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George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

23 hours ago
People
Financing
Cell/Gene Tx

Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; ...

8 hours ago
Weekly

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

23 hours ago
R&D
FDA+

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

4 hours ago
R&D
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Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Yesterday
FDA+

#AAO22: Iver­ic Bio, un­de­terred by loom­ing PDU­FA for com­peti­tor, touts sub­group da­ta on GA drug

21 hours ago
R&D

#AAO22: In bid for first FDA nod in ge­o­graph­ic at­ro­phy, Apel­lis claims an­oth­er first in eye dis­ease field

21 hours ago
R&D
Pharma

BioCryst launch­es aware­ness cam­paign around man­age­ment of rare vas­cu­lar dis­ease

23 hours ago
Pharma
Marketing

EMA makes new rec­om­men­da­tions for Im­bru­vi­ca, med­i­cines with ter­li­pressin over res­pi­ra­to­ry and car­dio­vas­cu­lar risks

23 hours ago
Pharma

New in­fla­tion-linked drug re­bates go in­to ef­fect on Sat­ur­day

23 hours ago
Pharma
Law
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People

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

2 days ago

In sur­vival mode, Ex­i­cure cuts to the bone — paus­ing all R&D and chop­ping head­count by 66%

4 days ago

FDA's top gener­ic drug leader puts in her two weeks as GDU­FA III looms

5 days ago
Financing

Re­cent­ly out-of-stealth neu­ro­science out­fit un­veils cash raise, more de­tails on Lil­ly, North­west­ern pro­grams

Yesterday

Chi­na’s Yisheng­Bio is go­ing to Nas­daq, mak­ing the tran­si­tion via $230M SPAC ma­neu­ver

Yesterday

'Struc­ture, beau­ty and clar­i­ty': With seed fi­nanc­ing, Kalei­do­scope aims to syn­chro­nize R&D teams

3 days ago
Startups

Wyss In­sti­tute spin­out looks to re­vamp drug de­vel­op­ment for CNS dis­eases — with CRISPR tad­poles

3 days ago

Bris­tol My­ers got the first TYK2 ap­proval. Fra­zier’s new biotech Su­do hopes to get many more

3 days ago

A new ADC biotech looks to re­vive se­cre­tive plat­form, se­cures Big VC back­ing

3 days ago
Deals

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Yesterday

Siga nabs $10.7M from the US gov­ern­ment in deal for its mon­key­pox an­tivi­ral

2 days ago

Almi­rall part­ners up with Sim­cere in po­ten­tial $500M+ deal — with plans to take IL-2 can­di­date glob­al

2 days ago

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Sanofi turns to a Jen­nifer Doud­na gene edit­ing up­start for next-gen NK cell al­liance

4 days ago
Deals

Even as pan­dem­ic re­cedes, short-staffed tri­al sites leave can­cer pa­tients wait­ing

4 days ago
R&D
Pharma

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

Last week

An­ti­bod­ies once act­ed on­ly as pro­tein block­ers. Now, sci­en­tists are find­ing new ways to make them pro­tein de­stroy­ers

Last week
Discovery

In FocusSee all

Chi­na's DNA gi­ant con­fronts skep­ti­cism in US ex­pan­sion bid

Last month
China
Diagnostics

Af­ter years of fail­ures, the hunt for a new type of Parkin­son’s drug is on

Last month
R&D

Biotech's 'sug­ar high' led to a cor­rec­tion, but win­ter dol­drums could make way for a turn­around sto­ry this fall

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Financing

Biotech’s down­turn fu­els a bil­lion­aire’s niche in­vest­ment in­dus­try

Last month
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In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Yesterday
R&D

Bio­Marin re­turns to FDA with a new pitch for he­mo­phil­ia gene ther­a­py — and a promise to get to the bot­tom of ...

Yesterday
Cell/Gene Tx
FDA+

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

Yesterday
FDA+

FDA's ad­vanced ther­a­pies of­fice pro­vides more clar­i­ty on gene ther­a­py CMC con­sid­er­a­tions

Yesterday
Pharma
Cell/Gene Tx

Endpoints Standouts

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

4 months ago
People
Discovery

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

5 months ago
Special

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

7 months ago
Financing
Deals

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

9 months ago
People
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Peer review See all

Sep
30

'Don't eat me' up­start taps Take­da vet on path to the clin­ic; Greg Mayes leaves An­tios for Cana­di­an psy­che­delics ...

Sep
23

Amid mas­sive turnover, Agios hires Bio­gen alum as new CFO; Schol­ar Rock, Ever­est Med­i­cines lead the big CEO pa­rade

Sep
16

Scor­pi­on snags a Sanofi vet to lead the way to the clin­ic; All eyes on eli-cel as blue­bird seeks a fi­nance leader — ...

Sep
9

Ho­mol­o­gy sails with same cap­tains in dif­fer­ent seats; Ex-Har­poon chief weath­ers the Storm at UK biotech

Sep
2

Jay Brad­ner’s NI­BR ex­it sets off a suc­ces­sion plan at Mer­ck; Dyne and Mor­phoSys fill ma­jor R&D roles

Pharma channel feed

2 days ago

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mount­ing its coun­ter­feit drug law­suit, nam­ing two “king­pins” and a com­plex net­work of con­spir­a­tors who al­leged­ly sold im­i­ta­tion bot­tles of its HIV meds, some of which end­ed up ...

