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

3 days ago
Cell/Gene Tx

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

4 days ago
Cell/Gene Tx
FDA+

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

3 days ago
R&D

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

Yesterday
Weekly

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

2 days ago
Discovery
Cell/Gene Tx

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

3 days ago
R&D

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

3 days ago
Pharma
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Cy­cle­ri­on board quick­ly nix­es CEO Pe­ter Hecht's un­ortho­dox pitch for low cash re­serves

4 days ago

Up­dat­ed: Te­va picks for­mer San­doz head as new CEO to re­place Kåre Schultz

6 days ago

Gun­ning for first chikun­gun­ya vac­cine OK, Val­ne­va raids GSK for a sea­soned com­mer­cial chief

Last week
Financing

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

4 days ago

Ger­man biotech CatalYm rais­es $50M to flip weight loss tar­get for can­cer

4 days ago

Sim­u­la­tions for ex­per­i­ments: Bay­er-backed start­up lands $20M to test out its tech

5 days ago
Startups

Mak­er of new gene ther­a­py vec­tor launch­es its sec­ond com­pa­ny, look­ing to ze­ro in on rare skin con­di­tions

5 days ago

With the clin­ic in sight, Greg Verdine's start­up bags $178M for new class of tar­get­ed ther­a­pies

5 days ago

Plexxikon vets kick off new drug dis­cov­ery out­fit — with old as­sets and new tar­get

6 days ago
Deals

Mi­rati gaug­ing sale in­ter­est of Big Phar­mas — re­port

3 days ago

Ob­sE­va, des­per­ate for cash, sells rights to PhII drug in bid to ex­tend run­way, test new preg­nan­cy can­di­date

4 days ago

Af­ter Chi­nese CD­MO fails, Cam­brex ac­quires in­gre­di­ent man­u­fac­tur­er Snap­drag­on Chem­istry

5 days ago

Premium storiesSee all

Twit­ter ad­ver­tis­ing pause or per­sist? Phar­mas qui­et­ly weigh op­tions in un­cer­tain time

3 weeks ago
Pharma
Marketing

By the num­bers: As the pan­dem­ic biotech boom fades, it's be­gin­ning to look a lot like 2019 — or be­fore

3 weeks ago
Deals

Al­tos Labs founders Bar­ron and Klaus­ner: 'There are mech­a­nisms in the cell where you can re­set not the stress curve, ...

3 weeks ago
R&D

Scoop: A Soft­Bank-backed biotech rais­es more funds af­ter bag­ging $100M+ for fun­gi min­ing

3 weeks ago
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In FocusSee all

Covid-19 spurred a his­toric vac­cine R&D ef­fort. What does it mean for fu­ture pan­demics?

4 weeks ago
R&D
Coronavirus

A biotech paused a gene ther­a­py hatched by fam­i­lies. Now they want con­trol

Last month
Cell/Gene Tx

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Last month
People
Pharma

Even as pan­dem­ic re­cedes, short-staffed tri­al sites leave can­cer pa­tients wait­ing

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

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

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

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

4 days ago
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Endpoints Standouts

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

6 months ago
People
Discovery

The 20(+1) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

7 months ago
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The 2022 top 100 bio­phar­ma in­vestors: A look back on boom times

9 months ago
Financing
Deals

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

11 months ago
People
Special

Peer review See all

Nov
23

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

Nov
18

Ex-Ru­bius CEO dusts him­self off at a dif­fer­ent Flag­ship biotech; Hutchmed switch­es things up dur­ing pipeline re­fo­cus

Nov
11

Fourth time's the charm? blue­bird picks up new fi­nance chief; New CEOs here and there

Nov
4

Af­ter a one-year gap, Sage fi­nal­ly finds new CMO; Gut­ted by lay­offs, Flag­ship's Ru­bius reshuf­fles a not-so-full deck

Oct
28

Two Au­rinia ex­ecs are out — and CRISPR’s op­er­a­tions chief is­n't far be­hind; Bio­gen MS leader jumps to Eli Lil­ly ...

Pharma channel feed

6 days ago

Up­dat­ed: No Seagen here: 'Do more' means a small $1.35B pur­chase of Ima­go for Mer­ck

Mer­ck is mak­ing an ac­qui­si­tion, the Big Phar­ma an­nounced be­fore Mon­day’s open­ing bell. No, Seagen is not en­ter­ing the fold, as had been spec­u­lat­ed for quar­ters.

