Te­va re­ceives CRL for re­for­mu­lat­ed schiz­o­phre­nia drug de­vel­oped with French biotech

4 years ago
R&D
FDA+

Covid-19 roundup: Poland re­fus­es to pay for more vac­cine dos­es, trig­ger­ing le­gal fight; Pfiz­er, Mod­er­na face more ...

4 years ago
Coronavirus

Flag­ship-found­ed Tessera fu­els up with $300M 'to go on a re­al­ly big ad­ven­ture' in gene edit­ing

4 years ago
Financing
Startups

Al­aba­ma set­tles for $276M with McKesson, J&J and En­do over opi­oid cri­sis

4 years ago
Pharma

FTC re­quires Hik­ma to let go of steroid drug as part of $375M ac­qui­si­tion of Custopharm

4 years ago
Deals
Pharma

Un­der new CEO Joaquin Du­a­to, J&J promis­es 's­mall, medi­um and large scale' buy­outs as spin­off nears

4 years ago
Pharma

FDA warns pe­di­atric neu­rol­o­gist for fail­ing to check el­i­gi­bil­i­ty of tri­al par­tic­i­pants

4 years ago
Pharma
FDA+

Ab­b­Vie takes next step in Ukraine, do­nat­ing all Rus­sia prof­its to re­lief

4 years ago
Pharma

FDA re­view­ers plot case for ran­dom­ized da­ta on blood can­cer PI3K in­hibitors ahead of ad­vi­so­ry meet­ing

4 years ago
Pharma
FDA+

Asahi Ka­sei ac­quires Biono­va and its shiny new Cal­i­for­nia site

4 years ago
Pharma
Manufacturing

Strug­gles with FDA con­tin­ue for Lupin as it is hand­ed an­oth­er Form 483

4 years ago
Pharma
Manufacturing

FDA lawyer digs in her heels as Mak­e­na ac­cel­er­at­ed ap­proval with­draw­al saga drags on

4 years ago
FDA+

Mar­ket­ingRx roundup: Hori­zon, Ab­b­Vie, Genen­tech land top work­place hon­ors; Pfiz­er re­ups so­cial Covid-19 push

4 years ago
Pharma
Marketing

Rid­ing on wave of clin­i­cal tri­al re­forms, ma­chine learn­ing start­up bags $50M to cre­ate 'dig­i­tal twin­s'

4 years ago
Financing
Outsourcing

Q&A: Hori­zon’s com­mer­cial chief Ke­li Wal­bert talks Te­pez­za, rare dis­ease mar­ket­ing and fam­i­ly ties

4 years ago
Pharma
Marketing

On heels of psych drug ap­proval, BioX­cel dives head first in­to on­col­o­gy R&D with new cash in­fu­sion

4 years ago
Financing

'Tim­ing could­n't be bet­ter': An ex-gener­ics mak­er goes SPAC route with blank check in­tend­ed for sports mar­ket

4 years ago
Financing
Startups

Bear mar­ket shows no signs of abat­ing, claim­ing Finch Ther­a­peu­tics as the lat­est lay­off vic­tim

4 years ago
People

Covid-19 roundup: Mod­er­na show­cas­es progress on its bi­va­lent boost­er; No­vavax wins ap­proval in Japan

4 years ago
R&D
Coronavirus

Or­biMed-backed biotech looks to chal­lenge Ver­tex in cys­tic fi­bro­sis by 'drug­ging the un­drug­gable'

4 years ago
Financing
R&D

Ex­clu­sive: En route to first xeno­trans­plan­ta­tion tri­al, eGe­n­e­sis taps new CEO weeks af­ter CMO hire

4 years ago
People
Startups

Ax­some agrees to post-mar­ket­ing com­mit­ments with FDA, sig­nal­ing po­ten­tial OK for long-de­layed de­pres­sion drug

4 years ago
FDA+

Aca­di­a's prized pain drug from $52M buy­out flops its first test

4 years ago
R&D

Re­gen­eron buys Art Krieg’s biotech start­up for a dis­count price, boost­ing I/O pipeline

4 years ago
Deals
R&D
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