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Endpoints Manufacturing

Manufacturing channel feed

Sanofi and As­traZeneca to make 230,000 ad­di­tion­al RSV im­mu­niza­tions avail­able, White House says

Last year
Pharma
FDA+

NightHawk be­comes pure-play CD­MO; Lon­za to make liv­er can­cer drug; BioN­Tech gears up to open first site in Africa

Last year

No­vo Nordisk to boost oral GLP-1 man­u­fac­tur­ing via $92.5M buy for Alk­er­mes’ Ire­land fa­cil­i­ty

Last year
Deals

FDA puts three CARs­gen CAR-T ther­a­pies on clin­i­cal hold, in­clud­ing Mod­er­na-part­nered pro­gram

Last year
Cell/Gene Tx
FDA+

MIT spin­out aims to im­prove man­u­fac­tur­ing of pep­tides 

Last year

Sanofi’s Mourenx pro­duc­tion site leaked a po­ten­tial­ly can­cer­ous neu­ro­tox­in for the sec­ond time 

Last year
Pharma

UMass med­ical school’s man­u­fac­tur­ing busi­ness trims 36 po­si­tions

Last year
People

Over 200 crit­i­cal med­i­cines to be mon­i­tored for short­ages in the EU 

Last year

FDA rolls out new draft guid­ance on ad­vanced man­u­fac­tur­ing tech

Last year
Pharma
FDA+

Re­silience plans to ex­pand Ohio fa­cil­i­ty with 440 new jobs over three years

Last year

Catal­ent de­tails rev­enue down­turn, staff cuts as it looks for­ward to a brighter 2024

Last year

Gavi an­nounces $1.8B for vac­cine ac­cess, pan­dem­ic pre­pared­ness ef­forts in Africa

Last year
R&D
Pharma

Synaf­fix ex­pands In­novent deal; Re­ci­pharm co-de­vel­ops in­halers; Vit­riVax gets $5M for vac­cine tech

Last year

Cel­lec­tis shifts CAR-T man­u­fac­tur­ing in-house, boosts ef­fi­ca­cy com­pared to third-par­ty CD­MOs: #ASH23 

Last year
Cell/Gene Tx

ADC man­u­fac­tur­ing will like­ly stay with es­tab­lished CD­MOs due to high bar­ri­er to mar­ket en­try

Last year

FDA sends let­ter to No­var­tis over Kym­ri­ah man­u­fac­tur­ing safe­ty con­cerns

Last year
Pharma
FDA+

Fu­ji­film makes $200M man­u­fac­tur­ing in­vest­ment while No­var­tis pours $80M+ in­to Chi­na fa­cil­i­ty

Last year
Pharma

WuXi Bi­o­log­ics’ stock slides 24% as man­u­fac­tur­ing busi­ness slows amid biotech down­turn

Last year

FDA ships Form 483 to gener­ic drug gi­ant Dr. Red­dy’s due to equip­ment is­sues, oth­er ob­ser­va­tions

Last year
Pharma
FDA+

2024 VC fore­cast: Clin­i­cal-stage CD­MOs like­ly to have uptick in de­mand but spe­cial­iza­tion crit­i­cal

Last year

Charles Riv­er works on rare dis­ease gene ther­a­py; Emer­gent gets $75M for an­thrax vac­cine; Eu­roAPI hires new COO 

Last year

Cell man­u­fac­tur­ing com­pa­ny rais­es $19M Se­ries A to in­crease ca­pac­i­ty, staff num­bers 

Last year
Financing

In­tas Phar­ma­ceu­ti­cal­s' In­di­an fa­cil­i­ty hit with FDA warn­ing let­ter, placed on im­port alert

Last year
FDA+

Am­gen teams up with Ama­zon on AI plat­form to en­hance new Ohio man­u­fac­tur­ing site

Last year
AI
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