Phar­ma in­dus­try spent a record $389M on US lob­by­ing in 2021, but more is like­ly com­ing this year — re­port

3 years ago
Pharma

FDA adds some fresh se­nior lead­er­ship with new chief sci­en­tist, chief med­ical of­fi­cer

3 years ago
FDA+

No­var­tis buys Mallinck­rodt's FDA vouch­er for $100M but re­mains mum on where to use its 7th PRV

3 years ago
FDA+

PI3K in­hibitor hit with an in­creased death risk warn­ing from FDA af­ter fi­nal tri­al re­sults emerge

3 years ago
FDA+

GSK se­lects ‘thought­ful’ mul­ti­ple myelo­ma pro­gram for in­au­gur­al ‘Think Tank’ chal­lenge win

3 years ago
Pharma
Marketing

New re­search ar­gues drug pric­ing ne­go­ti­a­tions would stymie in­no­va­tion, as De­moc­rats fight for re­vised pro­pos­al

3 years ago
Pharma
FDA+

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

3 years ago
FDA+
Manufacturing

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA ...

3 years ago
Manufacturing

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

3 years ago
Pharma
Manufacturing

9 Me­ters Bio­phar­ma and Cara Ther­a­peu­tics tout mid-stage da­ta for gas­troin­testi­nal, pru­ri­tus stud­ies

3 years ago
News Briefing

An­oth­er biotech grabs the axe, chop­ping R&D in a ma­jor re­or­ga­ni­za­tion as drug sales dis­ap­point

3 years ago
People
R&D

No­var­tis, BeiGene lay out front­line PhI­II da­ta for PD-1 drug as sec­ond-line PDU­FA date looms

3 years ago
R&D
China

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

3 years ago
Pharma
Marketing

Plot­ting a come­back af­ter 2016 flop, Seres to raise $100M to prep C. dif­fi­cile pro­gram for launch

3 years ago
Financing
R&D

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

3 years ago
People
Cell/Gene Tx

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

3 years ago
Financing

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

3 years ago
FDA+
Manufacturing

Lit­tle biotech makes deep cuts as it strug­gles to get nar­colep­sy drug ap­proved amid months of reg­u­la­to­ry lim­bo

3 years ago
People

As boost­er sea­son awaits, US re-ups sup­ply of Pfiz­er Covid-19 vac­cine with new $3.2B deal

3 years ago
Coronavirus

Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

3 years ago
Financing
Manufacturing

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

3 years ago
R&D
FDA+

An­gion, still reel­ing from past de­feats, scraps a PhII kid­ney dis­ease study af­ter 'un­ex­pect­ed' safe­ty event

3 years ago
R&D

Catch­ing up with Bris­tol My­ers and Mer­ck, As­traZeneca de­clares neoad­ju­vant win for PD-L1/chemo com­bo

3 years ago
R&D

Gilead scores a $33M set­tle­ment from its cam­paign against ‘colos­sal fi­nan­cial fraud’

3 years ago
Pharma
Law
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