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FDA ad­comm votes unan­i­mous­ly in fa­vor of full ap­proval for Ei­sai's new Alzheimer's drug

22 hours ago
Pharma
FDA+

FDA wants more da­ta from Abeona Ther­a­peu­tics as it push­es for BLA

Yesterday
R&D
Cell/Gene Tx

In an­nu­al re­port, FDA de­tails how it han­dled drug short­ages in 2022

22 hours ago
Pharma
Manufacturing

Who pays the most (and least) in bio­phar­ma? We crunched me­di­an salary da­ta from 175 com­pa­nies

3 days ago
People

Latest

Ad­comm votes yes on Leqem­bi full OK; Mer­ck brings first IRA law­suit; Spe­cial: LGBTQ+ lead­ers; Best-pay­ing bio­phar­ma ...

8 hours ago
Weekly

Te­va joins fel­low phar­mas in re­strict­ing 340B dis­counts

22 hours ago
Pharma

Ei­sai cy­ber at­tack leads to in­ves­ti­ga­tion of po­ten­tial da­ta leaks amid grow­ing in­dus­try threat

23 hours ago
Pharma

Bris­tol My­ers cell ther­a­py man­u­fac­tur­ing site gets thumbs-up from FDA

Yesterday
Cell/Gene Tx
Manufacturing

Phar­ma finds TV ads are a hard habit to break. It's still putting 65% of ad dol­lars in­to TV

Yesterday
Pharma
Marketing

As­traZeneca flesh­es out piv­otal da­ta on $930M rare blood dis­or­der drug it wants to pair with Soliris, Ul­tomiris

Yesterday
R&D
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People

FDA shakes up top lead­er­ship around gener­ic drugs

2 days ago

Al­ca­mi ap­points new CEO as for­mer chief Patrick Walsh an­nounces re­tire­ment

2 days ago

CBER's Pe­ter Marks shares pan­dem­ic lessons as FDA con­tin­ues 'go­ing through the back­log'

4 days ago
Financing

Oslo biotech finds an­oth­er merg­er part­ner af­ter share­hold­ers re­ject­ed No­vem­ber of­fer

Yesterday

Lyn­dra Ther­a­peu­tics eyes $180M Se­ries D for po­ten­tial 2026 launch of once-week­ly schiz­o­phre­nia med

Yesterday

Up­stream Bio match­es first fund­ing round with an­oth­er $200M to get asth­ma drug to PhI­II

2 days ago
Startups

Bit­ter­root Bio nabs $145M Se­ries A with a plan to tack­le chal­leng­ing can­cer tar­get for heart med­i­cines

3 days ago

Ace­po­di­a's off-the-shelf cell ther­a­pies get an­oth­er $100M for on­col­o­gy tri­als

4 days ago

Ex­clu­sive: With $8M, neu­ro start­up Mod­u­lo Bio emerges to test small mol­e­cules for ALS, de­men­tia in CEO’s per­son­al ...

Last week
Deals

As­traZeneca en­lists UK Treg biotech for type 1 di­a­betes, in­flam­ma­to­ry bow­el dis­ease deal fea­tur­ing $85M up­front

Yesterday

Q2 deal ac­tiv­i­ty points to po­ten­tial 'bumper year' for phar­ma — re­port

2 days ago

Sam­sung Bi­o­log­ics se­cures $400M+ man­u­fac­tur­ing deal with Pfiz­er

2 days ago

In FocusSee all

Es­cap­ing an im­prob­a­ble up­bring­ing, Greg Ver­dine places his biggest ca­reer bets in drug­ging the ‘un­drug­gable’

5 days ago
People

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more ...

3 weeks ago
Cell/Gene Tx

Fam­i­lies raised mil­lions and hand­ed rare dis­ease ther­a­pies off to biotechs. But com­pa­nies have backed out

4 weeks ago
R&D

CAR-T re­shaped can­cer treat­ment. Can it change au­toim­mune dis­ease, too?

Last month
Cell/Gene Tx

Endpoints Standouts

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

2 months ago
R&D
Special

A ra­dioac­tive prostate can­cer ther­a­py is a last life­line for pa­tients. No­var­tis can't make enough of it

3 months ago
R&D
In Focus

The top 100 biotech VCs: Who's stay­ing at the ta­ble and what do they want now?

3 months ago
Financing
Deals

#JPM23: Is 2023 go­ing to be a bet­ter year for biotech deal­mak­ing?

4 months ago

Peer review See all

Jun
9

Chemomab changes CEOs, sus­pends mid-stage tri­al; Ex-FDA vac­cine of­fi­cial lends more help to Mesoblast

Jun
2

Ex­clu­sive: Affi­ni-T taps Sanofi alum to lead hunt for part­ner­ships; Alk­er­mes locks in CEO for on­col­o­gy spin­out

May
26

Stephen Hahn’s can­cer-test­ing biotech hires a new CMO; For­mer Io­vance ex­ec named CEO of Ob­sid­i­an

May
19

Vir en­lists J&J vet to run busi­ness de­vel­op­ment; Gilead finds Kite suc­ces­sor to Christi Shaw

May
12

Astel­las pres­i­dent jumps to a new Fron­tier; Gri­fols chair­man named CEO, break­ing fam­i­ly tra­di­tion

Pharma channel feed

Yesterday

Sec­ond round of in­fla­tion-re­lat­ed re­bates hits 43 drugs from Am­gen, Seagen, Ab­b­Vie and oth­ers

The De­part­ment of Health and Hu­man Ser­vices on Fri­day re­vealed its lat­est round of coin­sur­ance sav­ings for se­niors on drugs with prices ris­ing faster than the rate of in­fla­tion.

