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Just shy of its 1-year an­niver­sary, ra­dio­phar­ma­ceu­ti­cals plat­form play Rayze­Bio bags an­oth­er megaround

23 hours ago
Financing

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

22 hours ago
Pharma

Start­ing fresh in man­u­fac­tur­ing, For­bion start­up re­fu­els to steer next-gen gene ther­a­py ap­proach for ALS, Alzheimer's ...

20 hours ago
Financing
Cell/Gene Tx

Aus­tralian spin­out eyes the clin­ic with a pro­phy­lac­tic nasal spray for Covid-19

15 minutes ago
Financing

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

Yesterday
R&D

An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

21 minutes ago
Financing

In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

36 minutes ago
R&D
Coronavirus

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

41 minutes ago
FDA+

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

1 hour ago
Financing

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic ...

7 hours ago
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UP­DAT­ED: Ex-FDA com­mish Stephen Hahn joins Flag­ship, a ven­ture group that spawned Covid-19 vac­cine mak­er Mod­er­na

Yesterday

‘You have to get up on the podi­um’: In­com­ing BIO chair Paul Hast­ings on di­ver­si­ty, drug pric­ing and work­ing with ...

Yesterday

Look­ing be­yond the pan­dem­ic, Mod­er­na ap­points J&J vet­er­an Paul Bur­ton as new CMO

Yesterday
Financing

An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

20 hours ago

Soft­Bank, Cor­morant lead hefty $210M in­jec­tion for Umo­ja's three-in-one can­cer im­munother­a­py play

Yesterday

Go­ing af­ter the phe­nom­e­non of 're­gR­NA,' Rick Young's Camp4 se­cures a launch round to push two pro­grams for­ward

Yesterday
Startups

A Medicxi-backed start­up looks to tack­le treat­ment-re­sis­tant blood can­cers, and it's go­ing af­ter AML first

6 days ago

A gene ther­a­py biotech is burst­ing on­to the scene with 12 pro­grams in tow. An ul­tra-rare neu­ro dis­ease is up first

6 days ago

Po­laris, Ab­b­Vie, Bay­er back Stu­art Schreiber's hunt to turn can­cer treat­ments in­to cures

Last week
Deals

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Yesterday

CRISPR Ther­a­peu­tics takes a swing at ALS gene edit­ing in dis­cov­ery deal with AAV up­start Cap­si­da

Yesterday

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing ...

2 days ago

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FDA’s Cavaz­zoni calls for ad­comms to ‘get back to the sub­stance’

Yesterday
FDA+

As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new ...

2 days ago
Financing

FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

5 days ago
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FDA dips its toe in­to the world of pa­tient-re­port­ed out­comes for can­cer tri­als

6 days ago
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UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ...

Yesterday
R&D

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

Yesterday
R&D

75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

2 days ago
FDA+
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UP­DAT­ED: Long-await­ed No­vavax PhI­II re­sults show 90.3% over­all ef­fi­ca­cy, with 100% ef­fec­tive­ness against mod­er­ate and ...

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Lega­cies: 60 bio­phar­ma pi­o­neers over 60 who helped birth a tech rev­o­lu­tion in the mak­ing

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

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

2 months ago
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Publisher's note

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

2 months ago
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Peer review See all

Jun
11

In­ter­cept re­tools C-suite with a pair of new­com­ers; Charles Ryan moves past Alzheimer's flops with an­oth­er CEO ...

Jun
4

Two months af­ter ink­ing a SPAC deal, Ren­o­va­cor taps new CMO; Cure­Vac reels in a new de­vel­op­ment chief from Mer­ck KGaA

May
28

Re­cur­sion CSO heads west for mi­ni-brain up­start; No­var­tis vet steps up to the plate as CFO for An­drew Hirsch at C4 ...

May
21

CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ...

May
14

As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO ...

Manufacturing channel feed

Yesterday

Bay­er flush­es mon­ey in­to the Nordics with $303M down pay­ment on new Finnish plant, ex­pan­sion

At the start of the year, drug gi­ant Bay­er telegraphed its in­tent to ramp up pro­duc­tion of con­tra­cep­tives to help sup­port coun­tries in need. Now, the com­pa­ny is build­ing a new plant in ...

