The biopharma world's manufacturing weekly

Endpoints Manufacturing

Manufacturing channel feed

CD­MOs Nephron and Can­ton each raise hun­dreds of mil­lions in fi­nanc­ing

Last year
Financing

Lon­za CEO Pierre-Alain Ruffieux to leave CD­MO amid re­duced growth

Last year
People

Bris­tol My­er­s' man­u­fac­tur­ing shut­down means low­er-than-ex­pect­ed Q3 sales for Abec­ma

Last year
Pharma

Why End­points is bring­ing a new fo­cus to our man­u­fac­tur­ing cov­er­age

Last year
Editor's note

Astel­las ear­marks $354.2M for Irish build; Sam­sung Bi­o­log­ics get in­to AD­Cs; Rentschler gets UK fa­cil­i­ty ap­proved

Last year

Q&A: Lon­za CGT pres­i­dent Daniel Pal­mac­ci talks man­u­fac­tur­ing amid low­er sales out­look

Last year
Cell/Gene Tx

FDA makes some strides in eas­ing US can­cer drug sup­ply short­ages by work­ing with man­u­fac­tur­ers

Last year
FDA+

MaaT Phar­ma and CD­MO Skyephar­ma un­veil be­spoke, and po­ten­tial­ly largest, mi­cro­bio­me fa­cil­i­ty in Eu­rope

Last year
R&D

No­var­tis is­sues vol­un­tary re­call of oral cy­closporine Sandim­mune due to crys­tal­liza­tion con­cerns

Last year
FDA+

Roche to re­file sub­cu­ta­neous Tecen­triq ap­pli­ca­tion with FDA be­fore year’s end on the back of man­u­fac­tur­ing tweaks

Last year
FDA+

Ex­pe­dit­ed CMC readi­ness pi­lot in­creas­es com­mu­ni­ca­tions be­tween FDA and spon­sors

Last year
FDA+

Man­u­fac­tur­ing tweaks to sub­cu­ta­neous Tecen­triq de­lay Roche's US launch, CMC process­es to be up­dat­ed by year’s end

Last year

Bangladeshi glau­co­ma eye drop man­u­fac­tur­er banned from sup­ply­ing prod­ucts in Eu­rope

Last year

Man­u­fac­tur­ing roundup: Bio­con ac­quires New Jer­sey man­u­fac­tur­ing site for $7M+; Ghana­ian man­u­fac­tur­er to fill-fin­ish cholera vac­cine

Last year

Ex­clu­sive: Dana­her’s ven­ture arm backs cell ther­a­py man­u­fac­tur­ing start­up co-found­ed by Carl June

Last year
Startups
Cell/Gene Tx

Cell­tri­on to build a $94M+ fa­cil­i­ty in South Ko­rea — re­port

Last year
Pharma

Au­to-in­jectable drug mak­er Ak­ti­vax cuts 70 jobs, shuts two sites as it trims scale-up plans

Last year
People

CSL Vi­for cut­ting 85 jobs in Cal­i­for­nia

Last year
People

Schott Phar­ma plans Frank­furt Stock Ex­change list­ing by end of year to boost of­fer­ing to in­jectable drug com­pa­nies

Last year
Financing
Pharma

GSK in­vests $270M in­to vac­cine man­u­fac­tur­ing in Bel­gium

Last year
Pharma

FDA aims to bet­ter in­cen­tivize qual­i­ty drug man­u­fac­tur­ing in new pro­gram

Last year
FDA+

Man­u­fac­tur­ing roundup: Eu­roAPI to ac­quire oligonu­cleotide mak­er for $10M+; EU na­tions face Trulic­i­ty short­age

Last year

Bot­u­lism risk: FDA de­liv­ers warn­ing let­ter to Gadal Labs for site mak­ing OTC pe­di­atric drugs 

Last year
FDA+

Charles Riv­er Lab­o­ra­to­ries to lay off 55 em­ploy­ees in Cal­i­for­nia

Last year
People
Discovery
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