Pharma channel feed

Wood­cock de­tails up­com­ing changes to NDA and BLA re­view process

7 years ago

Sanofi's con­tro­ver­sial dengue vac­cine wins FDA ap­proval, with a raft of caveats

7 years ago

Man­u­fac­tur­ing is­sues hob­ble Heron's quest to mar­ket its long-act­ing non-opi­oid painkiller

7 years ago

FDA adds boxed warn­ings to in­som­nia med­i­cines fol­low­ing in­juries, deaths

7 years ago

As Mer­ck cel­e­brates ris­ing flow of Keytru­da cash, ex­ecs plot fa­cil­i­ty shut­downs, lay­offs in $1.2B re­or­ga­ni­za­tion

7 years ago

As Pralu­ent Q1 sales miss Wall Street ex­pec­ta­tions, FDA ex­pands drug's la­bel to re­flect CV risk re­duc­tion

7 years ago

Keytru­da PhI­II fail­ure in gas­tric can­cer blights Mer­ck­'s quest for front­line dom­i­nance

7 years ago
R&D

‘Some­thing needs to change’: An Al­ler­gan an­a­lyst spells out why next week’s vote could still spark a ma­jor re­vamp

7 years ago
People

DoJ ex­pands crack­down on Medicare kick­back schemes — Astel­las and Am­gen to pay near­ly $125M to re­solve al­le­ga­tions

7 years ago

Top 20 play­ers: Every­body loves an or­phan — es­pe­cial­ly when they come with block­buster sales and a long run of ex­clu­siv­i­ty

7 years ago
Cell/Gene Tx

As it takes Lartru­vo off the shelves, Lil­ly is set­ting up pro­gram to pro­vide drug ac­cess to cur­rent pa­tients

7 years ago

US sen­a­tors, ac­tivists chas­tise Gilead­'s Tru­va­da pric­ing, spot­light­ing CDC patents on drug's use as HIV pre­ven­tion pill

7 years ago

Whale watch­ing: What a decade of change at Big Phar­ma taught us about cor­po­rate phe­no­types

7 years ago
Deals
Biotech Voices

In­censed by Chi­na CRISPR scan­dal, US con­sor­tium am­pli­fy glob­al call to sus­pend hu­man em­bryo edit­ing

7 years ago
R&D

Drug dis­trib­u­tor, for­mer ex­ecs charged for fu­el­ing opi­oid cri­sis as le­gal cam­paign widens its scope

7 years ago

Anx­ious to fill Hu­mi­ra-sized rev­enue hole ahead of US patent cliff, Ab­b­Vie hits the ground run­ning with FDA ap­proval for Skyrizi

7 years ago
R&D

Te­va’s mi­graine drug can’t stop an­oth­er bad R&D headache as re­searchers scrap a failed PhI­II pro­gram for Ajovy

7 years ago
R&D

As ri­vals wait in line, Mer­ck­'s Keytru­da scores ear­ly FDA nod for front­line pa­tients with the most com­mon form of kid­ney can­cer

7 years ago
R&D

FDA ap­proves the first gener­ic for life-sav­ing opi­oid over­dose treat­ment nalox­one that can be car­ried by un­trained in­di­vid­u­als

7 years ago

In­dus­try calls for changes in two REMS guid­ances

7 years ago

For­get biosim­i­lars. Pe­ter Bach and Mark Trusheim be­lieve price con­trols are the bet­ter way to rein in bi­o­log­ics prices

7 years ago
People

Am­gen prices bone builder Eveni­ty at $21,900/year to com­pete on con­ve­nience, not cost

7 years ago

FDA tells Sprout Phar­ma, like it or not the black box on Ad­dyi stays, but we will di­lute the warn­ing

7 years ago

A block­buster cock­tail? Gilead slides No­vo Nordisk's semaglu­tide in­to new NASH triple ther­a­py

7 years ago
R&D
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