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Endpoints Manufacturing

Manufacturing channel feed

Man­u­fac­tur­ing roundup: Gen­Script to boost pro­duc­tion ca­pac­i­ty; SK Bio­sciences inks MOU for its vac­cine in Thai­land

Last year

FDA rais­es clean­ing and qual­i­ty con­cerns at an­oth­er Ip­ca Lab­o­ra­to­ries man­u­fac­tur­ing site in In­dia

Last year
Pharma

Ther­mo Fish­er to ac­quire da­ta in­tel­li­gence com­pa­ny CorE­vi­tas for $900M+

Last year
Deals
Pharma

Q&A: Fu­ji­film Diosynth’s new CEO Lars Pe­tersen talks pri­or­i­ties and plans for the CD­MO

Last year
People

Te­va re­port­ed­ly con­sid­er­ing sale of API unit

Last year
Deals

Sanofi inks deal to help Sau­di Ara­bia man­u­fac­ture vac­cines lo­cal­ly

Last year
Deals

Pfiz­er, Sam­sung Bi­o­log­ics build on biosim­i­lar deals now worth $897M

Last year
Deals

CD­MO Adare Phar­ma So­lu­tions di­vests its post­bi­ot­ic di­vi­sion

Last year
Deals

FDA says Ip­ca Labs failed to ad­dress qual­i­ty is­sues with bad API batch­es

Last year
FDA+

Swedish man­u­fac­tur­er ac­quires Val­ne­va fa­cil­i­ty

Last year
Deals

FDA in­spec­tion at In­dia phar­ma at cen­ter of the cis­platin short­age cites mul­ti­ple qual­i­ty is­sues

Last year
R&D

Alvotech re­ceives an­oth­er CRL from the FDA for Hu­mi­ra biosim­i­lar can­di­date

Last year
Pharma
FDA+

Man­u­fac­tur­ing roundup: Finnish phar­ma Ori­on in­vest­ing $30M+ to boost pro­duc­tion; Biosyn­gen opens new Sin­ga­pore fa­cil­i­ty

Last year

Fu­ji­film Diosynth names Lars Pe­tersen to re­place Mar­tin Mee­son as CEO

Last year
People

FDA plots chal­lenges in im­ple­ment­ing new laws tar­get­ing phar­ma sup­ply chain

Last year
FDA+

Up­dat­ed: FDA re­jects high­er dose of Re­gen­eron's Eylea af­ter in­spec­tion at con­trac­tor Catal­ent

Last year
FDA+

A French start­up wants to de­cen­tral­ize cell and gene ther­a­py man­u­fac­tur­ing, mak­ing it 'the size of a book'

Last year
Financing
Cell/Gene Tx

API man­u­fac­tur­er in Chi­na hand­ed warn­ing let­ter af­ter fail­ing to re­spond to the reg­u­la­tor’s re­quests for in­for­ma­tion

Last year
FDA+

Emer­gent BioSo­lu­tions CEO Robert Kramer an­nounces re­tire­ment

Last year
People

Rep. Pal­lone push­es House Re­pub­li­cans to ad­dress drug short­ages in PAH­PA reau­tho­riza­tion

Last year
Pharma

Lon­za, Ver­tex to build a new cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty for the biotech’s type 1 di­a­betes ther­a­pies

Last year
Cell/Gene Tx

Sarep­ta's gene ther­a­py to be man­u­fac­tured at Catal­ent plant with 'op­er­a­tional chal­lenges' this spring

Last year
Cell/Gene Tx

Man­u­fac­tur­ing roundup: An­de­lyn Bio­sciences opens new fa­cil­i­ty in Ohio; No­vo warns of Ozem­pic coun­ter­feit

Last year

Ra­dioiso­tope man­u­fac­tur­er North­Star Med­ical Tech­nolo­gies names new CEO

Last year
People
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