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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

2 hours ago
Cell/Gene Tx
In Focus

The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

1 hour ago
People
Biotech Voices

It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

2 hours ago
Financing

Meet Bench­ling, the lat­est uni­corn seek­ing to rev­o­lu­tion­ize the way sci­en­tists do work with the help of the cloud

32 minutes ago
Financing

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UP­DAT­ED: J&J paus­es vac­cine roll­out as feds probe rare cas­es of blood clots

Yesterday
Regulatory
Coronavirus

Covid-19 roundup: No­vavax shakes up lead­er­ship with two pro­mo­tions and de­par­ture of CFO; Mod­er­na, No­vavax shots added ...

36 minutes ago
Coronavirus

Amy­lyx to move for­ward with ALS pro­gram in Eu­rope, but FDA wants an­oth­er look; Hu­ma­cyte adds $50M in debt fi­nanc­ing

37 minutes ago
News Briefing

Launched by MIT grads, a small start­up gets $20M to back a ro­bot­ics rev­o­lu­tion in cell ther­a­py man­u­fac­tur­ing

2 hours ago
Startups
Manufacturing

An­ti-ag­ing biotech up­start plucks a drug from Am­gen's dis­card pile, piv­ot­ing from heart fail­ure to mus­cle con­di­tions

2 hours ago
Deals

For­mer head of FDA’s med­ical and sci­en­tif­ic af­fairs on Covid: ‘FDA has nev­er been test­ed like this’

3 hours ago
People
Regulatory
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People

Pankaj Bhar­ga­va was a cen­tral fig­ure in the group fash­ion­ing Gilead’s on­col­o­gy strat­e­gy. Now he’s jumped to the ...

19 hours ago

Amarin CEO John Thero pass­es ba­ton to Eu­rope com­mer­cial chief as M&A hopes con­tin­ue to de­flate

Yesterday

Pa­trizia Cavaz­zoni named per­ma­nent di­rec­tor of CDER, adding to ques­tions around where Wood­cock will end up

2 days ago
Financing

Bain dou­bles down on Tony Coles’ quest to get a late-stage Parkin­son’s drug through to mar­ket

Yesterday

Jaguar, Sean Nolan's lat­est biotech, rais­es $139M as they fol­low Taysha's foot­steps

Yesterday

Toad ven­om to treat de­pres­sion? RA Cap­i­tal wa­gers $125M on lat­est psy­che­del­ic biotech

Yesterday
Startups

Bet­ting ear­ly on an AI niche, RA Cap­i­tal seeds a young founder's quest to un­lock 'Holy Grail' tar­gets

2 weeks ago

Two Church lab vets, a se­cre­tive in­sti­tute and an Is­raeli bil­lion­aire hunt for drugs in the guts of wild an­i­mals

3 weeks ago

GV wa­gers on sea­soned team's in­tranasal 'tem­po­rary' pre­ven­ta­tive ap­proach to virus­es — with ex-Gilead CEO John ...

3 weeks ago
Deals

Eli Lil­ly seeds a well-con­nect­ed Chi­na neu­ro start­up with drugs aim­ing at where Bio­gen, Voy­ager missed

4 hours ago

Af­ter be­ing goad­ed to sell the com­pa­ny, Alex­ion's CEO set some am­bi­tious new goals for in­vestors. Then Pas­cal So­ri­ot ...

17 hours ago

Tim Lu’s gene-cir­cuit star Sen­ti signs up for a $645M dis­cov­ery al­liance with Roche sub Spark

Yesterday

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End­points ex­clu­sive: Bob Nelsen's Re­silience snags Flori­da CD­MO work­ing with the De­fense De­part­ment on Covid-19 ...

Yesterday
Deals

Gene ther­a­pies for neu­rode­gen­er­a­tive dis­eases: Pfiz­er, No­var­tis, Bio­gen and oth­ers seek more from FDA

2 days ago
Cell/Gene Tx
Regulatory

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

5 days ago
Regulatory

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

6 days ago
People
Publisher's note

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Ar­cel­lx rais­es mega-round to put con­trol­lable CAR-T in­to the clin­ic

Yesterday
Financing
R&D

In­vestors throw $189M at Flag­ship star­tup's mis­sion to 'de­code' in­ter­ac­tions be­tween T cells and anti­gens

Yesterday
Financing

UP­DAT­ED: Sage touts first win in $3B Bio­gen pact, but safe­ty pro­file, doubts over da­ta cloud road ahead

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AACR21: Eli Lil­ly blazes new trail for RET in­hibitor, gin­ning up a re­sponse in 9 sol­id tu­mor types in ear­ly da­ta

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Endpoints Standouts

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

Last week
People

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

6 days ago
People
Publisher's note

The 20(+1) un­der 40: In­side the next gen­er­a­tion of biotech lead­ers

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Special

2020’s NDA list is packed with com­mer­cial firsts — from his­toric to hap­haz­ard. Have we reached a tip­ping point?

3 months ago
Special

Peer review See all

Apr
9

John Robin­son re­cruits a small band of Ar­ray vets to kick­start dis­cov­ery at Co­gent; Syn­tim­mune co-founder takes ...

Apr
1

Cut­ting loose from Mer­ck, Mike Nal­ly is 'run­ning to­ward a great op­por­tu­ni­ty'; No­var­tis part­ner­ship in hand, BeiGene ...

