tri­on will in­vest up to $478 mil­lion to ex­pand its US fa­cil­i­ty in re­sponse to tar­iffs, the com­pa­ny said Tues­day. The South Ko­re­an CD­MO al­so re­cent­ly bought a fac­to­ry in Branch­burg, NJ, from Eli Lil­ly for $330 mil­lion in Sep­tem­ber.
• Mod­er­na is in­vest­ing $140 mil­lion to ex­pand its Nor­wood, MA, site to in­clude the fi­nal stages of mR­NA man­u­fac­tur­ing, the com­pa­ny said W