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UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Yesterday
Regulatory
Coronavirus

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

2 days ago
Regulatory
Coronavirus

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite ...

2 days ago
Pharma
Regulatory

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

3 hours ago
R&D

Latest

Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

Yesterday
R&D

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

2 days ago
IPOs

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred ...

2 days ago
Deals
Cell/Gene Tx

News brief­ing: Gilead com­pletes $21B buy­out of Im­munomedics; In­nate re­ceives $50M mile­stone pay­ment from As­traZeneca

2 days ago
News Briefing

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

2 days ago
R&D

Arndt Rolfs steps aside as Cen­to­gene CEO, with An­drin Os­wald named as his suc­ces­sor; João Sif­fert lands an­oth­er CEO ...

2 days ago
Peer Review
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People

UP­DAT­ED: In­di­v­ior's Shaun Thax­ter heads to prison, join­ing In­sys' John Kapoor among jailed opi­oid ex­ecs

2 days ago

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

4 days ago

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

5 days ago
Startups

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

3 days ago

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

3 days ago

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

3 days ago
Deals

Retrophin beefs up the rare dis­ease drug pipeline with a $517M buy­out deal

2 days ago

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

3 days ago

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

3 days ago
IPOs

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues ...

2 days ago

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

5 days ago

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

Last week

Premium storiesSee all

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 ...

Last week
Venture

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

Last week
People
Startups

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

Last week
Deals
Cell/Gene Tx

What are the right in­gre­di­ents for a block­buster uni­corn IPO? Nor­bert Bischof­berg­er has some thoughts on that

3 weeks ago
Bioregnum
IPOs

Don't missSee all

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by ...

3 days ago
Coronavirus

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

4 days ago
Coronavirus

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

4 days ago
R&D

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

4 days ago
Coronavirus

Endpoints Standouts

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

4 weeks ago
Startups
In Focus

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

6 months ago
People
Special

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
Special
Pharma

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

11 months ago
People
R&D

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

4 days ago

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

Just days af­ter sci­en­tif­ic founder Em­manuelle Char­p­en­tier shared the No­bel prize for her work on CRISPR/Cas9, CRISPR Ther­a­peu­tics $CR­SP is show­ing off a snap­shot of suc­cess in their ear­ly-stage ...

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

3 days ago

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

4 days ago
latest in R&D

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

4 days ago

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

4 days ago
News Briefing

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

4 days ago

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

5 days ago

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

5 days ago
Coronavirus
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Pharma channel feed

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

6 days ago
R&D

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

Last week
latest in Pharma

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

Last week
People
Coronavirus

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

Last week
Regulatory

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

3 weeks ago
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Coronavirus channel feed

2 days ago

Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for Cure­Vac $CVAC is com­ing up with a loom­ing ear­ly-stage read­out on their mR­NA Covid-19 vac­cine in the clin­ic. But for now they’ll make do with an up­beat as­sess­ment on the ...

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

3 days ago
Regulatory

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

4 days ago
latest in Coronavirus

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

5 days ago
Regulatory

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

5 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

6 days ago

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

Last week
Cell/Gene Tx
Regulatory

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

Last week
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