Ku­ra’s stock jumps on PhIb read­out; FDA lifts hold on IN­mune Bio pro­gram; Nanobi­otix’s $20M mile­stone

Last year
News Briefing

Avro­bio makes way for GPCR biotech Tec­ton­ic Ther­a­peu­tic in re­verse merg­er

Last year
Startups
Deals

Hims CEO says he'd rather go af­ter ri­val­s' cus­tomers than buy their busi­ness­es

Last year
Health Tech

Gilead, Kite short­en Yescar­ta man­u­fac­tur­ing by two days in 'in­cre­men­tal' im­prove­ment

Last year
Cell/Gene Tx
Manufacturing

Ex­clu­sive: Eli Lil­ly sup­plied schiz­o­phre­nia drug to un­cer­ti­fied health­care providers, Form 483 shows

Last year
Pharma
FDA+

Cor­rect­ed: 2sev­en­ty bio sells R&D unit to Re­gen­eron for $5M up­front, cuts ad­di­tion­al staff

Last year
Deals

Pfiz­er's Q4 rev­enue tum­bles 42% amid Covid re­set

Last year
Pharma

Gilead in­vests an­oth­er $320M in Ar­cus as part­ners re­hash their TIG­IT pact

Last year
Deals
R&D

Ex­clu­sive: Jnana says piv­otal tri­al of PKU pill could be­gin next year af­ter promis­ing re­sults from a small­er study

Last year
R&D

Ver­tex’s pain drug suc­ceeds in late-stage stud­ies, mark­ing ma­jor break­through in search for new, non-opi­oid ...

Last year
R&D

Chica­go-area au­toim­mune biotech gets phar­ma back­ing in $105M round for two PhII tri­als

Last year
Financing
Startups

Ex­clu­sive: Weight loss app Noom lays off em­ploy­ees in­clud­ing coach­es and en­gi­neers

Last year
Health Tech

CAR NK biotech Cata­ma­ran Bio to wind down, will seek part­ners for cell ther­a­pies

Last year
People
Cell/Gene Tx

Ex­it in­ter­view: FDA leg­end Janet Wood­cock­'s thoughts on the agency and its con­tro­ver­sies

Last year
People
FDA+

Ju­ry awards Nat­era $96M+ in blood test patent fight

Last year
Pharma
Law

FDA sched­ules March ODAC for Geron's MDS drug fol­low­ing PhI­II da­ta

Last year
R&D
FDA+

FDA up­dates draft guid­ance on race and eth­nic­i­ty re­port­ing in clin­i­cal tri­als

Last year
FDA+

GSK shoots for RSV la­bel ex­pan­sion in younger adults in Eu­rope in race against Pfiz­er’s Abrys­vo

Last year
Pharma
FDA+

FDA fi­nal­izes CAR-T and gene ther­a­py guid­ance, of­fers sup­port for ac­cel­er­at­ed ap­provals

Last year
Cell/Gene Tx
FDA+

Sarep­ta shares PhII da­ta for next-gen ex­on skip­ping drug, but reg­u­la­to­ry path­way is un­clear

Last year
R&D

As­cendis spins out oph­thal­mol­o­gy com­pa­ny; Gami­da Cell eyes strate­gic op­tions

Last year
News Briefing

Roche ends KRAS deal with Hookipa Phar­ma, as biotech lays off 30% of staff

Last year
People
Deals

Mid-stage CNS biotech Al­to Neu­ro­science plots $89M IPO

Last year
Financing
Startups

De­cen­tral­ized tri­als com­pa­ny Sci­ence 37 to go pri­vate in deal with di­ag­nos­tics start­up eMed

Last year
Startups
Deals
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