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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

Yesterday

Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

16 hours ago
Weekly

US gov­ern­ment more than dou­bles the sup­ply of mon­key­pox vac­cine

Yesterday
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Manufacturing

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Yesterday
Pharma
Marketing

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FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

2 days ago
R&D
FDA+

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Yesterday
Financing
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Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Yesterday
Pharma
Marketing

What’s been on in­flu­en­tial on­col­o­gist­s' minds? Most­ly AS­CO, but al­so health eq­ui­ty, ac­cord­ing to new Har­ris Poll ...

Yesterday
Pharma
Marketing

No­var­tis to de­cide on spin­ning off $25B gener­ics arm San­doz by year's end

Yesterday
Pharma

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Yesterday
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An­oth­er biotech grabs the axe, chop­ping R&D in a ma­jor re­or­ga­ni­za­tion as drug sales dis­ap­point

2 days ago

Scoop: A small gene ther­a­py biotech, flush with ex-Sarep­ta and blue­bird lead­ers, guts CMC

2 days ago

Lit­tle biotech makes deep cuts as it strug­gles to get nar­colep­sy drug ap­proved amid months of reg­u­la­to­ry lim­bo

2 days ago
Financing

Small Mass­a­chu­setts biotech tries to beat back the bears with $55M PIPE

Yesterday

With chance to take on Bris­tol My­er­s' $13B heart drug, Cy­to­ki­net­ics preps for piv­otal stud­ies with $450M debt raise

Yesterday

Plot­ting a come­back af­ter 2016 flop, Seres to raise $100M to prep C. dif­fi­cile pro­gram for launch

2 days ago
Startups

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

3 days ago

Ox­ford spin­out nabs al­most $100M in new cash to test PD-1 in au­toim­mune dis­eases and hunt for a CEO

3 days ago

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

4 days ago
Deals

Ot­su­ka pays Ake­bia $55M to for­mal­ly end vadadu­s­tat part­ner­ship, wav­ing good­bye to the $1B deal

Yesterday

Am­gen sells its Turk­ish man­u­fac­tur­ing arm for $135M

3 days ago

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

3 days ago

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

4 days ago
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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

5 days ago
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Con­gress lays out its de­mands for FDA in 2023 — on every­thing from ma­chine learn­ing to im­munother­a­pies

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A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

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

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Is this Sil­i­con Val­ley duo the fu­ture of biotech?

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Can this tick bi­ol­o­gist and her team of ‘weirdo sci­ence’ en­thu­si­asts change the fu­ture of sci­en­tif­ic re­search?

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En­do adds to a pile­up of bad news as lead drug flunks PhII study

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Bay­er's re­search and de­vel­op­ment teams set­tle in­to new, $140M Kendall Square digs

Yesterday
R&D
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Proven­tion's sec­ond shot at FDA ap­proval for di­a­betes pre­ven­tion drug hits new hur­dle

Yesterday
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Tak­ing aim at Xo­lair, Celldex of­fers a pos­i­tive ear­ly read­out for their ri­val drug — but re­searchers have a lot of ...

Yesterday
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Endpoints Standouts

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

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

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

6 months ago
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Peer review See all

Jul
1

Swat­ting away a takeover at­tempt, Zymeworks keeps re­tool­ing staff; Af­ter Cyg­nal-ing her ex­it from Flag­ship, Pearl ...

Jun
24

Af­ter sev­en months of search­ing, Lan­dos hires a CEO; Mar­ty Du­vall re-emerges from ill-fat­ed On­copep­tides tenure

Jun
17

As law­suit car­ries on against Guardant Health, CFO shake­up hits Il­lu­mi­na; Pfiz­er-backed biotech taps CEO to lead ...

Jun
10

Amarin fish­es for an­oth­er CFO as down­siz­ing takes hold; Cure­Vac makes a deal, then lines up No­var­tis ex­ec to lead ...

Jun
3

Time Pas­sages: Bruce Gold­smith out at Jim Wilson's gene ther­a­py biotech; Flag­ship re­veals Michael Sev­eri­no’s CEO ...

Pharma channel feed

2 days ago

No­var­tis to re­sume the pro­duc­tion of two ra­di­oli­gand ther­a­pies af­ter re­solv­ing qual­i­ty is­sues

Ear­li­er this year, No­var­tis tout­ed its ra­di­oli­gand as a ma­jor piece to counter com­pe­ti­tion in the can­cer space. How­ev­er, the phys­i­cal pro­duc­tion of its prod­ucts has had any­thing but a ...

