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On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

30 minutes ago
Regulatory
Coronavirus

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

2 hours ago
Deals
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Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial ...

4 hours ago
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With lumasir­an on the FDA's doorstep, Al­ny­lam reads out new PhI­II da­ta in PH1

18 minutes ago
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UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Yesterday
R&D

News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

53 minutes ago
News Briefing

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

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Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

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Azu­ra Oph­thalmics gets a $20M boost for its R&D work on eye dis­eases

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Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with ...

22 hours ago

Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

2 days ago

The prospect of an Oc­to­ber OK large­ly closed, Pfiz­er's Al­bert Bourla promis­es not to sub­mit for EUA un­til No­vem­ber

6 days ago
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A long-haul biotech with some im­pres­sive back­ers and big goals re­cruits a ma­jor league R&D ex­ec to the helm. What’s ...

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No­var­tis bet $6B on the idea — now Ver­sant, ven­Bio have $45M to birth a plat­form play for ra­dio­phar­ma­ceu­ti­cals

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Ven­rock takes the wrap off its first mi­cro­bio­me start­up, armed with $50M, a CEO from 23andMe and two founders from ...

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Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

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Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and ...

Yesterday

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

2 days ago
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Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

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Four biotechs and a Matthew Ro­den-led SPAC price IPOs, rais­ing a com­bined $528M

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Co­di­ak lands on Wall Street in sec­ond shot at IPO, rais­es $83M

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Lu­ca Santarel­li’s PhI­II is good to go, he has a new app to stop Covid-19 from in­fect­ing the da­ta and $110M to pave ...

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Roche turns to a Har­vard up­start out of George Church’s lab to con­struct AAV 2.0 mod­el vec­tors — a key part of ...

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Af­ter re­cruit­ing an As­traZeneca vet as CEO to head a new team and rais­ing $139M cash, lit­tle Ole­ma ap­pears to be ...

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Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — ...

Yesterday
Coronavirus

Covid-19 roundup: FDA has fi­nal­ly post­ed dis­cus­sion items for to­mor­row's ad­comm; As­traZeneca could soon re­sume US ...

Yesterday
Coronavirus

UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the ...

Yesterday
R&D
Cell/Gene Tx

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

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The End­points 11: Here are some of the most promis­ing star­tups in biotech. And Covid-19 is­n't go­ing to stop them

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The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

6 months ago
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Here are the 52 new drugs ap­proved by the FDA in 2019. Who won? Who lost? And who just sur­vived to 2020?

9 months ago
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Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

11 months ago
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Peer review See all

Oct
16

Ameet Nath­wani re­bounds from Sanofi purge to helm Dew­point; Ali Mor­taza­vi named CEO at e-ther­a­peu­tics

Oct
9

Brett Zbar to lead life sci­ences in­vest­ing at Gen­er­al At­lantic; Michael Ka­vanaugh plans re­tire­ment as Cy­tomX pro­motes ...

Oct
2

Phar­ma vet Va­le­ria Fan­tin jumps to on­col­o­gy team at Gilead; João Sif­fert out as Abeona looks for an­oth­er CEO

Sep
25

Sil­ver­back dish­es out two pro­mo­tions in C-suite; Leg­end CEO post changes hands again

Sep
18

Vedan­ta Bio­sciences taps Big Phar­ma vet Jef­frey Sil­ber as CMO; Robert Doe­bele leaves be­hind teach­ing post at Col­orado ...

R&D channel feed

3 days ago

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As cat­a­lysts go, few loom larg­er than the ad­u­canum­ab ad­comm slat­ed for Nov. 6. With its big fran­chise un­der as­sault, Bio­gen is bet­ting the ranch that its mixed late-stage ...

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Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And ...

3 days ago
Pharma

Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for ...

Yesterday
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Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

Yesterday

Pur­due Phar­ma signs guilty plea, preps $8B+ set­tle­ment on Oxy con­tro­ver­sy — re­port; Flag­ship brings in a comms chief

Yesterday
News Briefing

Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Yesterday

UP­DAT­ED: Left for dead af­ter a fail­ure in neu­ro­path­ic pain, Aptinyx latch­es on­to pos­i­tive PhII da­ta in PTSD

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

2 days ago
Coronavirus
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Pharma channel feed

3 days ago

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fat­ed pro­pos­al to ban re­bates for phar­ma­cy ben­e­fit man­agers to an ex­ec­u­tive or­der de­mand­ing a “most-fa­vored-na­tion price” for Medicare, if noth­ing else Pres­i­dent Don­ald ...

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UCB sketch­es grand plans for new head­quar­ters as it grabs Eli Lil­ly's aban­doned neu­ro R&D cam­pus

6 days ago

Vaxart was served a grand ju­ry sub­poe­na in Ju­ly over its con­tro­ver­sial role in OWS-fund­ed pre­clin­i­cal study

Last week
Regulatory
latest in Pharma

Sa­mi An­war raked in mil­lions of dol­lars gath­er­ing drug tri­al da­ta at his sites. But it was all a lie — and now he's been sen­tenced to 28 years

Last week
People

Drown­ing in lit­i­ga­tion, Mallinck­rodt be­comes third opi­oid pro­duc­er to file for bank­rupt­cy

Last week

As Trump touts his ‘great’ Covid drugs, the phar­ma cash flows to Biden, not him

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Seat­tle Ge­net­ics? Not any­more. The biotech has short­ened its name to Seagen to il­lus­trate glob­al ex­pan­sion

Last week

Op­di­vo/Yer­voy com­bo flops again in melanoma, but Bris­tol My­ers Squibb al­so has a new OK to cel­e­brate

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R&D
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Coronavirus channel feed

3 days ago

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a med­ley of ad­verse events hob­bling the late-stage de­vel­op­ment of vac­cines and drugs, Pfiz­er CEO Al­bert Bourla’s lat­est — ex­tend­ed — time­line for the mR­NA ap­proach ...

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UP­DAT­ED: Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

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Covid-19 roundup: Stéphane Ban­cel sees De­cem­ber EUA for Mod­er­na at ear­li­est; Trump trash­es Fau­ci as 'dis­as­ter' and ...

2 days ago
latest in Coronavirus

FDA of­fi­cials, ex­perts dis­cuss im­pact of Covid-19 on cell and gene ther­a­pies

6 days ago
Cell/Gene Tx
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Covid-19 roundup: Can Ab­b­Vie’s dis­ap­point­ing NASH drug ceni­crivi­roc find suc­cess fight­ing cy­tokine storms?; Trump al­ly Chris Christie says he re­ceived Lil­ly's an­ti­body cock­tail

6 days ago

WHO says remde­sivir has lit­tle ef­fect in hos­pi­tal­ized Covid-19 — but Gilead calls new da­ta 'in­con­sis­ten­t' with pre­vi­ous find­ings

6 days ago

Covid-19 roundup: Rus­sia ap­proves sec­ond vac­cine, Putin says; Ad­vo­ca­cy groups ask WTO to waive patent rights

Last week

The Sanofi/Trans­late team hits the green light on an ear­ly-stage study for their mR­NA Covid-19 vac­cine af­ter see­ing it work in an­i­mals

Last week
R&D
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