Over­worked and ready for ex­pan­sion: FDA's cell and gene ther­a­py of­fice preps to add about 100 new po­si­tions

3 years ago
Cell/Gene Tx
FDA+

Lipocine shifts fo­cus to CNS; Drug ap­proval trig­gers cap­i­tal in­fu­sion at Fen­nec

3 years ago
News Briefing

Seagen tees up with Dutch I/O out­fit, en­gi­neers $700M deal for EGFR as­set

3 years ago
Deals

Ar­cutis' for­mu­la­tion of old As­traZeneca drug clears an­oth­er PhI­II test

3 years ago
R&D

FDA's top gener­ic drug leader puts in her two weeks as GDU­FA III looms

3 years ago
People
FDA+

Val­ne­va’s sec­ond-gen Covid vac­cine plans up in the air as it looks for part­ner

3 years ago
Coronavirus

Covid-19 roundup: Pfiz­er, BioN­Tech kick off EUA dance for teen bi­va­lent shot; Re­port de­tails slow US boost­er roll­out

3 years ago
Coronavirus

Ru­bik's Cube still not solved at Mereo as ac­tivist in­vestor re­jects biotech's of­fer for board seats

3 years ago
People

With con­sumer health be­hind it, GSK taps As­traZeneca vet Julie Brown as CFO for R&D-fo­cused fu­ture

3 years ago
People

Liv­er-fo­cused start­up nabs $115M in ex­change for rare dis­ease drug roy­al­ties

3 years ago
Financing

They’re go­ing for it: David Liu’s pre­clin­i­cal biotech shoots for a (maybe $200M) IPO

3 years ago
Financing

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

3 years ago
Weekly

As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

3 years ago
R&D

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

3 years ago
Manufacturing

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

3 years ago
Pharma
FDA+

FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

3 years ago
FDA+

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

3 years ago
Pharma
Law

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

3 years ago

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

3 years ago
Pharma
Manufacturing

What can phar­ma do to re­build trust in sci­ence? For­mer Pres­i­dent Oba­ma has some ideas — and oth­er thoughts for the ...

3 years ago
Pharma
Marketing

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

3 years ago
Coronavirus

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

3 years ago
Pharma
Marketing

Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

3 years ago
Coronavirus

Pre­ci­sion on­col­o­gy biotech agrees to $72M cash in­fu­sion as it seeks to in­crease rev­enue

3 years ago
Financing
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