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Gilead scores a $33M set­tle­ment from its cam­paign against ‘colos­sal fi­nan­cial fraud’

3 days ago
Law

Vedan­ta opens man­u­fac­tur­ing fa­cil­i­ty to pro­duce lead can­di­date as it heads for PhI­II

3 days ago
Manufacturing
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Phar­ma in­dus­try spent a record $389M on US lob­by­ing in 2021, but more is like­ly com­ing this year — re­port

2 days ago

New re­search ar­gues drug pric­ing ne­go­ti­a­tions would stymie in­no­va­tion, as De­moc­rats fight for re­vised pro­pos­al

2 days ago
FDA+

No­var­tis, BeiGene lay out front­line PhI­II da­ta for PD-1 drug as sec­ond-line PDU­FA date looms

2 days ago
R&D
China

HHS to dis­trib­ute 1.6M mon­key­pox vac­cine dos­es this year

3 days ago

Eu­ro­pean Com­mis­sion says it does­n't have texts be­tween pres­i­dent Ur­su­la von der Leyen and Pfiz­er CEO Al­bert Bourla

3 days ago
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Marketing channel feed

2 days ago

Roche, Pfiz­er top list of ESG lead­ers in pa­tient group­s' view, but many still think phar­mas can do bet­ter

The rise of phar­ma en­vi­ron­men­tal, so­cial and gov­er­nance (ESG) ef­forts in the past two years has been me­te­oric as in­vestors turn their at­ten­tion to sus­tain­able fund­ing. How­ev­er, in­vestors ...

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#Can­nes­Lions2022: Con­sumer health ex­ecs call on agen­cies to in­volve pa­tients in cre­ative process

4 days ago
Pharma

#Can­nes­Lions2022 Mar­ket­ingRx roundup: Phar­ma and health fi­nal­ists packed in back of Palais base­ment dis­plays; Ryan ...

4 days ago
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GSK se­lects ‘thought­ful’ mul­ti­ple myelo­ma pro­gram for in­au­gur­al ‘Think Tank’ chal­lenge win

2 days ago
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#Can­nes­Lions2022: Phar­ma and health mar­keters lose spot­light at cre­ativ­i­ty ad fest, but does it mat­ter?

4 days ago
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#Can­nes­Lions2022: Di­ver­si­ty, eq­ui­ty and in­clu­sion takes cen­ter stage as phar­ma in­dus­try is called to ac­tion

4 days ago
Pharma

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

Last week
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#Can­nes­Lions2022: Mar­ket­ing lead­ers stress im­por­tance of em­pa­thy in da­ta use

Last week
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FDA+ channel feed

2 days ago

ICM­RA to launch sev­er­al reg­u­la­to­ry pi­lot pro­grams cen­tered around man­u­fac­tur­ing in­spec­tions

As reg­u­la­to­ry agen­cies look to catch up on in­spec­tions amid the Covid-19 pan­dem­ic, ICM­RA is un­veil­ing sev­er­al pi­lot pro­grams to ad­dress in­dus­try ap­pli­ca­tions and in­spec­tions.

READ MORE

FDA slaps warn­ing let­ter on Min­neso­ta API fa­cil­i­ty af­ter em­ploy­ee de­stroys clean­ing log

2 days ago
Manufacturing

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

4 days ago
Pharma
Manufacturing
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Covid-19 roundup: Ox­ford Bio­med­ica and As­traZeneca ex­tend vac­cine deal; FDA wants boost­ers for new­er vari­ants

Yesterday
Coronavirus

FDA adds some fresh se­nior lead­er­ship with new chief sci­en­tist, chief med­ical of­fi­cer

2 days ago

No­var­tis buys Mallinck­rodt's FDA vouch­er for $100M but re­mains mum on where to use its 7th PRV

2 days ago

PI3K in­hibitor hit with an in­creased death risk warn­ing from FDA af­ter fi­nal tri­al re­sults emerge

2 days ago

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

3 days ago
Coronavirus
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Manufacturing channel feed

2 days ago

Man­u­fac­tur­ing roundup: Teru­mo BCT part­ners with Bio­Bridge sub­sidiary to man­u­fac­ture cell and gene ther­a­pies; WuXi STA opens plant for HPA­PI pro­duc­tion

As the man­u­fac­tur­ing of cell and gene ther­a­pies is ramp­ing up and com­pa­nies are start­ing to in­vest in their man­u­fac­tur­ing ca­pa­bil­i­ties, Teru­mo Blood and Cell Tech­nolo­gies have formed a ...

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Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

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Charles Riv­er Lab­o­ra­to­ries to start cell and gene ther­a­py man­u­fac­tur­ing at UK site in Sep­tem­ber

4 days ago
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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

5 days ago
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Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

5 days ago
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EU to launch vac­cine de­vel­op­ment and man­u­fac­tur­ing part­ner­ship with Latin Amer­i­can and Caribbean coun­tries

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Man­u­fac­tur­ing roundup: GSK opens a new fa­cil­i­ty at Barnard Cas­tle lo­ca­tion; Tenaya Ther­a­peu­tics com­pletes build­out of Bay Area ge­net­ic med­i­cine man­u­fac­tur­ing site

Last week

FDA warns Mex­i­can glyc­erin man­u­fac­tur­er for re­fus­ing an in­spec­tion

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