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An­oth­er Avastin biosim­i­lar joins the par­ty as Roche's grip on the mar­ket loosens

3 days ago

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

3 days ago
Manufacturing
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Mer­ck cel­e­brates an­oth­er win in Janu­via patent bat­tle against Vi­a­tris

Yesterday
Law

CMS spent more than $18B in four years on ac­cel­er­at­ed ap­provals with in­com­plete con­fir­ma­to­ry tri­als, in­spec­tor gen­er­al finds

Yesterday
FDA+

Sanofi, Re­gen­eron’s Dupix­ent scores an­oth­er in­di­ca­tion with first-ever ap­proval for nodu­lar skin dis­or­der

2 days ago
FDA+

Vor Bio opts to keep man­u­fac­tur­ing op­er­a­tions in-house for de­vel­op­ing stem cell, CAR-T ther­a­pies

2 days ago
Manufacturing

What more can we learn from DTC ad­ver­tis­ing? FDA's OPDP pro­pos­es new re­search

3 days ago
FDA+
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Marketing channel feed

2 days ago

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eye­lid mite dis­ease may be "gross" but it's al­so fair­ly com­mon, af­fect­ing about 25 mil­lion peo­ple in the US.

READ MORE

Sanofi us­es cre­ative cam­ou­flage in physi­cian-tar­get­ed cam­paign for po­ten­tial can­cer bio­mark­er

3 days ago
Pharma

J&J de­buts Ken­vue as new name for $15B con­sumer health busi­ness spin­off

3 days ago
Pharma
latest in Marketing

Pa­tient re­port finds con­sti­pa­tion con­di­tion not well-man­aged, open­ing door for bet­ter ed­u­ca­tion from phar­ma

2 days ago
Pharma

Ab­b­Vie teams up with Shut­ter­stock to re­de­fine beau­ty in lat­est aes­thet­ics cam­paign

4 days ago
Pharma

Genen­tech de­buts next it­er­a­tion of its Ocre­vus MS cam­paign, tar­get­ing GenZ and His­pan­ic au­di­ences

4 days ago
Pharma

From Covid ad boom to en­dem­ic: Track­ing TV ads from first rush of brand ca­ma­raderie to to­day’s phar­ma boost­ers

4 days ago
Pharma

Mar­ket­ingRx roundup: Mod­er­na en­cour­ages fall boost­ers; Roche's Genen­tech amps its STEM di­ver­si­ty pro­gram

4 days ago
Pharma
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FDA+ channel feed

5 days ago

Three with­drawals in ad­vanced ovar­i­an can­cer spell trou­ble for PARP class

When As­traZeneca and Mer­ck’s PARP in­hibitor Lyn­parza was ap­proved for ad­vanced ovar­i­an can­cer back in 2014, FDA's cur­rent On­col­o­gy Cen­ter of Ex­cel­lence di­rec­tor Richard Paz­dur tout­ed it ...

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Sen­ate pass­es bill to re­work an­i­mal test­ing re­quire­ments for drug de­vel­op­ers

2 days ago
Law

Cell and gene ther­a­pies from acad­e­mia: EMA to help 5 projects go­ing af­ter un­met clin­i­cal needs

2 days ago
Cell/Gene Tx
latest in FDA+

Re­al-time re­views for cell and gene ther­a­pies? Pfiz­er to FDA: Yes, please

3 days ago
Cell/Gene Tx

For­mer No­var­tis drug for ul­tra-rare dis­ease gets speedy FDA re­view

3 days ago

FDA's OTAT morphs in­to the Of­fice of Ther­a­peu­tic Prod­ucts as new funds await

4 days ago

Man­u­fac­tur­ing sites in Ger­many and Chi­na hit with warn­ing let­ters over QC and clean­ing is­sues

4 days ago
Pharma
Manufacturing

Now play­ing catch-up to blue­bird, Ver­tex and CRISPR send in their pitch for blood dis­or­der cell ther­a­py

4 days ago
Cell/Gene Tx
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Manufacturing channel feed

4 days ago

Ipsen be­comes the lat­est phar­ma to ex­pand in Ire­land, with a $50M in­vest­ment in its fa­cil­i­ty in Dublin sub­urbs

It is no se­cret that Ire­land has be­come a hot spot for phar­ma man­u­fac­tur­ing projects over the past year, and it seems that Ipsen will be the lat­est play­er to get in on the ac­tion.

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Man­u­fac­tur­ing roundup: Ace­to re­brands to Actylis; WuXi STA opens an­oth­er fa­cil­i­ty

2 days ago

Emer­gent clos­es on buy­ing small­pox drug Tem­bexa from Chimerix with a $238M pay­ment

4 days ago
Deals
Pharma
latest in Manufacturing

Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Last week

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

Last week
Pharma
FDA+

EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

Last week
Pharma

Man­u­fac­tur­ing roundup: Lon­za fin­ish­es ex­pand­ing Visp site; CBM to pro­duce jCyte’s cell ther­a­py

Last week

Armed with cash, Bel­gian iP­SC play­er makes a play for Celyad’s cell ther­a­py man­u­fac­tur­ing site

Last week
Deals
Cell/Gene Tx
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