Gilead’s Dan O’Day pulls the plug on the li­on’s share of their fil­go­tinib col­lab­o­ra­tion as the FDA erects a high safe­ty bar­ri­er. What went wrong?

Last month
Deals
Regulatory

They thought their gene ther­a­py failed. In­stead, it spawned a med­ical mys­tery

Last month
Discovery
In Focus

FDA docs give Mod­er­na green light, while spot­light­ing dif­fer­ences with Pfiz­er

Last month
Regulatory
Coronavirus

Joe Jimenez forges an­oth­er big-mar­ket, small-cash deal, lin­ing up a kid­ney dis­ease drug for his lat­est port­fo­lio start­up

Last month
Deals

Eli Lil­ly picks up gene ther­a­py play­er Pre­vail in deal worth $1B+, mak­ing good on bolt-on pledge from ear­li­er this year

Last month
Deals
Cell/Gene Tx

FDA slaps a hold on a star Re­gen­eron can­cer drug, paus­ing tri­al en­roll­ment as cy­tokine storms trig­ger new tox tem­pest

Last month
Regulatory

Covid-19 roundup: Trump walks back plans to pri­or­i­tize White House staff for vac­cine; As­traZeneca drops sub­group of chil­dren from vac­cine tri­al — re­port

Last month
Coronavirus

In an end-of-year sur­prise, As­traZeneca nabs rare dis­ease stal­wart Alex­ion in $39B buy­out. But why?

Last month
Deals

Glob­al Blood Ther­a­peu­tics re­cruits a CHOP sick­le cell ex­pert as R&D chief; Catal­ent plucks Janssen vet to head new clin­i­cal pack­ag­ing fa­cil­i­ty

Last month
Peer Review

De­spite flop­ping piv­otal tri­al, No­var­tis' En­tresto will face ad­comm fir­ing line for holy grail heart fail­ure pa­tients

Last month
Pharma
Regulatory

An EUA is com­ing, FDA tells Pfiz­er

Last month
Regulatory
Coronavirus

Covid-19 roundup: As­traZeneca team finds a sur­prise Covid-19 vac­cine part­ner; Bio­gen con­fer­ence linked to 300K cas­es

Last month
Coronavirus

Ad­vi­so­ry com­mit­tee votes 17-4 to rec­om­mend FDA au­tho­rize Pfiz­er-BioN­Tech vac­cine, open­ing door to rapid EUA

Last month
Regulatory
Coronavirus

Boehringer In­gel­heim buys out next-gen ADC play­er NBE-Ther­a­peu­tics in a deal worth up to $1.4B+

Last month
Deals

'Are you guys out of vi­rol­o­gy?': Not hard­ly, says Gilead ex­ecs, as they buy a late-stage drug com­pa­ny for $1.7B

Last month
Deals

Covid-19 roundup: Mod­er­na be­gins PhII/III vac­cine study in ado­les­cents; Pfiz­er and BioN­Tech's vac­cine gets an OK in Cana­da as the FDA meets to dis­cuss emer­gency use

Last month
Coronavirus

Ad­vo­ca­cy group ac­cus­es FDA neu­ro chief Bil­ly Dunn of mis­con­duct in con­tro­ver­sial Bio­gen re­view, de­mands a purge and fed­er­al probe

Last month
R&D
Regulatory

Less than a year af­ter leav­ing Al­ler­gan, Brent Saun­ders has a $1.1B deal to take his SPAC pub­lic

Last month
Deals

As­traZeneca pub­lish­es in­ter­im vac­cine da­ta in Lancet, re­veals 10 hos­pi­tal­iza­tions, 1 death in piv­otal con­trol arms

Last month
Regulatory
Coronavirus

FDA in­ter­nal re­view points to im­mi­nent Pfiz­er/BioN­Tech EUA, spot­lights po­ten­tial for sin­gle-dose vac­ci­na­tion

Last month
Regulatory
Coronavirus

A KRAS drug is like­ly com­ing — fast — as the FDA points Am­gen’s fron­trun­ner to a loom­ing fin­ish line

Last month
R&D
Regulatory

Glax­o­SmithK­line R&D vet Min Li nabs $100M to launch a Bob Nelsen-backed start­up fo­cused on Chi­na’s bur­geon­ing neu­ro mar­ket

Last month
Financing
Startups

#ASH20 saw a BC­MA brawl. Who's still stand­ing? And who got knocked out for good?

Last month
R&D
Pharma

Carl Hansen is just about ready to grab the key to the ex­clu­sive Cov­il­lion­aire club

Last month
People
Bioregnum
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