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Endpoints Manufacturing

Manufacturing channel feed

New York Blood Cen­ter En­ter­pris­es buys Ta­laris’ cell ther­a­py fa­cil­i­ties in CD­MO ex­pan­sion

Last year

Bridge­Bio part­ners with bio­man­u­fac­tur­er Re­silience to pro­duce ear­ly-stage AAV gene ther­a­pies

Last year
R&D

FDA re­jects Gal­der­ma’s liq­uid neu­ro­tox­in due to CMC is­sues 

Last year
FDA+

FDA re­jects Eli Lil­ly’s eczema drug due to third-par­ty man­u­fac­tur­ing is­sues 

Last year
FDA+

FDA turns to Fre­se­nius im­ports from EU to help with com­mon can­cer drug short­age

Last year

BioN­Tech re­it­er­ates pres­ence in Africa; WuXi eyes first Chi­nese vac­cine plant; Chi­nese drug­mak­er blocks FDA checks

Last year

Blue­bird tweaks part­ner­ship with Lon­za to boost Zyn­te­glo, Skysona man­u­fac­tur­ing ca­pac­i­ty

Last year

Ex­clu­sive: CellFE rais­es $22M Se­ries A to ad­vance a new cell ther­a­py man­u­fac­tur­ing idea

Last year
Financing
Cell/Gene Tx

Pfiz­er restarts pro­duc­tion at tor­na­do-hit plant, ex­pects sup­ply is­sues to per­sist in­to 2024

Last year

Scynex­is pulls vagi­nal in­fec­tion tablet from shelves, paus­es on­go­ing tri­als on the heels of con­t­a­m­i­na­tion risk con­cerns

Last year

In­di­a's Glen­mark Phar­ma­ceu­ti­cals di­vests 75% stake in its API man­u­fac­tur­ing sub­sidiary

Last year
R&D

Q&A: No­vo Nordisk Foun­da­tion’s Celler­a­tor CEO Thomas Carlsen digs in­to $135.4M Dan­ish cell ther­a­py fa­cil­i­ty

Last year
Cell/Gene Tx

In new draft guid­ance for man­u­fac­tur­ing in­spec­tions, FDA draws in­spi­ra­tion from pan­dem­ic meth­ods

Last year
FDA+

Sam­sung Bi­o­log­ics locks $242M BMS deal; Fu­ture Fields launch­es CD­MO arm; SK pharmte­co takes con­trol of CBM

Last year

Up­dat­ed: So­ci­etal CD­MO lays off 26 em­ploy­ees, re­works hir­ing plans af­ter strat­e­gy re­view

Last year
People

Look­ing for an edge in a com­pet­i­tive mar­ket, Ox­ford Nanopore moves in­to mR­NA vac­cine test­ing

Last year
Outsourcing

No­vo Nordisk’s US semaglu­tide man­u­fac­tur­ing site un­der the spot­light again as 2022 mon­i­tor­ing is­sue sur­faces

Last year
Pharma

Mod­er­na de­creas­es mR­NA pro­duc­tion with Lon­za in Switzer­land, brings some man­u­fac­tur­ing in-house

Last year
Pharma

Ox­ford Bio­med­ica piv­ots by lay­ing off 200 peo­ple, ac­quir­ing ABL Eu­rope amid de­clin­ing to­tal rev­enues

Last year
People

NightHawk lays off 14% of R&D work­force, piv­ots to fo­cus on CD­MO Scor­pius Bio­man­u­fac­tur­ing

Last year
People

Ther­mo Fish­er is ready to ex­pand its vi­ral vec­tor pro­duc­tion site in Mass­a­chu­setts once there’s ‘de­mand for it’

Last year
Pharma

Chi­nese im­ports of com­mon can­cer drug run dry, FDA says

Last year
FDA+

Rentschler names Benedikt von Braun­muehl as CEO; Catal­ent grabs David McEr­lane from Lon­za as bi­o­log­ics lead

Last year
People

CDER di­rec­tor urges man­u­fac­tur­ers to work with FDA to fix in­spec­tion is­sues be­fore shut­ting down

Last year
Pharma
FDA+
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