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

3 days ago
FDA+

No­vavax pulls out of Covid-19 vac­cine al­liance with Gavi

4 days ago
Coronavirus
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No­vo Nordisk to spend $747M+ on ex­pan­sions and new fa­cil­i­ty in Den­mark

4 days ago
Manufacturing

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

4 days ago
R&D

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

4 days ago
Manufacturing

Days af­ter re­port­ing PhI­II fail­ure, GSK pulls BC­MA drug from US mar­ket — but it's not giv­ing up en­tire­ly yet

5 days ago
FDA+

Eli Lil­ly to dou­ble its man­u­fac­tur­ing ca­pac­i­ty for Moun­jaro as it faces fi­nan­cial head­winds go­ing in­to 2023 — re­port

5 days ago
Manufacturing
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Marketing channel feed

5 days ago

Biggest drug com­pa­nies halt­ed Twit­ter ad buys af­ter Lil­ly in­sulin spoof

Al­most all of the drug in­dus­try's biggest ad­ver­tis­ers cut their spend­ing on Twit­ter to ze­ro or near-ze­ro over the last two weeks amid wor­ries about im­per­son­ation of their brands by ...

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

4 days ago
Pharma

Take­da goes back to school, team­ing up with Dis­cov­ery Ed­u­ca­tion for health eq­ui­ty ini­tia­tive

5 days ago
Pharma
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Rare in com­mon: Health Union's newest so­cial com­mu­ni­ty aims to con­nect across rare dis­eases

5 days ago
Pharma

Vi­iV takes to the couch for con­ver­sa­tions about HIV in its new ‘Sci­ence on the So­fa’ se­ries

Last week
Pharma

Pre­dic­tive mar­ket­ing moves in­to elec­tron­ic health records, tar­get­ing doc­tors at ex­act points of care

Last week
Pharma

GSK once again tops drug ac­ces­si­bil­i­ty rank­ing, with J&J and As­traZeneca close be­hind

Last week
Pharma

Ecom­merce mar­ket­ing for phar­ma? Agency adds new spe­cial­ty unit with eye to fu­ture

Last week
Pharma
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FDA+ channel feed

4 days ago

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

FDA lead­ers have made clear that re­form­ing the ac­cel­er­at­ed ap­proval path­way is a pri­or­i­ty, and with sev­er­al re­cent ac­tions, the agency has sig­naled that it's will­ing to take ac­tion on those ...

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An­ti-abor­tion groups file suit against FDA in Texas, de­mands agency re­voke ap­proval for abor­tion pill

5 days ago
Law

FDA hits Io­vance with one more de­lay for TIL ther­a­py, ex­tend­ing BLA fil­ing un­til 2023

Last week
Cell/Gene Tx
latest in FDA+

Up­dat­ed: Proven­tion prices drug to de­lay type I di­a­betes at $193K as FDA nod kicks off US launch with Sanofi

Last week

Take­da touts pos­i­tive first-line leukemia re­sults — but is­n't quite ready to re­veal the hard da­ta

Last week
Pharma

Lil­ly wins FDA ap­proval for sec­ond in­ter­change­able in­sulin biosim­i­lar

Last week
Pharma

FDA lead­ers Califf and Paz­dur dish on ac­cel­er­at­ed ap­proval re­forms, sin­gle-coun­try tri­als and an emp­ty White Oak

Last week

Up­dat­ed: In sur­prise turn, FDA ad­comm votes in fa­vor of Arde­lyx CKD drug de­spite agency ques­tions

Last week
Pharma
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Manufacturing channel feed

Last week

Ra­dioiso­tope com­pa­ny moves for­ward with CD­MO plans, break­ing ground on new man­u­fac­tur­ing site in Wis­con­sin

As the ra­dio­phar­ma­ceu­ti­cal mar­ket has been at­tract­ing a healthy amount of at­ten­tion and cap­i­tal, one com­pa­ny is look­ing to plant its flag in the pro­duc­tion of ra­dioiso­topes for use in ...

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Man­u­fac­tur­ing roundup: Cel­l­Vax part­ners up with Ther­a­gent for PhII tri­al; Ox­ford Bio­med­ica sells fa­cil­i­ty for $70M+

Last week

Emer­gent scores a DoD award to eval­u­ate its chikun­gun­ya vac­cine in the field

Last week
Financing
latest in Manufacturing

Mer­ck KGaA’s Mil­li­pore­Sig­ma in­vests $286M to build out biosafe­ty test­ing

Last week
Pharma

Drug­mak­er fined by Span­ish reg­u­la­tors $10M for 'ex­ces­sive price' of rare dis­ease drug

Last week
Pharma
Law

Pri­vate in­vest­ment firm snaps up Pfiz­er fa­cil­i­ty in West­ern Aus­tralia

Last week
Deals

BioN­Tech ac­quires a for­mer No­var­tis man­u­fac­tur­ing fa­cil­i­ty in Sin­ga­pore

Last week
Pharma

Io­n­is part­ners up with Metageno­mi on drug dis­cov­ery pact, shelling out $80M up­front

Last week
Deals
R&D
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