Safe­ty con­cerns push FDA ad­comm to vote over­whelm­ing­ly against ap­proval for Fi­bro­Gen ane­mia drug

4 years ago
Pharma
FDA+

As in­ves­ti­ga­tions mount and con­tro­ver­sy swirls, Bio­gen fights back against ICER — and then faces an­oth­er unan­i­mous ...

4 years ago
FDA+

'They have shown that this is not some im­pos­si­ble thing': Aca­d­e­m­ic lab copies Google’s big bi­o­log­i­cal break­through

4 years ago
Discovery

CD­MO AM­RI re­brands and snags a pair of small­er com­pa­nies to aid its shift to be­come a glob­al brand name

4 years ago
R&D
Manufacturing

Gen­er­a­tion Bio snaps up Boston area plant as it rolls out a man­u­fac­tur­ing process it thinks will be a game chang­er

4 years ago
R&D
Manufacturing

Catal­ent lands 2 new part­ner­ships, in­clud­ing for glioblas­toma drug; US drops $153M in­to pan­dem­ic pre­pared­ness

4 years ago
Outsourcing
Manufacturing

As its next big bet, Sana inks long-term lease for man­u­fac­tur­ing site for next-gen cell ther­a­pies

4 years ago
Cell/Gene Tx
Manufacturing

UK busi­ness sec­re­tary look­ing in­to Philip Mor­ris' pro­posed deal to ac­quire Vec­tura — re­port

4 years ago
Deals

Eli Lil­ly part­ners with Alzheimer's cen­ter for PhI­II study; New tu­ber­cu­lo­sis con­sor­tium emerges in $218M+ project

4 years ago
News Briefing

With Mod­er­na shares fly­ing at a pan­dem­ic high, the mar­ket cap has now pierced the $100B mark, leapfrog­ging ...

4 years ago
Bioregnum

Mak­ing a name for it­self in Covid-19 test­ing, Hong Kong's Pre­net­ics is the lat­est biotech SPAC merg­er — re­port

4 years ago
Financing

Gala­pa­gos dis­ap­points again as 2 key read­outs fail to gen­er­ate much en­thu­si­asm for Gilead­'s fad­ing part­ner

4 years ago
R&D

Al­ready sit­ting on a ma­jor stem cell bank, Gen­er­ate looks to grow its re­gen­er­a­tive med­i­cines busi­ness

4 years ago
Outsourcing
Manufacturing

EX­CLU­SIVE: Shape Ther­a­peu­tics rais­es $112M in bid to make RNA edit­ing — and a whole lot else — a re­al­i­ty

4 years ago
Financing
Cell/Gene Tx

Covid-19 man­u­fac­tur­ing roundup: FDA frees up more Emer­gent vac­cine dos­es; Pfiz­er and Viet­nam dis­cuss tech trans­fer ...

4 years ago
Coronavirus
Manufacturing

Covid-19 roundup: As­traZeneca hits vac­cine dis­tri­b­u­tion snag in Thai­land; Chi­na com­pletes ex­pert re­view of BioN­Tech's ...

4 years ago
Coronavirus

Ma­jor health sys­tems refuse to ad­min­is­ter Aduhelm as top FDA lead­ers meet be­hind closed doors to talk with pay­ers

4 years ago
Pharma
FDA+

A Chi­nese I/O biotech look­ing to turn around an old No­var­tis pro­gram gets a new fundraise af­ter launch­ing PhI­II study

4 years ago
Financing

A stealthy start­up is lever­ag­ing nat­ur­al killer cells with 'mem­o­ry-like' abil­i­ties to go af­ter blood can­cer and ...

4 years ago
Financing
Cell/Gene Tx

Dis­cov­ery by Shang­hai sci­en­tists in­spires new plan of AT­TEC for pro­tein degra­da­tion

4 years ago
Financing
Startups

Ad­u­canum­ab has its ap­proval — now, let cit­i­zen-sci­en­tists come to­geth­er to see if it works

4 years ago
Biotech Voices

Tom Lynch moves to re­struc­ture Fred Hutch as acad­e­mia, in­dus­try con­tin­ue to push cell ther­a­py in­to sol­id tu­mors

4 years ago
R&D

Bank­ing on shared ex­pe­ri­ences — and now a big in­vestor — with broth­er Vivek, Shankar Ra­maswamy stacks up a $100M ...

4 years ago
R&D

FDA chides Am­gen over mis­lead­ing ban­ner ad for Neu­las­ta

4 years ago
Pharma
FDA+
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