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Endpoints Manufacturing

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'Pull every lev­er': Marks dou­bles down on ur­gency to im­prove gene ther­a­py man­u­fac­tur­ing

Last year
Pharma
Cell/Gene Tx

Up­dat­ed: Cel­lares to pro­duce Ca­balet­ta’s au­toim­mune CAR-T can­di­date 

Last year
Deals

House Over­sight Com­mit­tee opens probe in­to FDA's han­dling of drug short­ages

Last year
FDA+

FDA hands In­di­a's Nat­co Phar­ma an­oth­er 483, with eight ob­ser­va­tions cit­ed 

Last year
FDA+

Pfiz­er to cut 200 jobs at Michi­gan plant that makes Covid prod­ucts

Last year
People
R&D

No­var­tis’ Plu­vic­to sup­ply ‘ful­ly un­con­strained,’ eyes man­u­fac­tur­ing ex­pan­sion

Last year

FDA par­tial­ly halts Nurix Ther­a­peu­tics’ can­cer tri­al as it im­proves man­u­fac­tur­ing process

Last year
Pharma
FDA+

Dai­ichi Sankyo to boost ADC man­u­fac­tur­ing; Eli Lil­ly looks to out­er space; new FDA ini­tia­tive for man­u­fac­tur­ing tech

Last year

Ra­dio­phar­ma CD­MOs nav­i­gate sup­ply chain, raw ma­te­r­i­al chal­lenges as de­mand goes nu­clear

Last year
In Focus

Mod­er­na cuts back on man­u­fac­tur­ing; Lil­ly eyes Moun­jaro sup­ply boost; GSK’s shin­gles vac­cine ‘un­con­strained’

Last year

No­vo Nordisk is still play­ing catch up as We­govy de­mand rock­ets up­ward

Last year
Pharma

Vi­ro­Cell to op­er­ate from a Lon­don fa­cil­i­ty to man­u­fac­ture vi­ral vec­tors for clin­i­cal tri­als

Last year

As In­dia grows its bi­o­log­ics mar­ket, Ara­gen builds new $30M fa­cil­i­ty

Last year

Catal­en­t's stock down af­ter Sarep­ta’s PhI­II Duchenne study miss­es pri­ma­ry end­point

Last year

Oph­thalmic drugs face FDA is­sues again, one man­u­fac­tur­er re­spon­si­ble for 26 con­t­a­m­i­nat­ed prod­ucts

Last year
FDA+

Pfiz­er clos­es sites in New Jer­sey, North Car­oli­na as it ex­e­cutes plan for $3.5B in cost cuts

Last year
Pharma

WuXi AppTec slash­es 2023 growth rev­enue fore­cast in half due to drop in de­mand for ear­ly-stage ser­vices

Last year

Mer­ck to boost Gar­dasil pro­duc­tion; In­creased de­mand for Sanofi’s RSV drug; Take­da ad­dress­es fa­cil­i­ty ‘im­pair­ment’ 

Last year

Heard at #CPHI: VC fund­ing trends; Sam­sung eyes ex­pan­sion; and sup­ply chain di­ver­si­fi­ca­tion

Last year

WuXi TIDES boosts oli­go, pep­tide of­fer­ings due to a rise in de­mand, with new builds on­go­ing

Last year

Eu­ro­pean Com­mis­sion out­lines how coun­tries can share drugs to mit­i­gate short­ages

Last year
FDA+

Eu­roAPI CEO steps down; Sam­sung Bi­o­log­ics looks to Eu­rope; Mer­ck re­calls pneu­mo­coc­cal vac­cines

Last year

Ther­mo Fish­er grows in­to CGT man­u­fac­tur­ing, while Sam­sung Bi­o­log­ics ex­pands in­to AD­Cs

Last year
Cell/Gene Tx

Re­mote FDA drug in­spec­tions: New draft guid­ance spells out post-pan­dem­ic specifics

Last year
FDA+
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