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San­doz an­tic­i­pates ad­di­tion­al $3B in po­ten­tial net sales over five years in pipeline ex­pan­sion

Yesterday

Tiny biotech takes on mR­NA vac­cine jug­ger­nauts in fed­er­al court in patent in­fringe­ment cas­es

2 days ago
Law
latest in Pharma

FDA shuts down Intar­ci­a's re­quests to de­vi­ate from typ­i­cal post-CRL hear­ing process

3 days ago

Fo­s­un Phar­ma to re­ceive $100M+ via World Bank for fa­cil­i­ty in Ivory Coast

3 days ago
China
Manufacturing

FDA com­mis­sion­er says drug prices are too high, calls for bet­ter ev­i­dence gen­er­a­tion

3 days ago
FDA+

Up­dat­ed: FDA sig­nals like­ly full ap­proval for Ei­sai's new Alzheimer's drug ahead of Fri­day's ad­comm

3 days ago
FDA+

As­traZeneca, Sanofi's RSV an­ti­body set for FDA ad­comm on Thurs­day

3 days ago
FDA+
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Marketing channel feed

Yesterday

Amid AD­HD drug short­age, Ak­ili aims for adults with over-the-counter video game treat­ment

Ak­ili In­ter­ac­tive's launch of an over-the-counter ver­sion of its video game treat­ment ar­rives at a time when many peo­ple with AD­HD are strug­gling to get ac­cess to Adder­all and re­lat­ed ...

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No­var­tis joins the film fes­ti­val cir­cuit with doc­u­men­tary se­ries on mis­un­der­stood skin dis­ease

2 days ago
Pharma

Health eq­ui­ty coali­tion led by AMA tags phar­ma part­ners for co­or­di­nat­ed ac­tion

3 days ago
Pharma
latest in Marketing

Young mul­ti­ple scle­ro­sis pa­tients pro­fess love — for fam­i­ly, trav­el, life and more — in new No­var­tis cam­paign

3 days ago
Pharma

Phar­ma mar­keters stand 'loud­ly and proud­ly' with LGBTQ+ com­mu­ni­ty dur­ing Pride Month, de­spite boy­cotts in oth­er in­dus­tries

4 days ago
Pharma

Mar­ket­ingRx roundup: AS­CO con­fer­ence spot­lights can­cer cam­paign; Hori­zon, AZ lead Clio Health award wins

4 days ago
Pharma

GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

Last week
Pharma

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Last week
Pharma
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FDA+ channel feed

Yesterday

FDA sets De­cem­ber ap­proval de­ci­sion for first CRISPR ther­a­py, with 94% of pa­tients free of sick­le cell crises

Near­ly 11 years ago, sci­en­tists pro­grammed a pair of mol­e­c­u­lar scis­sors to make pre­cise cuts in DNA. That first test tube ex­per­i­ment of CRISPR gene edit­ing tech­nol­o­gy won its cre­ators a ...

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FDA ad­comm votes unan­i­mous­ly in fa­vor of As­traZeneca's pre­ven­tive mAb for RSV in in­fants

Yesterday

FDA ac­cepts an­oth­er sBLA for Mer­ck­'s Keytru­da, fol­low­ing Imfinzi in bil­iary tract can­cer

2 days ago
latest in FDA+

FDA to im­port ver­sions of com­mon can­cer drug to al­le­vi­ate short­age

4 days ago
Pharma
Manufacturing

Up­dat­ed: FDA pulls paid Ei­sai con­sul­tant from tem­po­rary role on ad­comm re­view­ing Ei­sai's new Alzheimer's drug

5 days ago

As­traZeneca moves ear­ly for full ap­proval with an­ti­co­ag­u­lant re­ver­sal drug An­dexxa af­ter pos­i­tive PhIV da­ta

5 days ago
R&D

FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

Last week
R&D

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

Last week
Pharma
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Manufacturing channel feed

2 days ago

Man­u­fac­tur­ing roundup: Eu­roAPI to in­vest $50M+ in Hun­gary site; WuXi to ex­pand Ger­man fa­cil­i­ty

Ac­tive phar­ma­ceu­ti­cal in­gre­di­ent man­u­fac­tur­er Eu­roAPI is look­ing to make a €50 mil­lion ($53.4 mil­lion) in­vest­ment in­to boost­ing pro­duc­tion at its fa­cil­i­ty in Bu­dapest, Hun­gary.

READ MORE

Eco­lab di­vi­sion Puro­lite will in­vest $190M to con­struct new resin pro­duc­tion fa­cil­i­ty

2 days ago

Sen­a­tor Ron Wyden press­es FDA and DEA on gener­ic Adder­all short­age

3 days ago
Pharma
latest in Manufacturing

Sam­sung Bi­o­log­ics moves up plans to open its $1.5B+ plant

3 days ago

Cana­di­an CD­MO se­cures more fund­ing to get its man­u­fac­tur­ing site up and run­ning

Last week
Financing

3M to make $146M in­vest­ment in­to pro­duc­ing bio­phar­ma tech­nol­o­gy

Last week

Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Last week
People

Man­u­fac­tur­ing roundup: Astel­las to sell Dutch fa­cil­i­ty to Del­pharm; Au­ri­gene in­vest­ing $40M in­to In­dia man­u­fac­tur­ing fa­cil­i­ty

Last week
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