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What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more

Yesterday
Weekly

An­oth­er day, an­oth­er xeno­trans­plant, as Unit­ed Ther­a­peu­tics looks to beat com­peti­tors to sci-fi-es­que break­through

2 days ago
Pharma

Crit­ics push back on Alzheimer’s As­so­ci­a­tion ad blitz to get Medicare to change its Aduhelm rul­ing: 'Dead wrong'

2 days ago
Pharma
Marketing

Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

2 days ago
Pharma
FDA+

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Yingli Phar­ma brings small mol­e­cule re­search to the US in new pact with MD An­der­son; UCB's pso­ri­at­ic arthri­tis drug ...

2 days ago
News Briefing

Time lim­its on ac­cel­er­at­ed ap­provals? FDA's on­col­o­gy chief Rick Paz­dur eyes po­ten­tial re­forms via in­ter­na­tion­al ...

2 days ago
FDA+

Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

2 days ago
Coronavirus

Mer­ck wins le­gal bat­tle over in­sur­ance cov­er­age af­ter ran­somware at­tack

2 days ago
Pharma

Flori­da man con­vict­ed of fal­si­fy­ing clin­i­cal tri­al re­sults sen­tenced to over 2 years in prison

2 days ago
Outsourcing
FDA+

So what ex­act­ly does Ver­i­ly do? A new deal with L'Oréal does­n't clear up much

2 days ago
Deals
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People

Zymeworks re­places half its C-suite, aims to lay off 25% of to­tal work­force as new CEO takes over

3 days ago

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

5 days ago

Mar­tin Shkre­li re­ceives life­time in­dus­try ban, forced to re­turn al­most $65M in prof­its af­ter an­ti­com­pet­i­tive scheme

5 days ago
Financing

Psy­che­delics biotech set to go pub­lic via SPAC — push­ing IV form of psilo­cy­bin in­to PhI

3 days ago

A high-res mi­cro­scope the size of a toast­er? A mi­croscopy start­up earns big-name VC back­ers

3 days ago

Next-gen CAR-T play­er steps on the gas with a $111M boost and a pos­i­tive glimpse at ear­ly da­ta

4 days ago
Startups

Or­biMed takes point on a new biotech launch, but al­most every­thing re­mains se­cret for now

4 days ago

A new start­up wants to take an­ti­sense and siR­NA one step fur­ther, and build more po­tent drugs than Io­n­is and Al­ny­lam

4 days ago

British bil­lion­aire Mike Platt hops on board a Lon­don start­up look­ing at drug dis­cov­ery from a dif­fer­ent an­gle

5 days ago
Deals

Faced with in­tense in­vestor back­lash, Unilever now says $68B is its fi­nal of­fer for GSK con­sumer health­care busi­ness

3 days ago

UCB buys its way to epilep­sy show­down with Jazz with $1.9B Zo­genix ac­qui­si­tion

4 days ago

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron ...

5 days ago

Premium storiesSee all

'Al­tos was re­al­ly a once-in-a-life­time op­por­tu­ni­ty': Hal Bar­ron re­flects on his big move

3 days ago
Bioregnum
Cell/Gene Tx

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

4 days ago
FDA+

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

4 days ago
R&D
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#JPM22: High­lights for the year ahead in on­col­o­gy R&D — What's hot, what's not?

Last week
R&D

Don't missSee all

As Hal Bar­ron steals the show, there’s no off po­si­tion on the John Maraganore switch; Dan­ny Bar-Zo­har makes an­oth­er ...

3 days ago
Peer Review

Pub­li­cis Health snaps up R&D mar­ket­ing group track­ing re­al-world clin­i­cal tri­als – and pa­tient sen­ti­ment

3 days ago
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Marketing

A Sen­ate bill wants to even an 'un­lev­el play­ing field' for do­mes­tic, for­eign in­spec­tion drop-ins amid back­log

3 days ago
Manufacturing

Mer­ck com­mer­cial chief Frank Clyburn de­parts for CEO role at DuPont co-owned ad­di­tives com­pa­ny

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

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People
Special

How Chi­na turned the ta­bles on bio­phar­ma's glob­al deal­mak­ing

2 months ago
China
In Focus

Con­tract re­search is hav­ing a mo­ment right now. Will M&A splash­es dri­ve the in­dus­try to even greater heights?

3 months ago
Outsourcing
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The coro­n­avirus vac­cine that the world for­got could still help save it

3 months ago
Coronavirus
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Peer review See all

Jan
14

Er­ic Os­tertag reach­ing the end of the line as Po­sei­da chief, will be­come ex­ec­u­tive chair­man; Alec­tor ex­ec named CEO ...

Jan
7

How fam­i­ly and sci­ence moved Ex­elix­is' new CMO to work on on­col­o­gy block­busters; While John Maraganore racks up the ...

Dec
23

Joan Shen ends the year by say­ing good­bye to I-Mab; CRISPR Ther­a­peu­tics puts coal in R&D chief's stock­ing

Dec
17

Sara Kenkare-Mi­tra leaves Genen­tech for a chance to lead neu­ro R&D; Glax­o­SmithK­line alum jumps to Vi­for Phar­ma with ...

Dec
10

Flag­ship on cen­ter stage: Ax­cel­la’s new CMO likens the biotech to ‘pro­fes­sion­al sports team’; Life af­ter the ...

