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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

22 hours ago
Pharma
R&D

Get as much Spra­va­to as you can, Trump or­ders VA while sug­gest­ing J&J should of­fer it to vet­er­ans for free

22 hours ago
Pharma

Ver­sant-backed Chi­nook gets a $65M launch round for its dis­cov­ery quest in a resur­gent kid­ney field

23 hours ago
Discovery
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Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Yesterday
R&D

Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

4 minutes ago
China
Deals

Clear­side Bio­med­ical pre­dicts its uveitis drug will be re­ject­ed, af­ter FDA re­quests more da­ta

42 minutes ago
R&D
Regulatory

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive PhI­II for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs ...

4 hours ago
R&D
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Sir An­drew Dil­lon, NICE's first — and on­ly — chief ex­ec­u­tive to step down next year

23 hours ago

MHRA to land a new in­ter­im chief ex­ec­u­tive ahead of Brex­it

Yesterday

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

3 days ago
Startups

Finch grabs a $53M round de­signed to take their ‘break­through’ mi­cro­bio­me treat­ment through a po­ten­tial­ly piv­otal ...

Yesterday

Johns Hop­kins sci­en­tists raise $137M megaround for a trio of spin­outs look­ing to tack­le Alzheimer’s, Parkin­son’s ...

Last week

Biotech tar­get­ing rare heart mu­ta­tion with gene ther­a­py scores $11M in Se­ries A haul

Last week
Deals

Vi­en­na-based vac­cine de­vel­op­er Themis signs pact with Mer­ck for 'block­buster in­di­ca­tion'

Yesterday

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

2 days ago

On the cusp of PhI, An­gel­man-fo­cused biotech scores po­ten­tial buy­out deal from Ul­tragenyx

Last week
IPOs

Fresh from $102M haul, IGM Bio pitch­es $100M IPO as it plots first-in-hu­man tri­al of new an­ti­bod­ies

2 days ago

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

3 days ago

A bud­get biotech you like­ly nev­er heard about is set­ting a course for Wall Street with some mod­est am­bi­tions

Last week

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

2 days ago
Regulatory

Bay­er’s $240M up­front for Blue­Rock ac­qui­si­tion puts them in the high rollers club for pre­clin­i­cal biotech buy­outs

3 weeks ago
Deals
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No­var­tis' $18.5B in M&A un­der Vas Narasimhan says a lot about their care­ful — but op­por­tunis­tic — deal strat­e­gy

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What makes Hal Bar­ron tick? Look at the peo­ple he’s team­ing up with at GSK

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Eight weeks be­tween each HIV treat­ment? GSK notch­es PhI­II win as it chas­es OK for long-act­ing reg­i­men

Yesterday
R&D

SEC calls out lit­tle Ther­a­peu­tic­sMD for its in­sid­er con­tacts with an­a­lysts to boost share price, then halt rout

Yesterday
Regulatory

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Yesterday
R&D

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

2 days ago
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Peer review See all

Aug
16

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

Aug
9

Amy Bur­roughs to lead Cleave Ther­a­peu­tics; Cyn­thia Collins clinch­es Ed­i­tas CEO job amid his­toric CRISPR move

Aug
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David Apelian to steer TCR play at Pitt spin­out; Third Rock scoops Il­lu­mi­na ex­ec as CEO of can­cer de­tec­tion up­start

Jul
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Peer Re­view: Ru­bius re­cruits BD chief; Epizyme hires No­var­tis vet as CFO

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Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

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3 days ago

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least an­tic­i­pat­ed moves of the year, the FDA has re­ject­ed Sarep­ta’s ap­pli­ca­tion for an ac­cel­er­at­ed ap­proval of its Duchenne MD drug golodirsen. Com­pa­ny ex­ecs told ...

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA ...

3 days ago

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

20 hours ago
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MD­MA, now in Phase III, shows promise as a PTSD treat­ment

Yesterday

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

2 days ago

FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

2 days ago
Regulatory

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

2 days ago

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

3 days ago
Pharma
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3 days ago

UP­DAT­ED: No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabri­va Ther­a­peu­tics suf­fered a set­back af­ter the FDA re­ject­ed its an­tibi­ot­ic for com­pli­cat­ed uri­nary tract in­fec­tions — the No­var­tis spin­off has now had some bet­ter luck with ...

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I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

4 days ago

Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

6 days ago
Regulatory
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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

6 days ago

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

6 days ago

Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

Last week
People

Ail­ing Mallinck­rodt's drug for rare, life-threat­en­ing re­nal con­di­tion clears piv­otal study

Last week
R&D

FDA en­dors­es new reg­i­men for dead­ly drug-re­sis­tant tu­ber­cu­lo­sis ram­pant in de­vel­op­ing world

Last week
R&D
Regulatory
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