More in­fo on drug re­view time­lines? HHS and FDA pull Trump HHS’ last-minute pledge

5 years ago
Pharma
FDA+

Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at ...

5 years ago
Peer Review

Bob­bing on a sea of crises, blue­bird's Nick Leschly sees his pay cut in half as the biotech pre­pares to split

5 years ago
People
Pharma

House com­mit­tee to grill Ab­b­Vie CEO next month on sup­press­ing Hu­mi­ra com­pe­ti­tion

5 years ago
Pharma

FDA hits Leo Phar­ma with a CRL for what the biotech says are ques­tions about the 'de­vice com­po­nen­t' of eczema ...

5 years ago
FDA+

Emer­gent reshuf­fles its man­u­fac­tur­ing brain trust as CEO sends mixed mes­sages around Covid-19 vac­cine de­ba­cle

5 years ago
Coronavirus
Manufacturing

Stan­ley Er­ck bagged $48M in pay as he guid­ed No­vavax on a re­mark­able turn­around in the hunt for a Covid-19 vac­cine

5 years ago
People
Coronavirus

The com­pa­ny be­hind As­traZeneca's Covid-19 vac­cine just went pub­lic, weeks af­ter com­plet­ing mon­ster Se­ries B, as ...

5 years ago
Financing

Covid-19 roundup: As­traZeneca strug­gling to com­pile da­ta for FDA OK — re­port

5 years ago
Coronavirus

Mer­ck, Roche and Bris­tol My­ers nab 4 of 6 pos­i­tive ODAC votes for ‘dan­gling’ ac­cel­er­at­ed ap­provals

5 years ago
R&D
Pharma

Covid-19 man­u­fac­tur­ing roundup: Catal­ent adds freez­er part­ner for vac­cine pro­duc­tion push; In need of vol­un­teers, ...

5 years ago
Coronavirus
Manufacturing

AskBio bails on in-li­censed gene ther­a­py pro­gram af­ter find­ing is­sues with 3rd-par­ty man­u­fac­tur­er

5 years ago
R&D
Manufacturing

Sam­sung Bi­o­log­ics, TG Ther­a­peu­tics ink deal to mass pro­duce MS hope­ful ubli­tux­imab

5 years ago
Outsourcing
Manufacturing

Ken Fra­zier ends his 29-year tenure at Mer­ck on a sour note, re­veal­ing a dip in sales in his fi­nal earn­ings call

5 years ago
Pharma

Ther­mo Fish­er has flour­ished amid the pan­dem­ic, but can it keep the ball rolling when Covid-19 comes to a close?

5 years ago
Outsourcing
Manufacturing

Cara touts sub­group in failed atopic der­mati­tis tri­al, but stock craters

5 years ago
R&D

Galera claims pos­i­tive up­date in pan­cre­at­ic can­cer but does­n't re­port p-val­ues; Am­gen launch­es Cana­di­an fund in ...

5 years ago
News Briefing

Star­ing at a down quar­ter for Op­di­vo, Bris­tol My­ers keeps its eyes on price com­pe­ti­tion po­ten­tial in packed PD-1 ...

5 years ago
Pharma

FDA pan­dem­ic de­lays strike again with Is­raeli mi­cro­cap the lat­est to re­ceive a CRL based on in­spec­tion set­backs

5 years ago
FDA+

Sanofi is ex­pand­ing at light speed abroad, but it's leav­ing be­hind a Penn­syl­va­nia plant and its 75 em­ploy­ees

5 years ago
Pharma
Manufacturing

Forge Bi­o­log­ics bags $120M round as it looks to scale AAV man­u­fac­tur­ing for Krabbe dis­ease treat­ment

5 years ago
Financing
Manufacturing

Lon­za adds on small mol­e­cule fa­cil­i­ty at Visp site, adding new weight to its ex­pan­sion plans on the back of a big ...

5 years ago
Outsourcing
Manufacturing

Covid-19 roundup: Atea Phar­ma­ceu­ti­cals launch­es an­tivi­ral in­to PhI­II tri­al; Cell­tri­on's an­ti­body shows promise ...

5 years ago
Coronavirus

A new gene ther­a­py play­er de­buts in LA with 2 start­up VCs at its back, Ab­b­Vie on board with a $90M cash up­front and ...

5 years ago
Startups
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