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Re­call re­port: An­oth­er drug­mak­er is pulling its ver­sion of met­formin off shelves af­ter a car­cino­gen scare

Yesterday
FDA+

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

4 days ago
Coronavirus
latest in Manufacturing

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

5 days ago
Coronavirus

An API firm with a his­to­ry of J&J fund­ing scores a ma­jor loan to ad­vance its port­fo­lio

5 days ago
R&D

With its con­tro­ver­sial ad­u­canum­ab ap­proval in hand, Bio­gen gears up for a quick US roll­out

5 days ago
R&D

A Wash­ing­ton CMO is dou­bling its man­u­fac­tur­ing ca­pac­i­ty, less than 5 years in­to its ex­is­tence

5 days ago

Ex­e­lead inks deal to man­u­fac­ture lipid nanopar­ti­cles for Pfiz­er/BioN­Tech vac­cine

5 days ago
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4 days ago

Months af­ter FDA re­jec­tion, Sanofi touts piv­otal win for rare dis­ease drug su­tim­limab as it preps to re­file

One of the pil­lar drugs of Sanofi's $11.6 bil­lion pick­up of Biover­a­tiv hit a big set­back late last year when the FDA sent its ap­pli­ca­tion for ap­proval back. Now, as Sanofi gears up to ...

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Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

5 days ago

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

5 days ago
FDA+
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Bris­tol My­er­s' CAR-T Breyanzi busts out a win in ear­li­er-line lym­phoma, po­ten­tial­ly crack­ing open an ex­pand­ed mar­ket

5 days ago
R&D
Cell/Gene Tx

Cit­ing 'ex­ces­sive' ex­ec­u­tive com­pen­sa­tion, ad­vi­so­ry firms want a long­time Re­gen­eron board mem­ber oust­ed

6 days ago
People

UP­DATE: Will Bio­gen ever pub­lish the tri­al re­sults for its new Alzheimer’s drug?

6 days ago
FDA+

What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

6 days ago

An­a­lysts hound Bio­gen with ques­tions over Aduhelm's $56K price point as news of Alzheimer's OK rip­ples through glob­al mar­kets

Last week
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Yesterday

As­traZeneca's Covid-19 an­ti­body cock­tail miss­es the mark in pre­vent­ing symp­toms post-ex­po­sure

As the field for mon­o­clon­al an­ti­body treat­ments of Covid-19 grows more crowd­ed, As­traZeneca has an­nounced a study of its own cock­tail AZD7442 did not meet its main goal of pre­vent­ing ...

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Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment

Yesterday

In next-gen BTK bat­tle, Ab­b­Vie and J&J tout piv­otal da­ta back­ing Im­bru­vi­ca as a com­bo treat­ment

2 days ago
latest in R&D

Ver­tex and CRISPR Ther­a­peu­tics un­veil more pos­i­tive gene ther­a­py da­ta, but busul­fan again casts a shad­ow over the field

5 days ago
Cell/Gene Tx

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

5 days ago

AGC adds an­oth­er ma­jor Covid-19 vac­cine mak­er to the client list with BioN­Tech pact for plas­mid DNA

5 days ago
Manufacturing

With its eyes set on an IPO raise, In­Car­da un­rolls mid-stage da­ta back­ing in­haled ar­rhyth­mia drug

6 days ago

US to shell out $1.2B for sup­plies of Mer­ck­'s po­ten­tial Covid-19 an­tivi­ral

Last week
Coronavirus
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FDA+ channel feed

4 days ago

FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Fri­day re­leased about 10 mil­lion dos­es of J&J’s vac­cine for use, and dis­posed of an­oth­er 60 mil­lion dos­es that were man­u­fac­tured at the now-shut­tered Emer­gent BioSo­lu­tions ...

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UP­DAT­ED: A snakebit biotech re­ceives sec­ond CRL for re­for­mu­lat­ed pain med, po­ten­tial­ly putting the ki­bosh on its ...

Yesterday

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech ...

4 days ago
People
latest in FDA+

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

5 days ago

Pfiz­er rolls out next-gen pneu­mo­coc­cal vac­cine with FDA win, beat­ing Mer­ck­'s 15-va­lent can­di­date to the punch

Last week

Ad­comm mem­ber who warned about risk of ap­prov­ing Bio­gen's ad­u­canum­ab has re­signed fol­low­ing his­toric OK — re­ports

Last week
People

Covid-19 vac­cines for kids: FDA spells out ques­tions on im­muno­bridg­ing, safe­ty fol­lowup ahead of ad­comm

Last week
Coronavirus

UP­DAT­ED: FDA re­jects Google's push to add vir­tu­al ex­am for Parkin­son’s dis­ease to its smart­watch

Last week
Pharma
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