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Endpoints Manufacturing

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Com­peti­tor man­u­fac­tur­ers could ben­e­fit from No­vo’s ac­qui­si­tion of Catal­ent, Siegfried CEO says

Last year

Dai­ichi Sankyo in­vests $1B to bulk out Ger­man site for can­cer AD­Cs 

Last year

Bio­phar­ma man­u­fac­tur­ers call for clar­i­ty on FDA's ad­vanced des­ig­na­tion guid­ance 

Last year
FDA+

No­vo-Catal­ent deal like­ly to be one-off — with some caveats, in­sid­ers say

Last year
Deals

VBI sells vac­cine and fa­cil­i­ty for $33M; Bay­er gets ra­dioiso­topes from Pan­Tera; Ther­mo Fish­er’s PPD ex­pands of­fer­ings

Last year

Charles Riv­er’s CD­MO rev­enue rise; Catal­ent lays off 300 staffers; Bio­gen’s idle ca­pac­i­ty

Last year

Law­mak­ers call for US in­ves­ti­ga­tion of Chi­nese con­tract re­search gi­ants

Last year
Pharma

FDA de­lays PDU­FA date for Rock­et’s rare white blood cell dis­or­der gene ther­a­py

Last year
FDA+

Af­ter 'mis­lead­ing' in­for­ma­tion de­lays FDA in­spec­tion, Chi­nese API man­u­fac­tur­er hit with an OAI

Last year
FDA+

Catal­ent, which is be­ing ac­quired by No­vo, re­ports 10% drop in sec­ond-quar­ter rev­enue

Last year

As­traZeneca on 'in­de­pen­den­t' man­u­fac­tur­ing; Sam­sung Bio's next ADC deal

Last year

Catal­ent’s In­di­ana site clos­es out three Form 483s in past two years

Last year
FDA+

BioN­Tech, Au­to­lus strike wide-rang­ing li­cens­ing and man­u­fac­tur­ing deal for CAR-T ther­a­pies

Last year
Deals
Cell/Gene Tx

Lil­ly CEO rais­es con­cerns about No­vo-Catal­ent buy, call­ing the No­vo Nordisk deal ‘un­usu­al’

Last year
Deals

Ex­clu­sive: With an eye to­ward ex­pan­sion, an AI com­pa­ny that sup­ports CD­MOs com­pletes $20M Se­ries C raise

Last year
Financing

Lil­ly to build man­u­fac­tur­ing ca­pac­i­ty at risk to pre­pare for next-gen oral obe­si­ty drug

Last year
Pharma

Law­mak­ers hold FDA for­eign in­spec­tion prac­tices un­der mi­cro­scope at hear­ing with­out agency at­ten­dance

Last year
Pharma
FDA+

Be­hind gener­ic drug short­ages, House com­mit­tee points to lack­lus­ter man­u­fac­tur­ing and high prices

Last year
FDA+

Four burn­ing ques­tions about the fu­ture of the $16.5B No­vo-Catal­ent deal

Last year
Deals

Up­dat­ed: No­vo Hold­ings pays $16.5B to take Catal­ent pri­vate — and sells three man­u­fac­tur­ing sites to No­vo Nordisk

Last year
Deals

AGC Bi­o­log­ics hit with 483 for poor dis­crep­an­cy in­ves­ti­ga­tion prac­tices, qual­i­ty con­trol is­sues at Wash­ing­ton site

Last year
Pharma
FDA+

Ther­mo Fish­er mulls Irish site ex­it; Alvotech’s new Form 483; Catal­ent as­sists with We­govy man­u­fac­tur­ing

Last year

Due to ‘over­whelm­ing de­mand,’ Sanofi and As­traZeneca’s RSV an­ti­body to be in lim­it­ed sup­ply 

Last year
Pharma

Up­dat­ed: Mer­ck gives few de­tails on 2024 re­struc­tur­ing plan for man­u­fac­tur­ing net­work

Last year
Pharma
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