Trou­ble brew­ing for Proven­tion? Shares crater af­ter FDA says their teplizum­ab drug pro­file does­n't match that from ...

5 years ago
FDA+

Man­u­fac­tur­ing brief­ing: Af­ter J&J-Emer­gent mix­up, few­er dos­es ex­pect­ed in US next week; Boehringer taps Ox­ford for ...

5 years ago
R&D
Manufacturing

CD­MO Ster­ling ac­quires ADC Bio, ramp­ing up ca­pac­i­ty for an­ti­body-drug con­ju­gate man­u­fac­tur­ing work

5 years ago
Deals
Manufacturing

FDA in­spec­tion of Emer­gent’s Bal­ti­more site in 2020 rais­es new ques­tions

5 years ago
FDA+
Manufacturing

Valen­z­aBio's on­col­o­gy is­land of mis­fit toys snares $70M af­ter toil­ing be­hind the scenes for months

5 years ago
Financing

Bio­gen ac­quires rights for po­ten­tial Actem­ra biosim­i­lar; Roy­al­ty Phar­ma buys lumasir­an roy­al­ty stream for up to $240M

5 years ago
News Briefing

Bris­tol My­er­s' Op­di­vo notch­es a dou­ble win against chemo in esophageal can­cer, po­ten­tial­ly set­ting up 1st-line nod

5 years ago
R&D
Pharma

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

5 years ago
Pharma
FDA+

Look­ing to re­bound from re­jec­tion in TNBC, Mer­ck­'s Keytru­da pass­es a new kid­ney can­cer test

5 years ago
R&D
Pharma

For­mer In­di­v­ior med­ical lead who pled guilty to false opi­oid mar­ket­ing now seeks FDA hear­ing to es­cape de­bar­ment

5 years ago
Pharma
FDA+

The CHIC in­ter­view: Stéphane Ban­cel on Mod­er­na's overnight trans­for­ma­tion, the new time­line on vac­cine de­vel­op­ment ...

5 years ago
People
Publisher's note

Re­call re­port: A-S pulls near­ly 200,000 ac­eta­minophen bot­tles off shelves; Apo­tex yanks AD­HD med

5 years ago
Pharma
FDA+

Fe­male en­tre­pre­neurs have long been un­der­rep­re­sent­ed in biotech. An MIT team de­cid­ed to find out why

5 years ago
People
Financing

Covid-19 roundup: BeiGene's re­pur­posed BTK in­hibitor flops in PhII tri­al; Philip­pines sus­pends As­traZeneca's vac­cine ...

5 years ago
Coronavirus

PDU­FA VII ne­go­ti­a­tions near fin­ish line with plans to re­vamp CBER and staff up

5 years ago
Pharma
FDA+

Eli Cas­din and Kei­th Meis­ter dive back in­to the SPAC well with $480M haul just weeks af­ter So­ma­Log­ic re­verse merg­er

5 years ago
Financing

Eye­ing stan­dard of care sta­tus in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slight­ly broad­er la­bel

5 years ago
Pharma
FDA+

Ver­sant-backed Ven­tus scores $100M round to tur­bocharge its dual-plat­form play at 'drug­ging the un­drug­gable'

5 years ago
Financing

Am­gen CEO Bob Brad­way takes home $20M+ pay pack­age amid bang-up year for sales

5 years ago
People

The End­points 100 sur­vey: CEOs changed the way biotechs op­er­ate dur­ing the pan­dem­ic. Things will nev­er be the same ...

5 years ago
People
Special

Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al ...

5 years ago
News Briefing

EMA finds link be­tween ‘very rare’ but some­times fa­tal blood clots and As­traZeneca vac­cine

5 years ago
FDA+
Coronavirus

The con­tin­u­ing CRISPR patent saga

5 years ago
Biotech Voices

FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

5 years ago
Cell/Gene Tx
FDA+
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