No­var­tis and Genen­tech push for clar­i­ty from FDA on how dis­ease pro­gres­sion mod­els can be used for reg­u­la­to­ry ...

5 years ago
Pharma
FDA+

Glax­o­SmithK­line of­fers fill-fin­ish ca­pac­i­ty to No­vavax for UK sup­ply of Covid-19 vac­cine

5 years ago
Deals
Coronavirus

FDA can do more to en­sure di­ver­si­ty in clin­i­cal tri­als, ex­perts say — in­clud­ing some con­struc­tive bad­ger­ing

5 years ago
FDA+
Coronavirus

Io­n­is un­veils pos­i­tive PhII da­ta for in-house rare dis­ease drug, paving way to block­buster ri­val­ry with Take­da

5 years ago
R&D

Tem­pest Ther­a­peu­tics jumps on­to Nas­daq in merg­er with strug­gling Mil­len­do Ther­a­peu­tics; Bio­haven hits $100M mile­stone ...

5 years ago
News Briefing

It's a brave new world for So­ma­Log­ic, as the pro­teomics biotech rides Eli Cas­d­in's newest SPAC to Nas­daq with $1.2B ...

5 years ago
Financing
Deals

Look­ing to lift clin­i­cal hold, uniQure con­tends its gene ther­a­py was like­ly not the cause of sin­gle liv­er can­cer case

5 years ago
Cell/Gene Tx
FDA+

Eli Lil­ly, Glax­o­SmithK­line-Vir re­lease pos­i­tive but dif­fi­cult-to-in­ter­pret com­bo an­ti­body da­ta

5 years ago
R&D
Coronavirus

Look­ing to leave Zol­gens­ma da­ta ma­nip­u­la­tion scan­dal be­hind, Bri­an Kas­par emerges at a new gene ther­a­py play­er

5 years ago
People

FDA puts its foot down on Mak­e­na: New meta-analy­sis does not change call to pull the drug

5 years ago
Pharma
FDA+

Hu­mani­gen de­clares win in se­vere Covid-19, de­liv­er­ing much-need­ed pan­dem­ic weapon and vault­ing ahead on post-Shkre­li ...

5 years ago
R&D
Coronavirus

Bris­tol My­ers Squibb, blue­bird land once-high-stakes ap­proval on BC­MA CAR-T — and it bodes well for ri­val J&J

5 years ago
R&D

Covid-19 roundup: Mod­er­na pass­es 100M mark for US vac­cines in land­mark mo­ment; Fake Pfiz­er vac­cine found in Mex­i­co

5 years ago
R&D
Coronavirus

French court finds Servi­er guilty of manslaugh­ter in di­et pill tri­al, fines phar­ma mil­lions

5 years ago
Pharma

Or­p­hazyme's pipeline-in-a-prod­uct whiffs in sec­ond tri­al, though FDA de­ci­sion still awaits

5 years ago
R&D

As­traZeneca's Covid-19 vac­cine woes, Mon­cef Slaoui re­signs over sex­u­al ha­rass­ment claims, FDA acts tough, and more

5 years ago
Weekly

House Dems call on the FTC to in­ves­ti­gate po­ten­tial col­lu­sion among top three in­sulin man­u­fac­tur­ers

5 years ago
Pharma
FDA+

With $190M in in­vestor cash to play with, Chi­na's Chime Bi­o­log­ics looks to build 15x man­u­fac­tur­ing ca­pac­i­ty by 2024

5 years ago
Deals
Manufacturing

JSR Life Sci­ences spawns new ven­ture fund; IL-2 biotech com­pletes merg­er with triv­ia com­pa­ny sub­sidiary

5 years ago
News Briefing

Mon­cef Slaoui re­signs from post-Glax­o­SmithK­line home Medicxi af­ter ha­rass­ment al­le­ga­tions

5 years ago
People

Gilead R&D chief William Lee to re­tire as Am­gen I/O vet Flav­ius Mar­tin takes the reins in April

5 years ago
People

Mer­ck keeps it in the fam­i­ly as Robert Davis hands the CFO keys to Car­o­line Litch­field; Gilead los­es Di­ana Brainard, ...

5 years ago
Peer Review

No­var­tis push­es back on chair­man's 'i­nac­cu­rate and in­con­sis­ten­t' com­ments un­der­min­ing bribery set­tle­ment

5 years ago
Pharma

Glax­o­SmithK­line and Vir sub­mit Covid-19 mAb for emer­gency au­tho­riza­tion

5 years ago
FDA+
Coronavirus
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