Covid-19 roundup: EMA of­fers ear­ly ac­cess to Pfiz­er's pill Paxlovid; Val­ne­va fires back with boost­er da­ta of its own

4 years ago
Coronavirus

Cal­lid­i­tas nabs ac­cel­er­at­ed OK for rare kid­ney dis­ease, beat­ing two com­peti­tors to the punch

4 years ago
FDA+

FDA seeks FTC ac­tion af­ter re­ject­ing pe­ti­tion to block first gener­ics for decades-old va­so­pressin

4 years ago
Pharma
FDA+

Ital­ian can­cer gene ther­a­py biotech makes his­to­ry with mod­est Nas­daq IPO

4 years ago
Financing

Al­ice Zhang's 'all-in-hu­man' AI and ge­nomics up­start scores a $98M Se­ries B

4 years ago
Financing
AI

Bio­gen re­veals plans for con­fir­ma­to­ry Aduhelm study, promis­ing re­sults in 5 years

4 years ago
R&D
FDA+

Idera Phar­ma­ceu­ti­cal­s' stock tanks af­ter Ab­b­Vie cuts en­roll­ment ear­ly in a PhIb tri­al

4 years ago
R&D

Op-ed: 5 un­set­tled is­sues a Califf-run FDA will need to tack­le in 2022 and be­yond

4 years ago
FDA+

Keros gives Han­soh sub­sidiary li­cense for lead drug in $190M+ deal; Vac­citech snaps up new tools in small buy­out 

4 years ago
News Briefing

Eli Lil­ly promis­es five new ap­provals in next two years with Alzheimer’s at the fore­front

4 years ago
R&D

Rid­ing an ADC hot streak, a new biotech bets a megaround that a bet­ter ver­sion of those ther­a­pies is­n't a myth

4 years ago
Financing

#JPM22 goes vir­tu­al, cav­ing to pres­sure af­ter a wave of big drug­mak­ers pull out due to Omi­cron fears

4 years ago
Pharma

A new eye-fo­cused biotech is out of stealth, with plans to bar­rel to­ward PhII stud­ies

4 years ago
Startups

US paus­es dis­tri­b­u­tion of GSK/Vir's Covid mAb not due to Omi­cron, but greater sup­ply of Eli Lil­ly mAbs

4 years ago
Coronavirus

Amid safe­ty con­cerns, FDA grants two new JAK ap­provals — but with added warn­ings and a key la­bel change

4 years ago
FDA+

A new an­ti­body treat­ment of­fers long-await­ed hope for im­muno­com­pro­mised pa­tients, if Omi­cron does­n't get here first

4 years ago
Coronavirus
In Focus

BeiGene slides on Shang­hai de­but as US preps to black­list some Chi­nese biotechs

4 years ago
Financing

Sanofi and Glax­o­SmithK­line: Those PhI­II Covid-19 vac­cine re­sults you’ve been wait­ing for? Wait longer (but here's ...

4 years ago
Pharma
Coronavirus

Hopes for non-vi­ral gene ther­a­py take a blow as Gen­er­a­tion Bio an­nounces sig­nif­i­cant set­back

4 years ago
Cell/Gene Tx

#ASH21: The Jay Brad­ner in­ter­view: 'We're work­ing up a good­ly num­ber of deal­s'

4 years ago
Cell/Gene Tx

Mar­ket­ingRx roundup: J&J’s chief comms of­fi­cer set to re­tire; Te­va opi­oid case held up af­ter heat­ed at­tor­ney ...

4 years ago
Pharma
Marketing

Clin­i­cal tri­als at lo­cal phar­ma­cies? A nat­ur­al fit and more like­ly than ever: an­a­lyst

4 years ago
Pharma
Marketing

Sen­ate health com­mit­tee again of­fers its sup­port for FDA com­mis­sion­er nom­i­nee Rob Califf

4 years ago
FDA+

Boston-based lab provider to open sec­ond Bay Area lo­ca­tion

4 years ago
Manufacturing
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