New drug ap­pli­ca­tions pile up with de­lays as there's no easy fix for the in­spec­tion back­log

4 years ago
Manufacturing

House com­mit­tee wants for­mer FDA com­mis­sion­er to come clean on Covid-re­lat­ed po­lit­i­cal in­ter­fer­ence

4 years ago
FDA+

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

4 years ago
Deals

Bio­gen pulls PRIME des­ig­na­tion for ad­u­canum­ab in Eu­rope; Mer­ck clos­es merg­er with Ac­celeron

4 years ago
News Briefing

Sanofi con­tin­ues mR­NA push in wake of Covid vac­cine set­back, part­ner­ing with Chi­na tech gi­ant Baidu

4 years ago
Deals
AI

NeuEx­cell heads east, land­ing sub­ur­ban Philly head­quar­ters

4 years ago
Cell/Gene Tx
Manufacturing

Af­fimed spurs promis­ing re­sponse num­bers in NK cell study, but dura­bil­i­ty will be the big ques­tion

4 years ago
R&D
Cell/Gene Tx

Rafael Hold­ings guts its top lead­er­ship, in­clud­ing short-tenured CEO, as can­cer fi­as­co spurs a shake­up

4 years ago
People

Blue­bird bio may fi­nal­ly get a gene ther­a­py ap­proved in the US

4 years ago
R&D
Cell/Gene Tx

BioCryst gets mas­sive cash in­fu­sion to the tune of $350M, thanks to old and new in­vestors

4 years ago
Financing

Bounc­ing back from a PhII flop in schiz­o­phre­nia, Neu­ro­crine steers in­to the busy M4/M1 path­way with a $100M cash deal

4 years ago
Deals
R&D

Glax­o­SmithK­line's Trel­e­gy ad change-up spurs bet­ter re­lata­bil­i­ty with COPD pa­tients — and more doc­tor con­ver­sa­tions

4 years ago
Pharma
Marketing

The an­ti­body dis­cov­ery team at Twist bets on mouse mod­el play­er in a boost to its port­fo­lio

4 years ago
Deals
Discovery

Xen­cor says good­bye to its for­mer lead drug, sell­ing all rights to Lon­nie Moul­der's new start­up

4 years ago
Deals

New Pfiz­er/BioN­Tech Covid vac­cine da­ta in teens show strong pro­tec­tion, lin­ing up sBLA fil­ing

4 years ago
FDA+
Coronavirus

Two of Chi­na's top PD-(L)1 play­ers team up on CT­LA-4 in $200M deal

4 years ago
Deals
China

Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

4 years ago
Pharma
Marketing

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

4 years ago
Deals

Bio­gen’s no good week; In­side gene edit­ing's open se­cret; No­vo Nordisk ab­sorbs RNAi part­ner; Boost­ers for all; and ...

4 years ago
Weekly

FDA opens up an eth­i­cal can of worms with ac­cel­er­at­ed ap­proval for first drug for un­der­ly­ing ge­net­ic cause of ...

4 years ago
FDA+

Covid-19 roundup: Ahead of FDA, EU signs off on Mer­ck­'s an­tivi­ral; Dis­tri­b­u­tion of mAbs in US see first uptick in 7 ...

4 years ago
Coronavirus

Cy­tovia, Cel­lec­tis add CAR-T tar­gets to pre­ex­ist­ing cell ther­a­py pact; Bridge­Bio, Helsinn un­veil first pro­gram in R&D ...

4 years ago
News Briefing

FDA de­lays its de­ci­sion on Bris­tol My­er­s' $13B heart drug an­oth­er three months

4 years ago
R&D
FDA+

Con­nect Bio­phar­ma cel­e­brates a mid-stage win for its Dupix­ent ri­val, but shares tank af­ter in­vestors clam­or for da­ta

4 years ago
R&D
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