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AACR: Ger­many's small NK cell play­er Af­fimed makes a big splash with ear­ly lym­phoma da­ta

5 years ago
R&D

The num­bers are in, and new Ver­tex CEO Resh­ma Ke­wal­ra­mani took home half of what pre­de­ces­sor Jeff Lei­den did in his ...

5 years ago
People

Can he pick them? A high-pro­file Wall Street an­a­lyst jumps in­to biotech as CFO of an on­col­o­gy up­start

5 years ago
People
Bioregnum

Seat­tle-based Remiges Ven­tures to launch in­cu­ba­tor af­ter heavy in­vest­ment from Japan; Schrödinger signs lease on new ...

5 years ago
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EMA in­ves­ti­gat­ing 4 'se­ri­ous cas­es' of blood clots fol­low­ing J&J vac­ci­na­tions

5 years ago
FDA+
Coronavirus

Covid-19 roundup: Lil­ly/In­cyte's Olu­mi­ant plus remde­sivir com­bo whiffs PhI­II; France rec­om­mends mix­ing vac­cines among ...

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Coronavirus

CBO: Con­gres­sion­al ac­tion on drug prices will make R&D spend­ing less at­trac­tive

5 years ago
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FDA+

MPM-backed Were­wolf, Mer­ck-part­nered Arti­va make quick IPO flip while Lu­ca Santarel­li's biotech rais­es $127.5M

5 years ago
Financing

Scoop: Fer­ring, Black­stone’s $570M gene ther­a­py ven­ture has im­plod­ed af­ter CMC is­sues stymied a once high-pro­file ...

5 years ago
FDA+
Manufacturing

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

5 years ago
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Pharma

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

5 years ago
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FDA+

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

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

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

5 years ago
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FDA+
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