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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

3 years ago
R&D

Rel­ma­da makes 'crit­i­cal changes' to PhI­II tri­al to try and save de­pres­sion drug

3 years ago
R&D

NK cell ther­a­py-fo­cused biotech eyes SPAC deal

3 years ago
Deals

In­cyte hit by CRL on ex­tend­ed-re­lease JAK tablets, mud­dy­ing plans for Jakafi fran­chise ex­pan­sion

3 years ago
Pharma
FDA+

Hard pressed for cash, Cy­cle­ri­on looks for help fund­ing rare dis­ease drug

3 years ago
R&D

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

3 years ago
R&D
China

Three­'s a crowd as an­oth­er Kite ex­ec hits the ex­it; Surf­ing tough wa­ters, Celyad On­col­o­gy picks up new CEO

3 years ago
Peer Review

Pa­tients ap­peal NI­H's re­jec­tion to use 'march-in' rights on Astel­las' prostate can­cer drug Xtan­di

3 years ago
Law

Take­da and Lund­beck change tac­tics on Trin­tel­lix de­pres­sion cam­paign

3 years ago
Pharma
Marketing

Eu­ro­pean Com­mis­sion de­lays pro­pos­al for ma­jor changes to phar­ma leg­is­la­tion

3 years ago
Pharma
FDA+

Bris­tol My­ers’ ‘Liv­ing’ doc­u­men­tary ties to­geth­er peo­ple man­ag­ing health con­di­tions

3 years ago
Pharma
Marketing

Se­cu­ra Bio to keep of­fer­ing blood can­cer drug de­spite neg­a­tive ODAC vote, OS ques­tions

3 years ago
Pharma

J&J los­es at­tempt to ex­tend patent in In­dia for tu­ber­cu­lo­sis drug

3 years ago
Pharma

White House un­veils ‘bold goals’ for US bio­man­u­fac­tur­ing ef­forts

3 years ago
Pharma
Manufacturing

Con­tract man­u­fac­tur­er Cu­ria names new CEO

3 years ago
People
Manufacturing

Take­da in­vests $760M+ in­to new plas­ma-de­rived ther­a­py man­u­fac­tur­ing site in Japan

3 years ago
Pharma
Manufacturing

Man­u­fac­tur­ing roundup: Cana­da to in­vest $58M+ in­to 'crit­i­cal' med­i­cines man­u­fac­tur­ing; FDA to ac­cept apps for CMC ...

3 years ago
Manufacturing

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

3 years ago
Deals
R&D

Roy­al­ty Phar­ma hands off $100M up­front for PureTech roy­al­ty on Karuna's schiz­o­phre­nia hope­ful

3 years ago
Deals
R&D

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

3 years ago
Startups
Deals

FDA ap­proves Cidara's Rez­za­yo as an­ti­fun­gal treat­ment for can­didemia and in­va­sive can­didi­a­sis

3 years ago
R&D
FDA+

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

3 years ago
People

Sanofi, Re­gen­eron boast PhI­II win with Dupix­ent in COPD, clear­ing first bar for ex­pan­sion

3 years ago
R&D
Pharma

Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

3 years ago
People
Manufacturing
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