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Endpoints Manufacturing

Manufacturing channel feed

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

2 years ago
People

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

3 years ago
Pharma

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

3 years ago
Cell/Gene Tx

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

3 years ago
Cell/Gene Tx

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

3 years ago

Ra­dioiso­tope man­u­fac­tur­er North­Star Med­ical Tech­nolo­gies names new CEO

3 years ago
People

Brook­ings of­fers ideas on how to im­prove short­ages of ster­ile in­jecta­bles

3 years ago
Pharma

Sau­di Ara­bia looks to boost bio­phar­ma in­ter­est with new con­tract man­u­fac­tur­er

3 years ago

Ul­tragenyx opens new gene ther­a­py man­u­fac­tur­ing site in Mass­a­chu­setts

3 years ago
Cell/Gene Tx

Catal­ent names new CFO as con­tract man­u­fac­tur­er's ef­fort to right its op­er­a­tions con­tin­ues

3 years ago
People

Bi­par­ti­san bill seeks to tight­en the do­mes­tic phar­ma sup­ply chain

3 years ago
Pharma

In­dia man­u­fac­tur­er En­zene choos­es New Jer­sey for US lo­ca­tion

3 years ago

Drug­mak­ers seek clar­i­ty from FDA on man­u­fac­tur­ing in­ter­rup­tion no­ti­fi­ca­tions

3 years ago
FDA+

Ex­clu­sive: mR­NA CD­MO Ver­nal Bio­sciences se­cures $20M to con­tin­ue its build­out

3 years ago
Financing

France looks to boost its do­mes­tic sup­ply of drugs

3 years ago

Man­u­fac­tur­ing roundup: Fer­ring looks to scale up gene ther­a­py; Eu­roAPI looks to boost pro­duc­tion of pain med­i­cine

3 years ago

To restart com­mon can­cer drug pro­duc­tion short­ly, FDA work­ing close­ly with Ac­cord

3 years ago
Pharma
FDA+

Pfiz­er says peni­cillin in­jec­tion may soon be in short sup­ply

3 years ago
Pharma

ProKid­ney to es­tab­lish cell ther­a­py man­u­fac­tur­ing site in North Car­oli­na

3 years ago
Cell/Gene Tx

$1 Dara­prim? Im­prim­is­Rx fa­cil­i­ty in New Jer­sey hit with FDA warn­ing let­ter

3 years ago
Pharma
FDA+

Charles Riv­er to work with Cu­ri­gin on gene ther­a­py treat­ment

3 years ago
Pharma
Cell/Gene Tx

Catal­ent’s Q3 rev­enue fell 19% in de­layed re­veal of fi­nan­cial re­sults

3 years ago
Financing
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