Bridge­Bio team clears a key hur­dle with their proof-of-con­cept da­ta for a rare ge­net­ic dis­ease. And they can thank ...

5 years ago
R&D

Mer­ck­'s C-suite shake­up, Eli Lil­ly stirs fresh Alzheimer's con­tro­very, play by play of Am­gen's $2B buy­out, and more

5 years ago
Weekly

FDA ac­cepts Bris­tol My­er­s' pitch for for­mer MyoKar­dia drug; Clo­vis' Rubra­ca aces ad­vanced ovar­i­an can­cer study

5 years ago
News Briefing

A packed MS mar­ket is about to get busier as J&J's pones­i­mod en­ters the fray

5 years ago
Pharma
FDA+

Kiniksa touts 3rd ap­proval for ag­ing Ar­c­a­lyst — a good haul for just $5M in cash it paid Re­gen­eron for the drug

5 years ago
FDA+

The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021

5 years ago
Financing

UK drug reg­u­la­tor to restart in­spec­tions at the end of March with a fo­cus on so­cial dis­tanc­ing

5 years ago
FDA+
Coronavirus

Gone away are the blue­bird ex­ecs as COO, CMO both leave the nest; Mike Nal­ly is lat­est ma­jor fig­ure to move on from ...

5 years ago
Peer Review

Mer­ck breathes a sigh of re­lief as Keytru­da-Lenvi­ma com­bo aces con­fir­ma­to­ry study in en­dome­tri­al can­cer

5 years ago
R&D
Pharma

FDA spells out how the Covid-19 vari­ants im­pact the ef­fec­tive­ness of Re­gen­eron, Eli Lil­ly mAb treat­ments

5 years ago
FDA+
Coronavirus

Out­bid­ding 14 oth­ers and then them­selves: How Am­gen spent $2 bil­lion on a biotech that had been on the brink

5 years ago
Deals

Founders of poop-test­ing uBio­me, re­port­ed­ly on the run, charged by SEC with de­fraud­ing in­vestors

5 years ago
People

Christo­pher Austin makes his re­turn to in­dus­try, jump­ing ship from NIH over to CEO-part­ner role at Flag­ship

5 years ago
People

Jakafi failed the pri­ma­ry end­point in a Covid-19 study. But In­cyte is still go­ing to FDA with a com­pas­sion­ate use ...

5 years ago
R&D
Coronavirus

HHS post­pones re­view of over 95% of FDA’s reg­u­la­tions so crit­i­cal re­sources are not di­vert­ed from Covid-19

5 years ago
FDA+

Idera squelch­es any lin­ger­ing en­thu­si­asm as its lead TLR9 drug flunks PhI­II — bad­ly

5 years ago
R&D

Drum­roll, please: Fu­ji­film Diosynth picks North Car­oli­na as new home for $2B cell-cul­ture su­per­plant

5 years ago
Manufacturing

Drug­mak­ers brace for a pric­ing fight as Xavier Be­cer­ra is con­firmed as the next HHS sec­re­tary

5 years ago
People
Pharma

In­side No­var­tis' months-long ef­forts to scale their ri­val­s' Covid-19 vac­cines

5 years ago
Coronavirus
Manufacturing

Re­call re­port: Sagent Phar­ma pulls low blood pres­sure med for loose seal­ing on ster­ile vials

5 years ago
FDA+
Manufacturing

Catal­ent amps up plans to man­u­fac­ture J&J's Covid-19 vac­cine, adding vial fill­ing line in Italy

5 years ago
Manufacturing

Covid-19 man­u­fac­tur­ing roundup: Catal­ent, As­traZeneca de­fend vac­cine batch qual­i­ty in safe­ty row — FT; US buys more ...

5 years ago
Coronavirus
Manufacturing

EMA calls for As­traZeneca vac­ci­na­tions to con­tin­ue af­ter safe­ty scares de­layed roll­out

5 years ago
FDA+
Coronavirus

Mer­ck KGaA adds 350 work­ers at French site to build ca­pac­i­ty for 's­in­gle-use' tech for Covid-19 vac­cines, ther­a­pies

5 years ago
Outsourcing
Manufacturing
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