Mar
26

Mer­ck keeps it in the fam­i­ly as Robert Davis hands the CFO keys to Car­o­line Litch­field; Gilead los­es Di­ana Brainard, ...

Mar
19

Gone away are the blue­bird ex­ecs as COO, CMO both leave the nest; Mike Nal­ly is lat­est ma­jor fig­ure to move on from ...

Mar
12

With Kathy High on board, AskBio makes next lead­er­ship play and se­lects Bay­er's Gu­ru Ra­ma­murthy as fi­nance chief; ...

Manufacturing channel feed

2 days ago

Sanofi un­veils $476M vac­cine plant in Sin­ga­pore, bring­ing its to­tal out­lay to $1.7B in the field for past year

Sanofi is ready to spend mon­ey on man­u­fac­tur­ing to pre­pare for the next glob­al pan­dem­ic, and they aren't be­ing shy about it. In the lat­est in a flur­ry of moves, the French drug­mak­er ...

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

5 days ago
R&D

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

5 days ago
Deals
latest in Manufacturing

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

5 days ago
Regulatory

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

6 days ago
Pharma
Regulatory

Catal­ent pledges to in­crease pro­duc­tion of Mod­er­na vac­cine at its In­di­ana fill-fin­ish plant

Last week
Deals

UP­DAT­ED: 2,400 peo­ple re­main with­out rare dis­ease drug as Take­da man­u­fac­tur­ing woes con­tin­ue

Last week
Pharma

UP­DAT­ED: Af­ter mil­lions of Covid vac­cine dos­es were botched, the feds hand con­trol of a trou­bled Emer­gent Bio fa­cil­i­ty to J&J

Last week
Coronavirus
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Pharma channel feed

20 hours ago

Fifth Cir­cuit sides with FTC in ma­jor pay-for-de­lay set­tle­ment case

The US Court of Ap­peals for the Fifth Cir­cuit on Tues­day up­held the Fed­er­al Trade Com­mis­sion’s rul­ing that gener­ic drug­mak­er Im­pax Lab­o­ra­to­ries should be charged with an­titrust vi­o­la­tions ...

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FDA dis­pens­es with in-per­son re­quire­ment for abor­tion pill ac­cess dur­ing the pan­dem­ic

Yesterday
Regulatory

Re­gen­eron’s Covid mAb as a pro­phy­lac­tic in­jec­tion: Re­duced risk of symp­to­matic in­fec­tion by 81%

2 days ago
Coronavirus
latest in Pharma

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

5 days ago
Regulatory

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

6 days ago
R&D

Se­ries of JAK in­hibitor de­lays may sig­nal an up­com­ing FDA ad­comm

6 days ago
Regulatory

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

6 days ago
R&D

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

6 days ago
Regulatory
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R&D channel feed

4 days ago

AACR21: As­traZeneca un­veils next-gen PARP in­hibitor, look­ing to fol­low up on suc­cess of first-gen suc­cess sto­ry Lyn­parza

As­traZeneca's PARP in­hibitor Lyn­parza has raced out to block­buster sales on the premise of killing tu­mor cells by in­hibit­ing their abil­i­ty to ad­e­quate­ly heal. But Lyn­parza is­n't a per­fect ...

READ MORE

'Learned a lot last year': Af­ter Covid-19 suc­cess, Mod­er­na's Stéphane Ban­cel plans to give rest of pipeline a big ...

4 hours ago

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

18 hours ago
Coronavirus
latest in R&D

Tu­mor-treat­ing elec­tric fields show ear­ly promise in NSCLC — boost­ing both Novo­cure and its Chi­nese biotech part­ner

Yesterday

Or­biMed-backed The­seus de­buts with $100M round in hero­ic quest for 'pan-vari­ant' ki­nase in­hibitors

Yesterday
Financing

AACR21: iTeos busts out ear­ly hu­man da­ta for an­ti-TIG­IT an­ti­body. Is it enough to match up with Roche, Mer­ck?

2 days ago

AACR21: Zen­tal­is keeps the heat on As­traZeneca with ear­ly WEE1 da­ta show­ing a group of 'ex­cep­tion­al' re­spon­ders

3 days ago

AACR21: AACR roundup: Ar­cus rolls out PhI da­ta on adeno­sine block­er for CRC; Co­di­ak's en­gi­neered ex­o­some for IL-12 shows ear­ly promise

4 days ago
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Regulatory channel feed

21 hours ago

Opin­ion: Biden needs to step up and nom­i­nate an FDA com­mis­sion­er

Enough with the wait­ing. Pres­i­dent Joe Biden needs to em­brace the FDA dur­ing this pan­dem­ic and kick­start the Sen­ate con­fir­ma­tion process for the next per­ma­nent com­mis­sion­er.

READ MORE

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

5 days ago
Coronavirus

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

5 days ago
latest in Regulatory

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

6 days ago
Pharma

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

6 days ago
Pharma

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

Last week
Coronavirus

FDA and EMA sig­nal an op­por­tu­ni­ty to har­mo­nize ad­vanced ther­a­py reg­u­la­tions

Last week
Cell/Gene Tx

FDA push­es eczema de­ci­sion for Eli Lil­ly's Olu­mi­ant, Pfiz­er's abroc­i­tinib back 3 months — rais­ing more ques­tions for the JAK class

Last week
Pharma
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