Pharma channel feed

3 days ago

Eu­ro­pean Par­lia­ment signs off on strength­en­ing drug reg­u­la­tor's abil­i­ty to tack­le short­ages

The Eu­ro­pean Par­lia­ment on Thurs­day en­dorsed a plan to in­crease the pow­ers of the Eu­ro­pean Med­i­cines Agency, which will be bet­ter equipped to mon­i­tor and mit­i­gate short­ages of drugs and ...

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

4 days ago

CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

5 days ago
FDA+
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Gilead says a net­work of sup­pli­ers and dis­trib­u­tors sold tens of thou­sands of fake ver­sions of its HIV meds

4 days ago
FDA+

As­traZeneca rolls out 'un­prece­dent­ed' 3-year sur­vival da­ta for PD-L1/CT­LA4 com­bo in liv­er can­cer

4 days ago
R&D

Ready for an M&A fight? Af­ter GSK shunned $68B of­fer, Unilever says it's still in hunt for con­sumer health JV

5 days ago
Deals

A $3B+ peak sales win? Pfiz­er thinks so, as FDA of­fers a tardy green light to its JAK1 drug abroc­i­tinib

Last week
FDA+

Ex­clu­sive: Bio­gen lead­ers warn sales teams: On­ly 2,000 pa­tients might ac­cess Aduhelm over the next sev­er­al years

Last week
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Marketing channel feed

5 days ago

Emer­gent TV ads book­end its tu­mul­tuous year. Can mil­i­tary, Nar­can work help re­hab its brand?

When the Covid-19 pan­dem­ic hit, Emer­gent BioSo­lu­tions was rel­a­tive­ly un­known. But the con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion (CD­MO) sud­den­ly hit the spot­light when it nabbed a ...

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Mar­ket­ingRx roundup: Aduhelm can’t get trac­tion with docs; Pfiz­er press­es vac­cine ef­fort dur­ing NFL play­offs

5 days ago
Pharma

Covid vac­cine mak­ers Pfiz­er, J&J notch high brand marks amid over­all still-strong phar­ma in­dus­try rep: Har­ris Poll

5 days ago
Pharma
latest in Marketing

Q&A: Bio­Marin com­mer­cial chief Jeff Ajer gears up for biggest drug launch to date — with an­oth­er wait­ing in the wings

5 days ago
Pharma

Ogilvy Health’s new chief cre­ative of­fi­cer Adam Hes­sel con­tem­plates cre­ative pros and cons of Covid

5 days ago
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Ar­genx de­buts first DTC for myas­the­nia gravis med Vyv­gart even as MG com­mu­ni­ty ef­fort con­tin­ues

5 days ago
Pharma

#JPM22: The fire­side chat with Take­da CEO Christophe We­ber

Last week

Twit­ter aims to bring med­ical con­fer­ences — and ad spon­sors — from ‘in­side 4 walls and 3 days’ to dig­i­tal fu­ture

Last week
Pharma
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FDA+ channel feed

3 days ago

FDA lifts par­tial hold on Ku­ra's Phase Ib AML pro­gram as biotech re­dou­bles mit­i­ga­tion ef­forts

Ku­ra On­col­o­gy is clear to re­sume stud­ies for its ear­ly-stage leukemia pro­gram af­ter the FDA lift­ed a clin­i­cal hold Thurs­day af­ter­noon.

READ MORE

Califf on ac­cel­er­at­ed ap­provals: Com­pa­nies need to do more work be­fore FDA says OK

3 days ago

With few re­main­ing un­ap­proved drugs, re­searchers tell FDA its Un­ap­proved Drugs Ini­tia­tive is no longer ef­fec­tive

5 days ago
latest in FDA+

A Tony Coles Parkin­son's biotech, Yu­man­i­ty, con­tin­ues its back­slide as lead pro­gram earns a par­tial hold

4 days ago

Al­most three years af­ter whiff­ing in a con­fir­ma­to­ry study, Mer­ck touts new da­ta for Keytru­da in HCC

4 days ago

No stranger to head­winds, blue­bird runs in­to two PDU­FA de­lays un­re­lat­ed to new safe­ty is­sues

5 days ago
R&D

Eu­rope preps for the launch of its new clin­i­cal tri­als data­base, with a push to in­crease tri­al par­tic­i­pa­tion

Last week

Rob Califf ad­vances as Biden's FDA nom­i­nee, with a close com­mit­tee vote

Last week
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Manufacturing channel feed

3 days ago

Man­u­fac­tur­ing woes con­tin­ue for Au­robindo af­ter FDA's warn­ing let­ter

An ac­tive phar­ma­ceu­ti­cal in­gre­di­ent site in In­dia has been hand­ed a warn­ing let­ter from the FDA, fol­low­ing an Au­gust 2021 in­spec­tion.

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Fol­low­ing CRL, Re­vance says it's clear on in­struc­tions for re­sub­mit­ting BLA

3 days ago

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

4 days ago
Financing
latest in Manufacturing

Re­call re­port: Miss­ing la­bel, mi­cro­bial con­t­a­m­i­na­tion leads to re­call of two batch­es of two drugs

3 days ago

Covid-19 man­u­fac­tur­ing roundup: New pro­duc­tion site opens in Africa; Sen­a­tor calls for test prices to be slashed

3 days ago

Johns Hop­kins and lo­cal biotech team up for new man­u­fac­tur­ing site; New oral drug plat­form to help ac­cel­er­ate R&D time­line

3 days ago

UK up­start rais­es $100M in bid to dig­i­tize and stan­dard­ize cell and gene ther­a­py man­u­fac­tur­ing

5 days ago
Cell/Gene Tx

Fol­low­ing a tu­mul­tuous year, Emer­gen­t's founder will re­tire in April

Last week
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