Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

3 years ago
FDA+

Big Phar­ma's Twit­ter ex­o­dus; Mer­ck wa­gers $1.35B on buy­out; $3.5M gene ther­a­py; and more

3 years ago
Weekly

MIT re­searchers re­veal DNA 'Paste' tech be­hind lat­est gene edit­ing start­up

3 years ago
Discovery
Cell/Gene Tx

J&J's Spra­va­to pulls a PhI­II win against Sero­quel XR in treat­ment-re­sis­tant de­pres­sion

3 years ago
R&D

Sus­pend­ed Cal­i­for­nia cell ther­a­py man­u­fac­tur­ing site hit with FDA warn­ing let­ter over ma­jor qual­i­ty con­cerns

3 years ago
Pharma
FDA+

Roivant’s Der­ma­vant de­buts first-ever TV com­mer­cial for pso­ri­a­sis cream Vta­ma

3 years ago
Pharma
Marketing

Phar­ma re­new­able en­er­gy co-op sparks broad­er sup­pli­er push, fol­lows Wal­mart's lead

3 years ago
Pharma
Marketing

FDA preps for DMD drug gener­ics as Sarep­ta has yet to fin­ish its con­fir­ma­to­ry tri­al

3 years ago
Pharma
FDA+

Gam­ing for phar­ma: Re­al Chem­istry adds video game mar­ket­ing to agency ex­per­tise

3 years ago
Pharma
Marketing

One hur­dle down? FDA won't hold ad­comm for Bio­Mar­in's he­mo­phil­ia gene ther­a­py af­ter all

3 years ago
Cell/Gene Tx

FDA push­es back Gami­da Cell’s PDU­FA date by three months

3 years ago
R&D

No­var­tis to ad­vance malar­ia pro­gram in­to PhI­II in bid to fight drug re­sis­tance

3 years ago
R&D

Mi­rati gaug­ing sale in­ter­est of Big Phar­mas — re­port

3 years ago
Deals

Scoop: Ver­sant, NEA launch new biotech helmed by ex-CEO of pro­tein de­grad­er C4 Ther­a­peu­tics

3 years ago
Financing
Startups

Ox­ford Bio­med­ica's next CEO to start in March; Kåre Schultz ready to wrap up Te­va tenure ear­ly

3 years ago
Peer Review

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

3 years ago
Cell/Gene Tx
FDA+

Sh­ionogi's Covid an­tivi­ral lands first ap­proval in Japan's new emer­gency ap­proval path­way

3 years ago
R&D
Coronavirus

No­vo Nordisk to spend $747M+ on ex­pan­sions and new fa­cil­i­ty in Den­mark

3 years ago
Pharma
Manufacturing

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

3 years ago
Pharma
Coronavirus

The ac­cel­er­at­ed ap­proval path­way is evolv­ing in plain sight, with or with­out con­gres­sion­al help

3 years ago
FDA+

Mer­ck scores an­oth­er win for King Keytru­da, this time in HER2-neg­a­tive can­cer

3 years ago
R&D
Pharma

Fu­ji­film to build $188M man­u­fac­tur­ing plant in North Car­oli­na’s re­search tri­an­gle

3 years ago
Pharma
Manufacturing

Phar­ma rep­u­ta­tion falls again, notch­ing dou­ble-dig­it down­turn over past year in US — sur­vey

3 years ago
Pharma
Marketing

Mar­ket­ingRx roundup: Am­gen and Sto­ryCorps launch health eq­ui­ty se­ries; Ab­b­Vie's $40M math and sci­ence school opens

3 years ago
Pharma
Marketing
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