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Endpoints Manufacturing

Manufacturing channel feed

Sam­sung Bi­o­log­ics touts Q2 per­for­mance af­ter ex­pand­ing deals with big phar­mas

Last year

Finnish man­u­fac­tur­er to in­vest $55M+ in new fa­cil­i­ty for AAV ther­a­pies

Last year
Pharma
Cell/Gene Tx

Ex­clu­sive: Cell ther­a­py CD­MO Kin­cell launch­es, and the spin­out is val­ued at $66M, with CEO look­ing for carve-outs

Last year
Cell/Gene Tx

Dam­aged Pfiz­er plant re­mains closed as wor­ries mount about short­ages of ster­ile in­jecta­bles

Last year

Lon­za cites biotech fund­ing slow­down as it low­ers sales out­look for the year

Last year
Financing

Man­u­fac­tur­ing roundup: Ac­tivist in­vestor re­port­ed­ly takes stake in Catal­ent; ProKid­ney caps off pur­chase of NC man­u­fac­tur­ing site

Last year

FDA re­ports short­age of No­vo Nordisk's weight loss drug Sax­en­da

Last year
Pharma

Tor­na­do se­vere­ly dam­ages Pfiz­er's large ster­ile in­jectable plant in North Car­oli­na

Last year
Pharma

WHO sounds the alarm over more con­t­a­m­i­nat­ed cough syrup in Africa

Last year
Pharma

House Re­pub­li­cans ques­tion FDA's progress on phar­ma in­spec­tions in In­dia and Chi­na

Last year
FDA+
Law

In­gre­di­ent man­u­fac­tur­er Cen­taur gets FDA warn­ing over records, sub­stan­dard clean­ing

Last year
Pharma
FDA+

Man­u­fac­tur­ers, in­dus­try groups com­ment on FDA’s con­trol over ni­trosamines in drug prod­ucts

Last year
Pharma
FDA+

EU prepar­ing for pos­si­ble an­tibi­ot­ic short­age in the win­ter

Last year
Pharma

FDA cites clean­ing, main­te­nance is­sues at Catal­ent fa­cil­i­ty re­spon­si­ble for Re­gen­eron’s drug re­jec­tion

Last year
People
FDA+

No­vo Nordisk set to boost We­govy sup­plies with sec­ond man­u­fac­tur­er ready, and a third get­ting clos­er

Last year
Pharma
Marketing

FDA backs new $82M mR­NA man­u­fac­tur­ing cen­ter at MIT

Last year
Pharma
Cell/Gene Tx

Man­u­fac­tur­ing roundup: Cipla re­calls al­buterol dos­es over de­fect in the con­tain­er; Cell and gene ther­a­py man­u­fac­tur­er se­cures Se­ries A

Last year

Mer­ck KGaA, Mil­li­pore­Sig­ma make in­vest­ments in the US and Chi­na man­u­fac­tur­ing

Last year
China

OTC nasal, ear care prod­uct man­u­fac­tur­er hand­ed a warn­ing let­ter

Last year
Pharma

Up­dat­ed: FDA to im­port more of com­mon can­cer drug from Chi­na af­ter In­di­an site clo­sure

Last year
China
Pharma

Xspray Phar­ma hand­ed CRL from US reg­u­la­tors seek­ing more in­for­ma­tion about leukemia treat­ment

Last year
FDA+

No­var­tis and Sam­sung ink five-year, $309M ex­pan­sion to bi­o­log­ics man­u­fac­tur­ing part­ner­ship

Last year

Pfiz­er adds shifts, in­vests re­sources to cope with surge in de­mand for syphilis treat­ment

Last year
Pharma

FDA shifts how it pri­or­i­tizes which phar­ma sites to in­spect

Last year
R&D
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