The Biose­cure Act is slat­ed to be­come law af­ter the Sen­ate on Wednes­day passed a de­fense bill that in­cludes the mea­sure.

It's a de­vel­op­ment that once would have sent pan­ic through drug­mak­er board­rooms. But the leg­is­la­tion has since been weak­ened. Biose­cure would re­strict fed­er­al con­tracts with bio­phar­ma sup­pli­ers deemed for­eign ad­ver­saries, though un­like ear­li­er drafts, it stops short of nam­ing the ubiq­ui­tous con­trac­tors WuXi AppTec and WuXi Bi­o­log­ics.

Sens. Bill Hager­ty (R-TN) and Gary Pe­ters (D-MI) re­vived the leg­is­la­tion this sum­mer fol­low­ing in­flu­en­tial op­po­si­tion.

Last year, Rep. Jim Mc­Gov­ern (D-MA) and Sen. Rand Paul (R-KY) killed Biose­cure by ar­gu­ing it lacks due process for the WuXi en­ti­ties. That led to a com­pro­mise ver­sion that no longer names spe­cif­ic com­pa­nies. In­stead, the lat­est it­er­a­tion im­pos­es re­stric­tions on com­pa­nies that are on fed­er­al watch­lists. The Sen­ate vot­ed in Oc­to­ber to at­tach this new ver­sion to the an­nu­al de­fense pol­i­cy bill.

The Eu­ro­pean Com­mis­sion has un­veiled a long-await­ed pro­pos­al to make Eu­rope a "biotech pow­er­house” by speed­ing up clin­i­cal tri­als, ex­tend­ing in­tel­lec­tu­al prop­er­ty pro­tec­tion and boost­ing bio­man­u­fac­tur­ing.

The com­mis­sion pub­lished the first half of the EU Biotech Act Tues­day and sent it to the Eu­ro­pean Par­lia­ment to adopt. The pro­pos­al comes just a week af­ter EU reg­u­la­tors said they’d agreed on a ma­jor leg­isla­tive pack­age al­so aim­ing to im­prove the phar­ma sec­tor.

Cur­rent­ly, Eu­rope is falling be­hind its com­peti­tors, the com­mis­sion said Tues­day. Be­tween 2015 and June 2025, the EU pulled in 7% of glob­al health biotech ven­ture cap­i­tal fund­ing, com­pared to the 63% in­vest­ed in­to the US.

The FDA wants No­vo Nordisk to an­a­lyze all sites it bought from Catal­ent last year, ac­cord­ing to a warn­ing let­ter the agency sent to the drug­mak­er over its trou­bled fac­to­ry in Bloom­ing­ton, IN.

The warn­ing let­ter, dat­ed Nov. 20 and pub­lished this month, out­lines sev­er­al is­sues at the Bloom­ing­ton fa­cil­i­ty, in­clud­ing over 20 cas­es of “mam­malian hair” in­spec­tors found in or around drug prod­uct vials.

While the is­sues start­ed be­fore No­vo ac­quired the fa­cil­i­ty from Catal­ent in De­cem­ber 2024, the prob­lems con­tin­ued “well af­ter” the deal closed, the agency said in the let­ter.

The FDA rec­om­mend­ed that No­vo look at the “qual­i­ty as­sur­ance over­sight struc­tures” at the oth­er two sites it bought from Catal­ent, one in Italy and the oth­er in Bel­gium.

Mod­er­na has snagged a new part­ner to help pay for a Phase 3 study of its H5 pan­dem­ic in­fluen­za vac­cine, more than six months af­ter the US axed fund­ing for the project.

The Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions will in­vest up to $54.3 mil­lion to fi­nance the study, slat­ed to be­gin in ear­ly 2026, Mod­er­na said Thurs­day. The piv­otal tri­al will test the safe­ty and im­muno­genic­i­ty of mR­NA-1018 and will be run in the UK and US.

CEPI is fill­ing a fi­nan­cial void left by the US gov­ern­ment, which ter­mi­nat­ed a con­tract with Mod­er­na ear­li­er this year to help fund the tri­al; the axed deal gave the US rights to pur­chase sup­ply of the shot.

Em­pow­er Phar­ma­cy, a large GLP-1 com­pound­ing phar­ma­cy that’s faced al­le­ga­tions of poor qual­i­ty drugs and a le­gal chal­lenge from Eli Lil­ly, has stopped op­er­a­tions at its New Jer­sey man­u­fac­tur­ing fa­cil­i­ty and laid off hun­dreds of em­ploy­ees, End­points News has learned.

The com­pa­ny, head­quar­tered in Hous­ton, ex­pand­ed its op­er­a­tions to New Jer­sey with the ac­qui­si­tion of a 17,000-square-foot out­sourc­ing fa­cil­i­ty in East Wind­sor in 2024. An Em­pow­er news re­lease at the time said the site would be ca­pa­ble of pro­duc­ing 50 mil­lion vials of drugs, worth about $1.5 bil­lion in rev­enue, per year.

But this month, the com­pa­ny moved to stop op­er­a­tions at the out­sourc­ing fa­cil­i­ty and cut all of its staff, mul­ti­ple peo­ple fa­mil­iar with the mat­ter told End­points. Lay­offs al­so af­fect­ed work­ers in Hous­ton, said the peo­ple. A to­tal of 285 work­ers were in­clud­ed in the cuts, ac­cord­ing to a sep­a­ra­tion agree­ment re­viewed by End­points.

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

Al­ny­lam Phar­ma­ceu­ti­cals is spend­ing $250 mil­lion to ex­pand its fac­to­ry in Nor­ton, MA. The in­vest­ment will in­crease the site's ca­pac­i­ty for siR­NA en­zy­mat­ic-lig­a­tion man­u­fac­tur­ing. The FDA has al­so ac­cept­ed Al­ny­lam’s en­zyme man­u­fac­tur­ing plat­form called siRELIS in­to its Emerg­ing Tech­nol­o­gy Pro­gram.

INCOG Bio­Phar­ma Ser­vices is in­vest­ing $200 mil­lion to ex­pand ca­pac­i­ty for in­jecta­bles at its fac­to­ry in Fish­ers, IN. The ex­pan­sion will start ear­ly next year, and the site will em­ploy al­most 1,000 work­ers by 2030.

No­var­tis has bro­ken ground on an ex­pan­sion in North Car­oli­na as part of its $23 bil­lion pledge to the US, ac­cord­ing to a Fri­day re­lease. No­var­tis will con­struct a fac­to­ry in Mor­risville, two new fa­cil­i­ties in Durham, and add to an ex­ist­ing fac­to­ry in Durham, cre­at­ing 700 jobs by 2030.

Em­ber Life­Sciences raised $16.5 mil­lion in a Se­ries A fund­ing round that will help the ship­ping and lo­gis­tics com­pa­ny make progress on its prod­uct pipeline, in­clud­ing the Em­ber Cube 2 ship­ping box. Sea Court Cap­i­tal led the fund­ing, with par­tic­i­pants in­clud­ing Car­di­nal Health and Car­ri­er Ven­tures.